Therapeutic Classification: opioid addiction agents
Pharmacologic Classification: opioid agonists antagonists, opioid antagonists
REMS
Absorption: Buprenorphine: Well absorbed following SL administration; naloxone: Negligible absorption follows SL administration.
Distribution: Buprenorphine: Crosses the placenta; enters breast milk. CNS concentration is 15–25% of plasma.
Protein Binding: Buprenorphine: 96%.
Half-Life: Buprenorphine: 33 hr; Naloxone: 60–90 min (up to 3 hr in neonates).
Contraindicated in:
Use Cautiously in:
CV: QT interval prolongation, orthostatic hypotension
Derm: ↑sweating
Endo: ADRENAL INSUFFICIENCY
F and E: peripheral edema
GI: constipation, nausea, oral hypoesthesia, oral mucosal erythema, vomiting, glossodynia, hepatitis
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , physical dependence, psychological dependence, tolerance, withdrawal phenomenon
Drug-drug:
Drug-Natural Products:
Induction
Maintenance
Lab Test Considerations:
Can only be prescribed by clinicians who meet qualifying requirements, and who have notified the Secretary of Health and Human Services of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
NDC Code