Buprenorphine / Naloxone Dosage

This dosage information may not include all the information needed to use Buprenorphine / Naloxone safely and effectively. See additional information for Buprenorphine / Naloxone.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Opiate Dependence

Sublingual tablets:
Initial dose: 8 mg on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg.

The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.

For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.

Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.

The optimal method of tapering to discontinuation has not been reported.

Sublingual film: Initial dose: Buprenorphine/naloxone sublingual film should be used in patients who have been initially inducted using buprenorphine sublingual tablets. Buprenorphine/naloxone sublingual film is administered sublingually as a single daily dose. The sublingual film should be placed under the tongue. If an additional sublingual film is necessary to achieve the prescribed dose, place the additional sublingual film sublingually on the opposite side from the first film. The sublingual film should be placed in a manner to minimize overlapping as much as possible. The sublingual film must be kept under the tongue until the film is completely dissolved. Buprenorphine/naloxone sublingual film should not be chewed, swallowed, or moved after placement.
Maintenance: Buprenorphine/naloxone sublingual film is indicated for maintenance treatment. The recommended target dosage of buprenorphine/naloxone sublingual film is 16/4 mg buprenorphine/naloxone/day as a single daily dose.

The dosage of buprenorphine/naloxone sublingual film should be progressively adjusted in increments/decrements of 2/0.5 mg or 4/1 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.

The maintenance dose of buprenorphine/naloxone sublingual film is generally in the range of 4/1 mg buprenorphine/naloxone to 24/6 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage.

Renal Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with severe renal dysfunction (creatinine clearance 30 mL/min or less).

Liver Dose Adjustments

Dosage adjustments may be required in patients with moderate or severe hepatic impairment. Patients should be observed for symptoms of opioid withdrawal and adjustments made accordingly.

Precautions

Respiratory depression has been associated with buprenorphine, particularly after intravenous administration. Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants. Naloxone may not be effective in reversing buprenorphine-associated respiratory depression. In case of overdose, the primary concern is to establish adequate ventilation.

The naloxone component may produce severe withdrawal symptoms if buprenorphine-naloxone is injected by opioid-dependent individuals. Sublingual buprenorphine-naloxone may also cause withdrawal symptoms if taken before the opioid agonist effects have subsided.

Safety and effectiveness have not been established in pediatric patients under the age of 16 years.

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for sublingual buprenorphine-naloxone, buprenorphine-containing transmucosal products for opioid dependence, and extended-release and long-acting opioid analgesics. They include a medication guide and elements to assure safe use; the sublingual and transmucosal products also include an implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

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