Generic Name and Formulations:
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 0.7mg/0.18mg, 1.4mg/0.36mg, 2.9mg/0.71mg, 5.7mg/1.4mg, 8.6mg/2.1mg, 11.4mg/2.9mg; sublingual tabs; menthol-flavor.
Orexo U.S., Inc.
Indications for ZUBSOLV:
Treatment of opioid dependence, as part of a complete treatment plan including 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. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. ≥16yrs: Induction (under supervision): Day 1: Initially 1.4mg/0.36mg; give the remainder of the Day 1 dose up to 4.2mg/1.08mg in divided doses (1 or 2 tabs of 1.4mg/0.36mg) at 1.5–2hr intervals; up to max 5.7mg/1.4mg. Day 2: a single daily dose of up to 11.4mg/2.9mg. Dependent on heroin or short-acting opioids: Initiate induction with either Zubsolv or buprenorphine monotherapy (SL tabs). Dependent on methadone or long-acting opioids: Initiate induction with buprenorphine monotherapy (SL tabs), then transition to once-daily Zubsolv. Maintenance target dose: 11.4mg/2.9mg once daily; adjust in 1.4mg/0.36mg or 2.9mg/0.71mg increments/decrements to hold treatment level; usual range 2.9mg/0.71mg–17.2mg/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.
Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression). Increased cerebrospinal pressure (eg, head injury, intracranial lesions). Hepatic impairment (moderate): use with caution and monitor; (severe): avoid. Monitor hepatic function at baseline then periodically; evaluate if hepatic event is suspected. Myxedema. Hypothyroidism. Adrenal insufficiency. Coma. Toxic psychoses. CNS depression. Acute abdomen. Biliary tract dysfunction. Acute alcoholism. Delirium tremens. Kyphoscoliosis. Avoid abrupt cessation. Abuse potential. Opioid-naïve. Elderly. Debilitated. Unintentional pediatric exposure. Neonatal opioid withdrawal syndrome. Pregnancy, nursing mothers: see full labeling.
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): may need Zubsolv dose increase; monitor for opioid withdrawal. Concomitant NNRTIs (eg, efavirenz, delavirdine) or PIs (eg, 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. Monitor with concomitant muscle relaxants, diuretics, anticholinergics. Concomitant MAOIs (eg, phenelzine, tranylcypromine, linezolid) or within 14 days of discontinuation: not recommended. Risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, MAOIs); monitor.
Opioid (partial agonist-antagonist) + opioid antagonist.
Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, hypersensitivity.
SL tabs—3x10 (per carton)
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