Suboxone Generic Name & Formulations
Legal Class
CIII
General Description
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 2mg/0.5mg, 4mg/1mg, 8mg/2mg, 12mg/3mg; sublingual films; lime-flavor.
Pharmacological Class
Opioid (partial agonist-antagonist) + opioid antagonist.
See Also
How Supplied
Films—30; SL tabs—contact supplier
Manufacturer
Generic Availability
YES
Mechanism of Action
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Suboxone Indications
Indications
Treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
Suboxone Dosage and Administration
Adult
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. Rinse teeth/gums with water after film dissolves, and swallow. 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
Not established.
Administration
Do not cut, chew or swallow. 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. Do not move the film after placement. Gently rinse teeth and gums with water after film dissolves, and swallow. Wait at least 1hr before brushing teeth.
Nursing Considerations
Dissolve under tongue; do not cut, chew or swallow. Place additional films sublingually on opposite side from the first film if needed; should minimize overlapping. Do not move the film after placement.
Suboxone Contraindications
Not Applicable
Suboxone Boxed Warnings
Not Applicable
Suboxone Warnings/Precautions
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. Risk of QT prolongation (esp. in those with hypokalemia, bradycardia, recent conversion from atrial fibrillation, CHF, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, severe hypomagnesemia). Advise patients to obtain regular dental checkups during treatment. 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.
REMS
Suboxone Pharmacokinetics
Distribution
Plasma protein bound: ~96% (buprenorphine); ~45% (naloxone).
Elimination
Fecal (69%), renal (30%). Half-life: 24–42 hours (buprenorphine); 2–12 hours (naloxone).
Suboxone Interactions
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.
Suboxone Adverse Reactions
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, dental adverse events (eg, tooth fracture, tooth loss).
Suboxone Clinical Trials
See Literature
Suboxone Note
Not Applicable
Suboxone Patient Counseling
See Literature
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