Monograph Details
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Pain & Pyrexia
> Narcotic analgesics
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DURAGESIC |
| Manufacturer |
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Janssen Pharmaceutica Products, LP |
| Legal Classification |
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CII |
| Pharmacological Class |
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Opioid. |
| Generic Name |
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Fentanyl 12 micrograms/hour, 25 micrograms/hour, 50 micrograms/hour, 75 micrograms/hour, 100 micrograms/hour; transdermal system. |
| Indications |
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Chronic pain in patients who require continuous opioid analgesia that cannot be managed by lesser means (eg, acetaminophen-opioid combinations, NSAIDs, or as-needed dosing with short-acting opioids). For use in opioid-tolerant patients only. |
| Children |
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Apply to clean, dry, intact, non-irradiated area on upper back; hold in place for 30 seconds; monitor adhesion; may be worn for 72 hours. <2yrs: not recommended. ≥2yrs: base initial dose on previous daily oral morphine dose: see literature. |
| Adults |
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Apply to clean, dry, intact, non-irradiated skin; hold in place for 30 seconds. May be worn for 72 hours. Conversion from other opiates: see literature. Patients <18 years who weigh <110 lbs: contact manufacturer. |
| Contraindications |
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See literature. Acute or post-op pain, or mild or intermittent pain that can be managed by lesser means. Do not use in patients who are non-opioid tolerant. Significant respiratory depression. Asthma. Paralytic ileus. Within 14 days of MAOIs. |
| Precautions |
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Respiratory depression. Chronic pulmonary disease. Head injuries. Increased intracranial pressure. Brain tumors. Bradycardia. Hepatic or renal impairment. Fever. Avoid external heat sources. Ambulatory patients. Biliary colic. Drug abusers. Clinicians should be fully experienced in use of continuous opioid analgesia. If adverse reactions occur, monitor for at least 24 hours after patch is removed. Monitor use in children. Cachexia. Elderly. Debilitated. Pregnancy (Cat.C). Labor and delivery, nursing mothers: not recommended. |
| Interactions |
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Potentiated by alcohol, other CNS depressants: reduce dose by at least 50% for one or both drugs. Potentiated by CYP3A4 inhibitors (eg, erythromycin, ketoconazole, ritonavir); monitor, may need to adjust dose. Antagonized by CYP3A4 inducers (eg, rifampin). |
| Adverse Reactions |
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Hypoventilation, hypo- or hypertension, GI upset, somnolence, apnea, dyspnea, dry mouth, headache, chest pain, arrhythmias, CNS depression or disturbances, urinary retention, pruritus, asthenia, local reactions. Children: also fever, insomnia. |
| How Supplied |
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Patch—5 |
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