Generic Name and Formulations:
Buprenorphine 74.2mg (equivalent to 80mg of buprenorphine HCl); per implant; for subdermal use.
Indications for PROBUPHINE:
Maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of transmucosal buprenorphine-containing product (eg, ≤8mg/day Subutex, Suboxone, or generic equivalent), as part of a complete treatment plan to include counseling and psychosocial support.
See full labeling. For opioid-tolerant patients only. Insert 4 implants subdermally in the upper arm for 6 months, then remove. Examine insertion site 1 week after procedure for infection or impaired wound healing. After first 6-month cycle, implants may be replaced by new implants at time of removal in the contralateral arm, if continuing treatment; maintain on previous dose of transmucosal buprenorphine if not inserted on same day as removal.
<16yrs: not established.
Risk of serious complications (eg, nerve damage, migration, others) from insertion/removal of implants; see full labeling. Abuse potential (monitor). Risk of significant respiratory depression. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Accidental exposure may cause fatal overdose (esp. in children). Adrenal insufficiency. Obtain LFTs at baseline then monitor periodically; evaluate if hepatic event is suspected. Moderate or severe hepatic impairment; avoid. 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. History of keloid formation, connective tissue disease (eg, scleroderma), or recurrent MRSA infections. Avoid abrupt cessation. Opioid-naïve. Elderly. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery. Nursing mothers: monitor infants.
Potentiated by CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV protease inhibitors): monitor and may need dose adjustments or discontinuation. Antagonized by CYP3A4 inducers: monitor for opioid withdrawal and consider dose adjustments or discontinuation. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir): monitor. Risk of respiratory or CNS depression with concomitant opioid analgesics, general anesthetics, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics, alcohol, or other CNS depressants; caution and consider dose reduction of one or both drugs. Risk of serotonin syndrome with concomitant SSRIs, SNRIs, TCAs, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol, MAO inhibitors; monitor and discontinue if suspected.
Opioid (partial agonist-antagonist).
Implant-site pain/pruritus/erythema, headache, depression, constipation, nausea, vomiting, back pain, toothache, oropharyngeal pain; signs/symptoms of opioid withdrawal, insertion/removal complications (eg, neural/vascular injury, protrusion, expulsion, infection), orthostatic hypotension, hepatitis, hypersensitivity reactions.
Kit—1 (4 implants w. applicator)
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