Buprenorphine Sublingual Tablets CIII

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Buprenorphine Sublingual Tablets

Addiction/dependence
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Generic Name and Formulations:

Buprenorphine (as HCl) 2mg, 8mg; sublingual tabs.

Select therapeutic use:

Indications for Buprenorphine Sublingual Tablets:

Treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.

Adult:

Dissolve under tongue; do not swallow tabs. Start when clear signs of withdrawal occur, at least 4 hours after last opioid use; individualize based on type and degree of opioid dependence. ≥16yrs: Supervised induction: 8mg once on Day 1 and 16mg once on Day 2. Maintenance phase: use buprenorphine/naloxone sublingual tabs at the same buprenorphine dose as Day 2; if intolerant to naloxone, may adjust buprenorphine by 2mg or 4mg increments/decrements; (usual range): 4–24mg once daily. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children:

<16yrs: not established.

Warnings/Precautions:

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.

Interactions:

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.

See Also:

SUBOXONE

Pharmacological Class:

Opioid (partial agonist-antagonist).

Adverse Reactions:

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.

Note:

Formerly known under the brand name Subutex.

Metabolism:

Hepatic.

Elimination:

Renal, fecal (primary).

REMS:

YES

Generic Availability:

NO

How Supplied:

Films—30; Sublingual tabs—contact supplier