Buprenorfina + nalokson i Naldemedyna: interakcja

Buprenorphine and naloxone sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9) ] .

Hypersensitivity to buprenorphine or naloxone.

Use in Patients with Impaired Hepatic Function Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

However, buprenorphine/naloxone products are not recommended for initiation of treatment (induction) in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal.

If a CYP3A4 inducer is discontinued, consider buprenorphine and naloxone sublingual tablet dosage reduction and monitor for signs of respiratory depression.

Intervention Avoid use of SYMPROIC with another opioid antagonist.

Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use ( 7 )

Opioid withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier.

Monitor symptoms of opioid withdrawal ( 5.2 )

Opioid Withdrawal Clusters of symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with SYMPROIC [see Adverse Reactions (6.1) ] .