Generic Name and Formulations:
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 2mg/0.5mg, 4mg/1mg, 8mg/2mg, 12mg/3mg; sublingual films; lime-flavor.
Indications for SUBOXONE:
Treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
Do not cut, chew or swallow. Give by sublingual (SL: under the tongue) or buccal (inside of cheek) administration. Place additional films sublingually or buccally on opposite side from the first film if needed; should minimize overlapping. Individualize based on type and degree of opioid dependence. ≥16yrs: Supervised induction (use SL route): Day 1: initially 2mg/0.5mg or 4mg/1mg; may increase in increments of buprenorphine 2mg or 4mg at 2-hr intervals, up to 8mg/2mg based on response; Day 2: a single dose up to 16mg/4mg. Dependent on methadone or long-acting opioids: Initiate induction with buprenorphine monotherapy (SL tabs). Dependent on heroin or short-acting opioids: Initiate induction with either Suboxone film or buprenorphine monotherapy (SL tabs). Maintenance phase: (target dose): 16mg/4mg once daily; adjust in 2mg/0.5mg or 4mg/1mg increments/decrements; (usual range): 4mg/1mg–24mg/6mg once daily. Switching between buprenorphine or buprenorphine/naloxone tabs and Suboxone films: start on same dosage as previously; may need dose adjustments between products; monitor for over- or under-dosing. Switching between various Suboxone film strengths: systemic exposures may be different; monitor for over- or under-dosing. 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 Suboxone 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.
Oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, withdrawal signs/symptoms, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, hepatitis, hypersensitivity reactions.
Renal, fecal (primary).
Films—30; Sublingual tabs—contact supplier