Wechselwirkungen von Cariprazin

Die Kombination von Alkohol mit sedierenden Arzneimitteln (Opioide, Benzodiazepine, Schlafmittel, Muskelrelaxanzien) kann gefährliche Schläfrigkeit, verlangsamte Atmung und eine Überdosierung verursachen. (NIAAA, Harmful Interactions: Mixing Alcohol with Medicines)

• Effects on Driving and Operating Machinery: Patients receiving • alprazolam XR should be cautioned against operating machinery or driving a motor vehicle, as well as avoiding concomitant use of alcohol and other central nervous system (CNS) depressant drugs. (Fachinformation zu Alprazolam, Warnhinweise und Vorsichtsmaßnahmen)

…the description of tardive dyskinesia and its clinical detection, please refer to the sections on Information for Patients and ADVERSE REACTIONS . ) Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs and with amoxapine. (Fachinformation zu Amoxapin, Warnhinweise)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Cerebrovascular Adverse Reactions, Including Stroke , in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

…phenobarbital, phenytoin Antiarrhythmics Amiodarone (with ritonavir), quinidine (with ritonavir) Antimycobacterials Rifampin Antineoplastics Apalutamide, encorafenib, irinotecan, ivosidenib Antipsychotics Lurasidone (with ritonavir), pimozide Benzodiazepines Orally administered midazolam a , triazolam Ergot Derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine… (Fachinformation zu Atazanavir, Gegenanzeigen)

• Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with azelastine hydrochloride and fluticasone propionate nasal spray because further decreased alertness and impairment of CNS performance may occur. (Fachinformation zu Azelastin und Fluticason, Warnhinweise und Vorsichtsmaßnahmen)

…AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOD WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Belladonna and opium suppositories expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to… (Fachinformation zu Belladonna und Opium, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

The concomitant use of CYCLOSET and dopamine receptor antagonists, including neuroleptic drugs, is not recommended. (Fachinformation zu Bromocriptin, Warnhinweise und Vorsichtsmaßnahmen)

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Buprenorphin, Boxed Warning (umrahmter Warnhinweis))

Concomitant use of opioids or a barbiturate with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Butalbital, Acetylsalicylsäure, Koffein und Codein, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Butalbital, Paracetamol, Koffein und Codein, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Butorphanol, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Avoid concurrent use of Carbinoxamine Maleate Extended-Release Oral Suspension with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur. (Fachinformation zu Carbinoxamin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur. (Fachinformation zu Cetirizin, Warnhinweise und Vorsichtsmaßnahmen)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Chlordiazepoxid, Warnhinweise)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Chlordiazepoxid und Clidiniumbromid, Warnhinweise)

Table 8: Drugs That are Affected by and Affecting Ciprofloxacin Drugs That are Affected by Ciprofloxacin Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications ( 4.2 )]. (Fachinformation zu Ciprofloxacin, Arzneimittelwechselwirkungen)

Colchicine (in patients with normal renal and hepatic function) Use With Caution Antipsychotics: Pimozide Contraindicated Pimozide: [See Contraindications ( 4.2 )] Quetiapine Lurasidone Quetiapine: Quetiapine is a substrate for CYP3A4, which is inhibited by clarithromycin. (Fachinformation zu Clarithromycin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Clonazepam, Warnhinweise)

Avoid use with other central nervous system (CNS) depressants ( 5.3 ) (Fachinformation zu Clonidin, Warnhinweise und Vorsichtsmaßnahmen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Codein, Boxed Warning (umrahmter Warnhinweis))

Based on its structural similarity to TCAs, concomitant use of TONMYA with: MAO inhibitors may be life-threatening [see Contraindications (4) ] , Alcohol, barbiturates, and other CNS depressants may increase the risk of adverse reactions associated with these drugs, Tramadol may increase the seizure risk, Guanethidine or other similar acting drugs may block the… (Fachinformation zu Cyclobenzaprin, Arzneimittelwechselwirkungen)

