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. Avoid food or drinks until tab dissolves. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. 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).
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. CNS depression. Moderate and severe hepatic impairment. 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.
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 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; SL tabs—contact supplier