Generic Name and Formulations:
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 2.1mg/0.3mg, 4.2mg/0.7mg, 6.3mg/1mg; buccal films; citrus flavor.
Indications for BUNAVAIL:
Treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
Dissolve against inside of cheek; do not cut, chew or swallow. Avoid food or drinks until film dissolves. Place additional films on the inside of other cheek if needed; max 2 films can be applied to the inside of one cheek at a time. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. Induction (under supervision): Day 1: initially 2.1mg/0.3mg; repeat after approx. 2hrs to a total dose of 4.2mg/0.7mg based on response; Day 2: single daily dose of up to 8.4mg/1.4mg. Dependent on heroin or other short-acting opioids: initiate induction with either Bunavail or buprenorphine SL monotherapy at least 6hrs after last opioid dose. Dependent on methadone or other long-acting opioids: use buprenorphine monotherapy for induction, then transition to once daily Bunavail. Maintenance (Day 3 onwards): target dose of 8.4mg/1.4mg once daily; adjust in 2.1mg/0.3mg increments/decrements; usual range 2.1mg/0.3mg–12.6mg/2.1mg once daily. Switching between Bunavail and other buprenorphine/naloxone products: may need dose adjustments; monitor for over- or under-dosing. Switching between Suboxone SL tabs and Bunavail: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).
Risk of significant respiratory depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Abuse potential (monitor). Accidental exposure may cause fatal overdose (esp. in children). Adrenal insufficiency. Obtain LFTs at baseline then monitor periodically; evaluate if hepatic event is suspected. Hepatic impairment (severe): not recommended; (moderate): avoid use for induction. Opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. CNS depression. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery: may need additional analgesia. Pregnancy/postpartum: may need dose adjustments; monitor closely for withdrawal. Potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.
Opioid (partial agonist-antagonist) + opioid antagonist.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); manage concomitant use as clinically appropriate and closely monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir): monitor and reduce Bunavail dose, if needed. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, hepatitis, hypersensitivity reactions.
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