Alpha 1-adrenoreceptor antagonist: alfuzosin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine Herbal product: St. (Fachinformation zu Darunavir, Gegenanzeigen)

…antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine Herbal product: St. (Fachinformation zu Darunavir und Cobicistat, Gegenanzeigen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission. (Fachinformation zu Deutetrabenazin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Diazepam, Warnhinweise)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Dikaliumclorazepat, Warnhinweise)

CONTRAINDICATIONS Diphenoxylate hydrochloride and atropine sulfate is contraindicated in: • Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS ). (Fachinformation zu Diphenoxylat und Atropin, Gegenanzeigen)

Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended ( 5.1 ) (Fachinformation zu Doxylamin und Pyridoxin, Warnhinweise und Vorsichtsmaßnahmen)

…Clinical Pharmacology (12.3) ] • Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of torsade de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics • Liver or lung toxicity related to the previous use of amiodarone… (Fachinformation zu Dronedaron, Gegenanzeigen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine Herbal Products: St. (Fachinformation zu Elvitegravir, Cobicistat, Emtricitabin und Tenofovir, Gegenanzeigen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Estazolam, Warnhinweise)

The use of LUNESTA with other sedative-hypnotics at bedtime or the middle of the night is not recommended. (Fachinformation zu Eszopiclon, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Fentanyl, Boxed Warning (umrahmter Warnhinweis))

…coadministered with the following drugs: Alpha 1-adrenoreceptor antagonist: Alfuzosin Antiarrhythmics: Flecainide (with ritonavir ), propafenone (with ritonavir ) Antimycobacterial: Rifampin Antipsychotic: Lurasidone (with ritonavir ), pimozide Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine GI motility agent: Cisapride Herbal product: St. (Fachinformation zu Fosamprenavir, Gegenanzeigen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

• Respiratory Depression: May occur with NEURONTIN when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. (Fachinformation zu Gabapentin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Hydrocodon, Boxed Warning (umrahmter Warnhinweis))

…ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;… (Fachinformation zu Hydrocodon und Chlorphenamin, Boxed Warning (umrahmter Warnhinweis))

…ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and… (Fachinformation zu Hydrocodon und Homatropin, Boxed Warning (umrahmter Warnhinweis))

…LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P4503A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS Addiction,… (Fachinformation zu Hydrocodon und Ibuprofen, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Hydrocodon und Paracetamol, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . (Fachinformation zu Hydromorphon, Boxed Warning (umrahmter Warnhinweis))

Rarely, cardiac arrests and death have been reported in association with the combined use of hydroxyzine hydrochloride intramuscularly and other CNS depressants. (Fachinformation zu Hydroxyzin, Vorsichtsmaßnahmen)

Benzodiazepines, Opioid Analgesics, or other CNS Depressants : Concomitant use may result in profound sedation, respiratory depression, coma, or death. (Fachinformation zu Ketamin, Arzneimittelwechselwirkungen)

This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. (Fachinformation zu Ketoconazol, Gegenanzeigen)

Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL. (Fachinformation zu Levocetirizin, Warnhinweise und Vorsichtsmaßnahmen)

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Levorphanol, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Caution patients receiving LOREEV XR against operating machinery or driving a motor vehicle as well to avoid the concomitant use of alcohol and other CNS depressant drugs during treatment ( 5.4 , 7 ) (Fachinformation zu Lorazepam, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Agranulocytosis (including fatal cases) has been reported with other antipsychotic drugs. (Fachinformation zu Lumateperon, Warnhinweise und Vorsichtsmaßnahmen)

If concomitant use with another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. (Fachinformation zu Metaxalon, Warnhinweise und Vorsichtsmaßnahmen)

Managing Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death [see Warnings and Precautions ( 5.2 )]. (Fachinformation zu Methadon, Boxed Warning (umrahmter Warnhinweis))

• Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. (Fachinformation zu Metoclopramid, Warnhinweise und Vorsichtsmaßnahmen)

WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer… (Fachinformation zu Midazolam, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Morphin, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Nalbuphin, Boxed Warning (umrahmter Warnhinweis))

