Addiction/dependence:

Indications for SUBOXONE:

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

Adult Dosage:

Do not cut, chew or swallow. Avoid food or drinks until film dissolves. Give by sublingual (SL: under the tongue) or buccal (inside of cheek) administration. Place additional films sublingually or buccally on opposite side from the first film if needed; should minimize overlapping. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. Supervised induction (use SL route): Day 1: initially 2mg/0.5mg or 4mg/1mg; may increase in increments of buprenorphine 2mg or 4mg at 2-hr intervals, up to 8mg/2mg based on response; Day 2: a single dose up to 16mg/4mg. Dependent on heroin or short-acting opioids: initiate induction with either Suboxone film or buprenorphine monotherapy (SL tabs) at least 6hrs after last opioid dose. Dependent on methadone or long-acting opioids: initiate buprenorphine monotherapy (SL tabs) for induction, then transition to once daily Suboxone. Maintenance phase: (target dose): 16mg/4mg once daily; adjust in 2mg/0.5mg or 4mg/1mg increments/decrements; (usual range): 4mg/1mg–24mg/6mg once daily. Switching between buprenorphine or buprenorphine/naloxone tabs and Suboxone films: start on same dosage as previously; may need dose adjustments between products; monitor for over- or under-dosing. Switching between various Suboxone film strengths: systemic exposures may be different; monitor for over- or under-dosing. Hepatic impairment (severe): not recommended; (moderate): avoid use for induction. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children Dosage:

Not established.

SUBOXONE Warnings/Precautions:

Potential risk for opioid overdose; strongly consider prescribing naloxone when initiating and renewing therapy. Consider prescribing naloxone if the patient has household members (eg, children) or other close contacts at risk of accidental ingestion or overdose. Abuse potential (monitor). Risk of significant respiratory depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Unintentional pediatric exposure. 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. Moderate and severe hepatic impairment. 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.

SUBOXONE Classification:

Opioid (partial agonist-antagonist) + opioid antagonist.

SUBOXONE 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; strongly consider prescribing naloxone if concomitant use is warranted. 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, cyclobenzaprine, metaxalone, 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 buprenorphine/naloxone 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:

Oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, withdrawal signs/symptoms, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, hepatitis, hypersensitivity reactions.

REMS:

YES

Generic Drug Availability:

YES

How Supplied:

Films—30; SL tabs—contact supplier