Buprenorphine Sublingual Tablets CIII
Generic Name and Formulations:
Buprenorphine (as HCl) 2mg, 8mg; sublingual tabs.
Various generic manufacturers
Indications for Buprenorphine Sublingual Tablets:
Treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
Dissolve under tongue; do not swallow tabs. Start when clear signs of withdrawal occur. Individualize based on type and degree of opioid dependence. ≥16yrs: Supervised induction: 8mg once on Day 1 and 16mg once on Day 2. Dependent on heroin or short-acting opioids: initiate induction at least 4hrs after last opioid use. Dependent on methadone or long-acting opioids: initiate induction at least 24hrs after last opioid use. Maintenance phase: use buprenorphine/naloxone sublingual films at the same buprenorphine dose as Day 2; if intolerant to naloxone, may adjust buprenorphine by 2mg or 4mg increments/decrements to hold treatment level; (target dose): 16mg once daily; (usual range): 4–24mg once daily. Hepatic impairment (severe): reduce dose by ½ and monitor; (moderate): caution and monitor. 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. 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. Moderate and severe hepatic impairment. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Debilitated. Labor & delivery: maintenance therapy 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.
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).
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.
Formerly known under the brand name Subutex.
Renal, fecal (primary).
Films—30; Sublingual tabs—contact supplier
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