Risk of Recurrent Respiratory and CNS Depression : A recurrence of respiratory depression is possible, therefore, keep the patient under continued surveillance and administer repeat doses of ZURNAI using a new auto-injector with each dose while awaiting emergency medical assistance. (Fachinformation zu Nalmefen, Warnhinweise und Vorsichtsmaßnahmen)

• Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. (Fachinformation zu Natriumoxybat, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Neuropsychiatric agents suvorexant ↑ suvorexant Avoid concomitant use of suvorexant with PAXLOVID. aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin ↑ aripiprazole ↑ brexpiprazole ↑ cariprazine ↑ iloperidone ↑ lumateperone ↑ pimavanserin Dosage adjustment of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, and… (Fachinformation zu Nirmatrelvir und Ritonavir, Arzneimittelwechselwirkungen)

Cerebrovascular Adverse Reactions, Including Stroke , in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Cerebrovascular Adverse Reactions, Including Stroke , in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Oliceridin, Boxed Warning (umrahmter Warnhinweis))

• Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride nasal solution (nasal spray) ( 5.2 ). (Fachinformation zu Olopatadin, Warnhinweise und Vorsichtsmaßnahmen)

• Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with RYALTRIS because additional reductions in alertness and additional impairment of CNS performance may occur. (Fachinformation zu Olopatadin und Mometason, Warnhinweise und Vorsichtsmaßnahmen)

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Oxazepam, Warnhinweise)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Oxycodon, Boxed Warning (umrahmter Warnhinweis))

…LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Oxycodone hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to… (Fachinformation zu Oxycodon und Paracetamol, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Oxymorphon, Boxed Warning (umrahmter Warnhinweis))

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Paracetamol und Codein, Boxed Warning (umrahmter Warnhinweis))

…MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Pentazocine and Naloxone Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to… (Fachinformation zu Pentazocin und Naloxon, Boxed Warning (umrahmter Warnhinweis))

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Pethidin, Boxed Warning (umrahmter Warnhinweis))

Phenelzine sulfate should not be used in combination with dextromethorphan or with CNS depressants such as alcohol and certain narcotics. (Fachinformation zu Phenelzin, Gegenanzeigen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

• Respiratory Depression : May occur with LYRICA when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. (Fachinformation zu Pregabalin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

…PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Promethazine HCl and Codeine Phosphate Oral Solution exposes patients and other users to the risks… (Fachinformation zu Promethazin und Codein, Boxed Warning (umrahmter Warnhinweis))

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Remifentanil, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Cerebrovascular Adverse Reactions, Including Stroke , in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Tapentadol, Boxed Warning (umrahmter Warnhinweis))

Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. (Fachinformation zu Temazepam, Warnhinweise)

Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with tetrabenazine tablets and other drugs that reduce dopaminergic transmission [see Drug Interactions (7.6) ]. (Fachinformation zu Tetrabenazin, Warnhinweise und Vorsichtsmaßnahmen)

…proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see WARNINGS , CONTRAINDICATIONS… (Fachinformation zu Thioridazin, Boxed Warning (umrahmter Warnhinweis))

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Tramadol, Boxed Warning (umrahmter Warnhinweis))

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (Fachinformation zu Tramadol und Paracetamol, Boxed Warning (umrahmter Warnhinweis))

• Effects on Driving and Operating Heavy Machinery : Patients receiving triazolam should be cautioned against driving or operating heavy machinery, as well as avoiding concomitant use with alcohol and other CNS depressant drugs. (Fachinformation zu Triazolam, Warnhinweise und Vorsichtsmaßnahmen)

Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with dose reduction or discontinuation of trihexyphenidyl. (Fachinformation zu Trihexyphenidyl, Warnhinweise)

Avoid trimethobenzamide hydrochloride capsules in patients receiving other drugs that are likely to cause EPS (e.g. antipsychotics) [see Drug Interactions (7.2) ] . (Fachinformation zu Trimethobenzamid, Warnhinweise und Vorsichtsmaßnahmen)

