Suboxone (buprenorphine and naloxone)

SUBOXONE (buprenorphine and naloxone) – a sublingual tablet containing buprenorphine and naloxone commonly used to treat opiate dependence. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.

FDA approved uses: Suboxone is indicated for the maintenance treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act.

Available dosage forms: Sublingual Tablets – 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone.

Usual dosage: The recommended daily dose for maintenance is 16/4 mg, administered sublingually as a single daily dose.

Contraindications: Hypersensitivity to buprenorphine or naloxone.
Special warnings: Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants, SUBOXONE sublingual tablet, or both in situations of concomitant prescription. Store SUBOXONE sublingual tablet safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.

Adverse reactions (side effects) of these medications: The most common side effects of Suboxone include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. Other adverse events reported include asthenia, infection, abdominal pain, back pain, vasodilation, diarrhea, insomnia, rhinitis, sweating, chills, flu syndrome. headache, anxiety, depression, cough, pharyngitis, rhinitis, and runny eyes.

Common drug interactions: The concomitant use of SUBOXONE sublingual tablet with CYP3A4 inhibitors (e.g., azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, and HIV protease inhibitors) should be monitored and may require dose-reduction of one or both agents. Patients receiving SUBOXONE sublingual tablets be monitored for signs and symptoms of opioid withdrawal if inducers of CYP3A4 (e.g., efavirenz, phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered. It is recommended that patients who are on chronic buprenorphine treatment have their dose monitored if NNRTIs are added to their treatment regimen. Atazanavir and atazanavir/ritonavir resulted in elevated levels of buprenorphine and norbuprenorphine and patients in one study reported increased sedation. Symptoms of opioid excess have been found in post-marketing reports of patients receiving buprenorphine and atazanavir with and without ritonavir concomitantly. Monitoring of patients taking buprenorphine and atazanavir with and without ritonavir is recommended, and dose reduction of buprenorphine may be warranted. SUBOXONE sublingual tablets should be prescribed with caution to patients taking benzodiazepines or other drugs that act on the CNS, as coma and death have been reported.

Special instructions for patients: Take this medication exactly as directed by physician. Read the full Patient Medication Guide prior to starting your first prescription, and with each refill. SUBOXONE can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if you feel faint, dizzy, or confused or if your breathing gets much slower than is normal for you. Keep out of sight of and reach of children.

Full prescribing information may be found at the manufacturer‘s official website Suboxone.com or at the U.S. Food and Drug Administration’s website at Suboxone Info at Drugs@FDA

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