Buprenorphine Transdermal

Buprenorphine Transdermal is a prescription medication used in the management of severe pain.

• Buprenorphine Transdermal is available under the following different brand names: Butrans

Adult dosage

Transdermal patch: Schedule III

• 5mcg/hr
• 7.5mcg/hr
• 10mcg/hr
• 15mcg/hr
• 20mcg/hr

Chronic Severe Pain

Adult dosage

• Each patch is worn for 7 days (except during titration)
• Opioid-naïve: Initiate with 5 mcg/hr patch; may supplement with prompt-acting opioid and nonopioid analgesic for break-through pain
• Do not increase patch until the patient has been exposed continually to the previous dose for 72 hours
• Based on the requirement for supplemental short-acting analgesics, upward titration may be instituted with at a minimum interval of 72 hours
• Do not exceed the dose of one 20 mcg/hr transdermal system (risk of QT prolongation with higher doses)
• Conversion from other opioids
  • Oral morphine equivalent  to less than 30 mg/day: Initiate with 5 mcg/hr patch
  • Oral morphine equivalent 30-80 mg/day: Initiate with 10 mcg/hr patch
  • Use caution when prescribing to opioid-experienced patients requiring high doses of opioids (i.e., above 80 mg/day oral morphine equivalent); buprenorphine transdermal 20 mcg/hr may not provide adequate analgesia for patients previously on high-dose opioids
• Opioid-tolerant definition
  • Use of higher starting doses in patients who are not opioid-tolerant may cause fatal respiratory depression
  • Opioid-tolerant patients are those receiving, for 1 week or longer, at least 60 mg/day orally morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day orally oxycodone, 8 mg/day orally hydromorphone, 25 mg/day orally oxymorphone, or an equianalgesic dose of another opioid

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Buprenorphine transdermal include:

• constipation,
• nausea,
• vomiting,
• headache,
• dizziness,
• drowsiness,
• tiredness, and
• redness, itching, or rash where the patch was worn

Serious side effects of Buprenorphine transdermal include:

• weak or shallow breathing,
• deep sighs,
• new or unusual snoring,
• breathing that stops during sleep,
• chest pain,
• fast heart rate,
• seizure,
• lightheadedness,
• blisters, swelling, severe irritation at the patch site,
• nausea,
• vomiting,
• loss of appetite,
• dizziness,
• feeling weak or tired,
• upper stomach pain,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• agitation,
• hallucination,
• fever,
• sweating,
• shivering,
• muscle stiffness,
• twitching,
• loss of coordination, and
• diarrhea

Rare side effects of Buprenorphine transdermal include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Buprenorphine transdermal has no noted severe interactions with any other drugs.
• Buprenorphine transdermal has no noted serious interactions with any other drugs.
• Buprenorphine transdermal has no noted moderate interactions with any other drugs.
• Buprenorphine transdermal has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Significant respiratory depression
• Severe bronchial asthma
• Paralytic ileus
• Management of acute pain or opioid analgesia required for a short period
• Management of postoperative pain, including use after outpatient or day surgeries
• Management of mild pain
• Management of intermittent pain (not for PRN use)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Buprenorphine transdermal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Buprenorphine transdermal?”

Cautions

• Respiratory depression is the main hazard; may occur more frequently in elderly or debilitated patients, or conditions associated with hypoxia or hypercapnia (even moderate therapeutic doses)
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases the risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper
• CNS depression: May cause somnolence, dizziness, altered consciousness (including coma)
• Coadministration with alcohol, other CNS depressants, and illicit drugs may cause hypotension, profound sedation, and coma or respiratory depression
• QTc prolongation observed in healthy individuals at 40 mcg/hr; avoid in patients with a history of Long QT Syndrome or coadministration with Class IA (eg, quinidine, procainamide, disopyramide) or Class III (eg, sotalol, amiodarone, dofetilide) antiarrhythmics
• Head injury: Respiratory depressant effects of opioids may include carbon dioxide retention and lead to elevated CSF pressure
• Hypotensive effects: Can cause severe hypotension; caution with depleted blood volume or coadministration of drugs that affect vasomotor tone (eg, phenothiazines), vasodilators, or antihypertensives
• Misuse, abuse, diversion: Partial agonist at the mu-opioid receptor and Schedule III controlled opioids expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Black Box Warnings)
• Serious, life-threatening, or fatal respiratory depression was reported (see Black Box Warnings)
• Accidental exposure was reported, including fatalities (see Black Box Warnings)
• Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Black Box Warnings)
• Do not abruptly discontinue buprenorphine in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain
• Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase the risk for respiratory depression, profound sedation, and hypotension
• Hepatoxicity: Although not observed in buprenorphine transdermal chronic pain clinical trials, cases of cytolytic hepatitis and hepatitis with jaundice were observed in individuals receiving buprenorphine SL for opioid dependence treatment
• Fever: If fever or increased core body temperature occurs following strenuous exertion, monitor for increased opioid adverse effects; adjust the dose if necessary
• Similar to other opioids, may aggravate seizure disorders by lowering the seizure threshold
• Special risk groups may experience increased adverse reactions; caution with alcoholism, delirium tremens, adrenocortical insufficiency, CNS depression, debilitation, kyphoscoliosis associated with respiratory compromise, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, severe impairment of hepatic, pulmonary or renal function, and toxic psychosis
• May cause sphincter of Oddi spasm and aggravate abdominal conditions, including ileus
• Not recommended for use within 14 days of MAO inhibitors; severe and unpredictable potentiation by MAO inhibitors reported
• Opioid analgesic risk evaluation and mitigation strategy (REMS)
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products
  • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed; Use the following link to obtain the Patient Counseling Guide (PCG): www.fda.gov/OpioidAnalgesicREMSPCG
  • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them
  • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities
  • To obtain further information on opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com; the FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risk during pregnancy
• Opioids cross the placenta and may produce respiratory depression and psychophysiological effects in neonates; not recommended for use in women immediately before and during labor, when the use of shorter-acting analgesics or other analgesic techniques are more appropriate
• Neonates whose mothers have been taking opioids chronically may also exhibit withdrawal signs, either at birth and/or in the nursery because they have developed physical dependence; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts.
• Lactation
  • Detected in low concentrations in human milk; breastfeeding not advised.