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BUTRANS
Narcotic analgesics
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Drug Name:

BUTRANS CIII

Generic Name and Formulations:
Buprenorphine 5mcg/hr, 7.5mcg/hr, 10mcg/hr, 15mcg/hr, 20mcg/hr; transdermal patch.

Company:
Purdue Pharma L.P.

Therapeutic Use:

Indications for BUTRANS:

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

Limitations Of use:

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Adult:

Use lowest effective dose for shortest duration. Apply one patch to clean, dry, hairless, intact skin on upper outer arm, upper chest, upper back, or side of chest every 7 days. Cleanse application site with water only. Do not cut patch. Rotate sites (allow ≥21 days before reapplication to same site). Individualize. ≥18yrs: Opioid-naive, or oral morphine equivalents <30mg/day: one 5mcg/hr patch. Doses of 7.5, 10, 15, 20mcg/hr: for opioid-tolerant patients only. Conversion from oral morphine equivalents 30–80mg/day: taper current opioids for up to 7 days to ≤30mg/day oral morphine equivalents before starting, then initiate with Butrans 10mcg/hr patch; may use short-acting analgesics until Butrans efficacy is attained. Conversion from oral morphine equivalents >80mg/day: consider alternative. For all: may adjust dose every 3 days in increments of 5mcg/hr, 7.5mcg/hr or 10mcg/hr; max 2 patches of each strength per titration. Max one 20mcg/hr patch per week. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually every 7 days.

Children:

<18yrs: not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Warnings/Precautions:

Not for use in the management of addictive disorders. Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Increased risk of QT prolongation with doses >20mcg/hr; avoid with history of long QT syndrome. Hypokalemia. Unstable cardiac disease (eg, unstable atrial fibrillation, symptomatic bradycardia, unstable CHF, active MI). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Fever. Drug abusers. Severe hepatic impairment: consider alternative. If at risk for hepatotoxicity (eg, history of alcohol or IV drug abuse, liver disease); obtain baseline liver enzyme levels and monitor periodically. Avoid external heat (eg, thermal wraps, sunlamps); risk of overdose. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. Avoid concomitant Class 1A (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmics (eg, sotalol, amiodarone, dofetilide). 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. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. 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.

Pharmacological Class:

Opioid (partial agonist-antagonist).

Adverse Reactions:

Nausea, headache, application site reactions (pruritus, erythema, rash; discontinue if severe), dizziness, constipation, somnolence, vomiting, dry mouth; respiratory depression, severe hypotension, syncope, hypersensitivity reactions.

Metabolism:

Hepatic (CYP3A4); 96% protein bound.

Elimination:

Biliary, fecal, renal.

REMS:

YES

Generic Availability:

NO

How Supplied:

Patch—4 (w. disposal units)

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