Neuroleptic Malignant Syndrome (NMS ) A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission. (Fachinformation zu Valbenazin, Warnhinweise und Vorsichtsmaßnahmen)

The use of zaleplon with other sedative-hypnotics at bedtime or the middle of the night is not recommended (see ). (Fachinformation zu Zaleplon, Warnhinweise)

As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. (Fachinformation zu Ziprasidon, Warnhinweise und Vorsichtsmaßnahmen)

The use of Zolpidem Tartrate with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended. (Fachinformation zu Zolpidem, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Inform patients also that the central nervous system depressant effects of allopurinol tablets may be additive to those of alcohol and other CNS depressants. (Fachinformation zu Allopurinol, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

25% increase Diazepam Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while theophylline blocks adenosine receptors. (Fachinformation zu Aminophyllin, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Patients should also be cautioned that the central nervous system depressant effects of intrathecal baclofen may be additive to those of alcohol and other CNS depressants. (Fachinformation zu Baclofen, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Sedatives/Hypnotics: midazolam (oral) triazolam ↑ midazolam (oral) ↑ triazolam Use caution when midazolam or triazolam is concomitantly administered with BIXLENVO. (Fachinformation zu Bictegravir, Emtricitabin und Tenofoviralafenamid, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Use with CNS depressants may result in an additive or potentiating effect. (Fachinformation zu Brimonidin, Arzneimittelwechselwirkungen)

Use with CNS depressants may result in an additive or potentiating effect. (Fachinformation zu Brimonidin und Timolol, Arzneimittelwechselwirkungen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness. (Fachinformation zu Bupivacain, Warnhinweise und Vorsichtsmaßnahmen)

Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness. (Fachinformation zu Bupivacain und Adrenalin, Warnhinweise und Vorsichtsmaßnahmen)

Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with buprenorphine and naloxone sublingual tablets [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . (Fachinformation zu Buprenorphin und Naloxon, Warnhinweise und Vorsichtsmaßnahmen)

The following conditions can also increase the risk of seizure: concomitant use of other medications that lower the seizure threshold (e.g., other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids), metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia), or use of… (Fachinformation zu Bupropion, Warnhinweise und Vorsichtsmaßnahmen)

Triazolam/flurazepam: Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine. (Fachinformation zu Buspiron, Arzneimittelwechselwirkungen)

Butalbital and acetaminophen may enhance the effects of:other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. (Fachinformation zu Butalbital und Paracetamol, Arzneimittelwechselwirkungen)

Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. (Fachinformation zu Butalbital, Acetylsalicylsäure und Koffein, Arzneimittelwechselwirkungen)

Butalbital, acetaminophen and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. (Fachinformation zu Butalbital, Paracetamol und Koffein, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Other CNS depressants, including alcohol, could potentiate the somnolence and sedation effect of EPIDIOLEX. (Fachinformation zu Cannabidiol (verschreibungspflichtig), Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Hyperpyrexia and Confusion Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, carbidopa-levodopa, or carbidopa-levodopa extended release. (Fachinformation zu Carbidopa, Warnhinweise)

Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. (Fachinformation zu Carbidopa und Levodopa, Warnhinweise und Vorsichtsmaßnahmen)

Withdrawal-Emergent Hyperpyrexia and Confusion Cases of hyperpyrexia and confusion resembling neuroleptic malignant syndrome (NMS) have been reported in association with dose reduction or withdrawal of therapy with carbidopa, levodopa and entacapone. (Fachinformation zu Carbidopa, Levodopa und Entacapon, Warnhinweise und Vorsichtsmaßnahmen)

• Additive sedative effects when used with other CNS depressants including alcohol (5.1) (Fachinformation zu Carisoprodol, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin.) The concomitant use of alcohol or other central nervous system depressants may have an additive effect. (Fachinformation zu Chlorzoxazon, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). (Fachinformation zu Citalopram, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Antipsychotics and Antianxiety Agents The concomitant administration of RYANODEX with antipsychotic and antianxiety agents may potentiate their effects on the central nervous system [see Warnings and Precautions ( 5.2 )] . (Fachinformation zu Dantrolen, Arzneimittelwechselwirkungen)

CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. (Fachinformation zu Daridorexant, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, and muscle relaxants). (Fachinformation zu Dronabinol, Warnhinweise und Vorsichtsmaßnahmen)

Since it may be difficult to distinguish neuroleptic malignant syndrome from malignant hyperpyrexia in the perioperative period, prompt treatment with dantrolene should be considered if increases in temperature, heart rate or carbon dioxide production occur. (Fachinformation zu Droperidol, Warnhinweise)

Observe patients carefully when the dosage of NORTHERA is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. (Fachinformation zu Droxidopa, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. (Fachinformation zu Flibanserin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Possible risk factors for seizures include: concurrent major sedative-hypnotic drug withdrawal, recent therapy with repeated doses of parenteral benzodiazepines, myoclonic jerking or seizure activity prior to flumazenil administration in overdose cases, or concurrent cyclic antidepressant poisoning. (Fachinformation zu Flumazenil, Warnhinweise)

Coadministration of fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution. (Fachinformation zu Fluoxetin, Arzneimittelwechselwirkungen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

CNS Active Drugs Antipsychotics: See Warnings and Precautions ( 5.2 ) . (Fachinformation zu Fluvoxamin, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Avoid co-administration of CONTEPO with drugs known to prolong the QT interval, such as class IA or class III antiarrhythmic medications, tricyclic antidepressants, macrolides, and antipsychotics [see Warnings and Precautions ( 5.2 )] . (Fachinformation zu Fosfomycin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid… (Fachinformation zu Glimepirid, Arzneimittelwechselwirkungen)

The following are examples of medication that may reduce the glucose-lowering effect of GLUCOTROL XL, leading to worsening glycemic control: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease… (Fachinformation zu Glipizid, Arzneimittelwechselwirkungen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

CNS Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. (Fachinformation zu Lemborexant, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. (Fachinformation zu Levodopa, Warnhinweise und Vorsichtsmaßnahmen)

Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness. (Fachinformation zu Lidocain und Adrenalin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

• Encephalopathic Syndrome: Increased risk in patients treated with lithium and an antipsychotic. (Fachinformation zu Lithium, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…others drugs or herbal products that are known to prolong the QT interval, including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), or any other drug known to prolong the QT interval (e.g., pentamidine,… (Fachinformation zu Loperamid, Warnhinweise)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Additive Effects Since the effects of meprobamate and alcohol or meprobamate and other CNS depressants or psychotropic drugs may be additive,appropriate caution should be exercised with patients who take more than one of these agents simultaneously. (Fachinformation zu Meprobamat, Warnhinweise)

CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. (Fachinformation zu Methocarbamol, Warnhinweise und Vorsichtsmaßnahmen)

The CNS-depressant effect of BREVITAL may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol. (Fachinformation zu Methohexital, Warnhinweise)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Concurrent use of metyrosine with alcohol or other CNS depressants can increase their sedative effects. (Fachinformation zu Metirosin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Pharmacokinetic studies between moxifloxacin and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. (Fachinformation zu Moxifloxacin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

WARNINGS AND PRECAUTIONS Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, respiratory and CNS depression may recur after the first dose of naloxone. (Fachinformation zu Naloxon, Warnhinweise und Vorsichtsmaßnahmen)

…medications (sulfonylureas and meglitinides) that may cause hypoglycemia concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic steroids Recommendations for Reducing the Risk of Seizure: Clinical experience with bupropion suggests that the risk… (Fachinformation zu Naltrexon und Bupropion, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid… (Fachinformation zu Pioglitazon und Glimepirid, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Hyperpyrexia and Confusion Although not reported with pramipexole in the clinical development program, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction,… (Fachinformation zu Pramipexol, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

