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ZUBSOLV
Addiction/dependence
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Drug Name:

ZUBSOLV CIII

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.

Company:
Orexo U.S., Inc.

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. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. 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) at least 6hrs after last opioid dose. 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 increments/decrements of 2.9mg/0.71mg or lower 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. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children:

Not established.

Warnings/Precautions:

Risk of significant respiratory depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Abuse potential (monitor). Accidental exposure may cause fatal overdose (esp. in children). Adrenal insufficiency. Obtain LFTs at baseline then monitor periodically; evaluate if hepatic event is suspected. Opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. CNS depression. Hepatic impairment (severe): not recommended; (moderate): avoid use for induction. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery: may need additional analgesia. Pregnancy/postpartum: may need dose adjustments; monitor closely for withdrawal. Potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.

Pharmacological Class:

Opioid (partial agonist-antagonist) + opioid antagonist.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); manage concomitant use as clinically appropriate and closely monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir): monitor and reduce Zubsolv dose, if needed. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Adverse Reactions:

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

REMS:

YES

How Supplied:

SL tabs—3x10 (per carton)

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