Interação entre Buprenorfina + naloxona e Midazolam
Buprenorfina + naloxona e Midazolam: ambas as bulas profissionais sinalizam esta combinação com a linguagem mais forte, como uma contraindicação, uma advertência em caixa preta ou uma instrução para evitá-la.
Não combine sem a orientação de um prescritor. A linguagem da bula abaixo é a mais forte que a FDA usa.
O que dizem as bulas da FDA
Da bula de Buprenorfina + naloxona (Buprenorphine and Naloxone) · em vigor desde 2026-06-16
Many, but not all, post-marketing reports regarding coma and death involved misuse by self-injection or were associated with the concomitant use of buprenorphine and benzodiazepines or other CNS depressant, including alcohol.
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) ] .
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of buprenorphine and benzodiazepines and/or other CNS depressants (e.g., alcohol, non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids) increases…
As a routine part of orientation to buprenorphine treatment, educate patients about the risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, and alcohol.
There is no evidence to support dose limitations or arbitrary caps of buprenorphine as a strategy to address benzodiazepine use in buprenorphine-treated patients.
Da bula de Midazolam (Midazolam in Sodium Chloride) · em vigor desde 2025-03-02
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…
Risks from Concomitant Use with Opioid Analgesics and Other Sedative Hypnotics Concomitant use of benzodiazepines, including Midazolam in 0.9% Sodium Chloride Injection, and opioids may result in profound sedation, respiratory depression, coma, and death.
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing information for complete boxed warning.
Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death.
Risks from Concomitant Use with Opioids, Other Sedative Hypnotics, or Other Central Nervous System Depressants Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
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