As with other sedative medications, there is wide interpatient variability in DIPRIVAN dosage requirements, and these requirements may change with time. (Fachinformation zu Propofol, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

The use of alcohol and other CNS depressants may increase the risk of such behaviors. (Fachinformation zu Ramelteon, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in drugs that increase central… (Fachinformation zu Rasagilin, Warnhinweise und Vorsichtsmaßnahmen)

Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction of, withdrawal of, or changes in, dopaminergic therapy. (Fachinformation zu Ropinirol, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Withdrawal Emergent Hyperpyrexia and Confusion Although not reported with ZELAPAR in the clinical development program, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with… (Fachinformation zu Selegilin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

25% increase Diazepam Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while theophylline blocks adenosine receptors. (Fachinformation zu Theophyllin, Arzneimittelwechselwirkungen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

During the 8-week trial, serum insulin levels increased by 12 pmol/L in the VRAYLAR 1 mg to 2 mg per day group, 20 pmol/L in the VRAYLAR 2 mg to 4.5 mg per day group, and 8.5 pmol/L in the placebo group. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Hyperpyrexia and Confusion: In clinical trials, four cases of a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, and altered consciousness), similar to that reported in association with the rapid dose reduction or withdrawal of other dopaminergic drugs, have been reported in association with… (Fachinformation zu Tolcapon, Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin,… (Fachinformation zu Toremifen, Arzneimittelwechselwirkungen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Excessive reduction of blood glucose (additive effect) f CNS depressant agents (including opioids, alcohol, sedatives, hypnotics) Use with caution d Increased CNS depression Dietary supplements containing sympathomimetics Contraindicated a Antidepressants including but not limited to: Other MAOIs (e.g., linezolid, intravenous methylene blue, selective MAOIs)… (Fachinformation zu Tranylcypromin, Arzneimittelwechselwirkungen)

…are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). (Fachinformation zu Trazodon, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

VRAYLAR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions. (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (e.g., elderly patients, patients with dehydration, hypovolemia, and concomitant treatment with antihypertensive medications), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and… (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. (Fachinformation zu Cariprazin, Arzneimittelwechselwirkungen)

Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when ZONISADE is used with other drugs with sedative properties because of potential additive effects. (Fachinformation zu Zonisamid, Warnhinweise und Vorsichtsmaßnahmen)

Some cases presented with features resembling neuroleptic malignant syndrome. (Fachinformation zu Atomoxetin, Arzneimittelwechselwirkungen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Antihistamines Amphetamines may counteract the sedative effect of antihistamines. (Fachinformation zu Dexamfetamin, Arzneimittelwechselwirkungen)

In Drug-Induced CNS and Respiratory Depression Doxapram alone may not stimulate adequate spontaneous breathing or provide sufficient arousal in patients who are severely depressed either due to respiratory failure or to CNS depressant drugs, but may be used as an adjunct to established supportive measures and resuscitative techniques. (Fachinformation zu Doxapram, Warnhinweise)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

The “gasping syndrome” is characterized by central nervous system (CNS) depression, metabolic acidosis, and gasping respirations. (Fachinformation zu Epoetin alfa, Warnhinweise und Vorsichtsmaßnahmen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs; however, in humans, granisetron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. (Fachinformation zu Granisetron, Arzneimittelwechselwirkungen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

Examples: Atypical antipsychotics (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and… (Fachinformation zu Repaglinid, Arzneimittelwechselwirkungen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. (Fachinformation zu Tiagabin, Warnhinweise)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…placebo-controlled trials of adult patients with major depressive disorder, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) was greatest in the VRAYLAR 3 mg per day + antidepressant therapy arm (3.2%) compared with those taking VRAYLAR 1.5 mg per day + antidepressant therapy (2%) or those placebo-treated (1.3%). (Fachinformation zu Cariprazin, Warnhinweise und Vorsichtsmaßnahmen)

…adjustment is needed when SINGULAIR is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology (12.3) ]. (Fachinformation zu Montelukast, Arzneimittelwechselwirkungen)