Generic Name and Formulations:
Fentanyl 12mcg/hr, 25mcg/hr, 50mcg/hr, 75mcg/hr, 100mcg/hr; transdermal system.
Janssen Pharmaceuticals, Inc.
Indications for DURAGESIC:
Management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate.
Limitations Of use:
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. Not for use as an as-needed (prn) analgesic.
Adults and Children:
Use lowest effective dose for shortest duration. Apply to clean, dry, intact, non-irradiated skin (upper back preferred for children; monitor adhesion); hold in place for 30 seconds; may be worn for 72hrs. Cleanse application site with water only. Do not cut patch. <2yrs: not established. ≥2yrs: Individualize. Base initial dose on previous daily oral opioid (eg, morphine) dose; see full labeling for conversion from other opioids. Mild to moderate hepatic or renal impairment: initiate at ½ the usual dose. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). If adverse reactions occur, monitor for ≥24hrs after patch is removed. Withdraw gradually.
Opioid non-tolerant patients. Acute or post-op pain, or mild or intermittent pain that can be managed by lesser means. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental exposure. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Risks of increased fentanyl absorption with application of external heat. Risks from concomitant use with benzodiazepines or other CNS depressants.
Abuse potential (monitor). 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. Severe hepatic or renal impairment: not recommended. Avoid external heat sources. Fever. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Bradyarrhythmias. Biliary tract disease. Acute pancreatitis. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Dispose properly. Elderly. Cachectic. Debilitated. Children: monitor. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
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. 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, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, anorexia, headache, diarrhea; respiratory depression, severe hypotension, syncope.
Renal (primarily), fecal.
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