ZUBSOLV CIII

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ZUBSOLV

Addiction/dependence
Only 4 drugs may be compared at once

Generic Name and Formulations:

Buprenorphine (as HCl), naloxone (as HCl dihydrate); 1.4mg/0.36mg, 2.9mg/0.71mg, 5.7mg/1.4mg, 8.6mg/2.1mg, 11.4mg/2.9mg; sublingual tabs; menthol-flavor.

Company:

Orexo U.S., Inc.

Select therapeutic use:

Indications for ZUBSOLV:

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

Adult:

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: Induction (under supervision): Day 1: initially 1.4mg/0.36mg SL tab; 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: up to 11.4mg/2.9mg SL tab once daily. 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.

Children:

<16yrs: not established.

Warnings/Precautions:

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.

Interactions:

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.

Pharmacological Class:

Opioid (partial agonist-antagonist) + opioid antagonist.

Adverse Reactions:

Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, anaphylactic shock.

REMS:

YES

How Supplied:

SL tabs—3x10 (per carton)

ZUBSOLV 5.7mg/1.4mg sublinguals (Qty:2)

appx. price $23.00