Butrans Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Butrans Indications
Indications
Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration); increased risks of overdose and death with extended-release/long-acting opioid formulations, reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.
Butrans Dosage and Administration
Adult
Children
Administration
Nursing Considerations
Butrans Contraindications
Contraindications
Butrans Boxed Warnings
Boxed Warning
Serious and life-threatening risks from use of Butrans: Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental exposure; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS).
Butrans Warnings/Precautions
Warnings/Precautions
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Not for use in the management of addictive disorders. Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. 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). Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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 (monitor infants if exposed).
REMS
Butrans Pharmacokinetics
Absorption
Steady state achieved during the first application by Day 3. Absolute bioavailability following a 7-day application is ~15% for all doses.
Distribution
Volume of distribution: ~430 L. Plasma protein bound: 96%.
Elimination
Hepatic, biliary, renal. Half-life: ~26 hours (after patch removal). Total clearance: ~55 L/hour.
Butrans Interactions
Interactions
Butrans Adverse Reactions
Adverse Reactions
Nausea, headache, application site reactions (pruritus, erythema, rash; discontinue if severe), dizziness, constipation, somnolence, vomiting, dry mouth; respiratory depression, orthostatic hypotension, syncope, hypersensitivity reactions, OIH and allodynia.
Butrans Clinical Trials
See Literature
Butrans Note
Not Applicable
Butrans Patient Counseling
See Literature
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