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. ≥16yrs: Initiate with supervised administration. Patients dependent on heroin or other short-acting opioids (may be inducted with Bunavail or buprenorphine SL monotherapy): give first dose only if objective and clear signs of moderate opioid withdrawal appear, and >6hrs after last opioid dose. Induction on 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. Patients 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 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).
<16yrs: not established.
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. Myxedema. Hypothyroidism. CNS depression. Coma. Toxic psychoses. Prostatic hypertrophy. Urethral stricture. Acute alcoholism. Delirium tremens. Kyphoscoliosis. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Debilitated. Labor & delivery. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; 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.
Opioid (partial agonist-antagonist) + opioid antagonist.
Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain; respiratory depression, orthostatic hypotension, hepatitis, hypersensitivity reactions.
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