Monograph Details
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Poisoning & Drug Dependence
> Addiction/dependence
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SUBOXONE 8mg/2mg |
| Manufacturer |
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Reckitt Benckiser Pharmaceuticals, Inc. |
| Legal Classification |
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CIII |
| Pharmacological Class |
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Opioid (partial agonist-antagonist) + opioid antagonist. |
| Generic Name |
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Buprenorphine (as HCl) 8mg, naloxone (as HCl dihydrate) 2mg; sublingual tabs; lemon-lime flavor. |
| Also |
• SUBOXONE 2mg/0.5mg
• SUBUTEX
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| Indications |
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Opioid dependence. |
| Children |
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≤16yrs: not recommended. |
| Adults |
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Dissolve under tongue; do not swallow tabs. Start when clear signs of withdrawal occur, at least 4 hours after last opioid use; individualize based on type and degree of opioid dependence. ≥16yrs: Supervised administration (induction phase): Subutex 8mg once on day 1 and Subutex 16mg once on day 2. Unsupervised administration (maintenance phase): target dose is Suboxone 16mg once daily; adjust in 2mg or 4mg increments; range 4–24mg once daily. |
| Precautions |
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Head injury. Increased intracranial pressure. Monitor hepatic function at baseline then periodically. Impaired pulmonary, renal, thyroid, or adrenocortical function. Coma. Toxic psychoses. CNS depression. Acute abdomen. Biliary tract dysfunction. GI or GU obstruction. Acute alcoholism. Delirium tremens. Kyphoscoliosis. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Potentiated by CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV protease inhibitors): may need buprenorphine dose adjustment. Monitor with CYP3A4 inducers (eg, phenobarbital, carbamazepine, phenytoin, rifampin). Avoid benzodiazepines (esp. intravenous), alcohol, other CNS depressants. |
| Adverse Reactions |
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Headache, withdrawal syndrome, pain, GI upset, insomnia, asthenia, sweating, orthostatic hypotension. |
| How Supplied |
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Tabs—30 |
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