Generic Name and Formulations:
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 1.4mg/0.36mg, 5.7mg/1.4mg; sublingual tabs; menthol-flavor.
Orexo U.S., Inc.
Maintenance treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
Dissolve under tongue; do not cut, chew or swallow. Place additional tabs sublingually in different places under the tongue at the same time if needed. ≥16yrs: Initiate after supervised induction with buprenorphine sublingual tabs. Maintenance target dose: 11.4mg/2.8mg once daily; adjust in 1.4mg/0.36mg or 2.8mg/0.72mg increments; usual range 2.8mg/0.72mg–17.1mg/4.2mg once daily. Switching between Zubsolv and other buprenorphine/naloxone products: may need dose adjustments; monitor for over- or under-dosing. Switching between Suboxone SL tabs and Zubsolv: see full labeling.
<16yrs: not established.
Opioid (partial agonist-antagonist) + opioid antagonist.
Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression). Head injury. Increased intracranial pressure. Monitor hepatic function at baseline then periodically; evaluate if hepatic event is suspected. Myxedema. Hypothyroidism. Adrenal cortical insufficiency. Coma. Toxic psychoses. CNS depression. Acute abdomen. Biliary tract dysfunction. GI or GU obstruction. Acute alcoholism. Delirium tremens. Kyphoscoliosis. Avoid abrupt cessation. Abuse potential. Opioid-naïve. Elderly. Debilitated. Unintentional pediatric exposure. Neonatal withdrawal. Pregnancy (Cat.C). Nursing mothers: not recommended.
Potentiated by CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV protease inhibitors): monitor and may need dose adjustments. Concomitant CYP3A4 inducers (eg, efavirenz, nevirapine, etravirine, phenobarbital, carbamazepine, phenytoin, rifampicin): monitor for opioid withdrawal. Concomitant NNRTIs (eg, efavirenz, delaviridine) or atazanavir with/without ritonavir: monitor and reduce buprenorphine dose, if needed. Increased CNS depression with concomitant opioid analgesics, general anesthetics, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics, or other CNS depressants (eg, alcohol); caution and consider dose reduction of both agents.
Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, anaphylactic shock.
SL tabs—3x10 (per carton)