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|Fentanyl Transdermal System |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Fentanyl Transdermal SystemPronouncation: (FEN-ta-nil)Class: Opioid analgesic Trade Names: Trade Names: Trade Names: Trade Names: Trade Names: Trade Names: Mechanism of ActionPharmacologyA potent opiate agonist that relieves pain by stimulating opiate receptors in CNS; also causes respiratory depression and peripheral vasodilation; inhibits intestinal peristalsis and sphincter of Oddi spasm; stimulates chemoreceptors that cause vomiting; increases bladder tone. PharmacokineticsAbsorptionT max is 24 to 72 h. C max is about 0.3 to 2.5 ng/mL (dose dependent). On-demand dosing with Ionsys results in absorption of a fentanyl 40 mcg dose by about 10 h posttreatment initiation; thereafter, fentanyl 40 mcg is delivered with each activation. When placed on the lower inner arm, fentanyl delivery from Ionsys is 20% lower than when applied on the upper outer arm or chest. DistributionVd is 6 L/kg. MetabolismPrimarily metabolized by CYP-450 3A4. EliminationMean t ½ is 17 h after removal ( Duragesic ). The mean t ½ of Ionsys is 11 h. Approximately 75% of an administered dose of fentanyl is excreted in the urine, primarily as metabolites. About 9% of the dose is recovered in the feces, mainly as metabolites. Special PopulationsElderlyReduced Cl and terminal t ½ is prolonged. Indications and UsageManagement of persistent moderate to severe chronic pain that requires continuous opioid administration for a prolonged period of time and that cannot be managed by other means ( Duragesic ); short-term management of acute postoperative pain in adult patients during hospitalization ( Ionsys ). ContraindicationsPatients who are not opioid-tolerant; management of acute pain or in patients requiring opioid analgesia for short periods of time; management of postoperative pain (including out-patient or day surgeries); management of mild pain; management of intermittent pain; situations of considerable respiratory depression, especially in unmonitored settings without resuscitative equipment; patients with acute or severe bronchial asthma; patient with paralytic ileus; hypersensitivity to fentanyl or any component of the product; hypersensitivity to cetylpyridium chloride (eg, Cepacol ) ( Ionsys ). Dosage and AdministrationPersistent Moderate to Severe Chronic Pain ( Duragesic )Adults and Children 2 yr of age and older Transdermal Calculate dose based on previous day"s opiate requirements using manufacturer"s conversion charts. Max pain relief does not occur until 24 h or more after application; a short-acting opiate may be needed for breakthrough pain. Initial dose can be increased after 3 days. Further dosage increases should occur at 6-day intervals at least. Replace patches q 3 days; some patients require new patch q 2 days. Acute Postoperative Pain ( Ionsys )Adults Transdermal Titrate patient to comfort before initiating Ionsys . Ionsys provides a fentanyl 40 mcg dose per on-demand activation. Each dose is delivered over a 10-min period. To activate administration, patient must press the button twice firmly within 3 sec. A max of six 40 mcg doses can be administered by Ionsys . The max amount of fentanyl that can be administered from a single Ionsys system over 24 h is 3.2 mg. General Advice
Storage/StabilityStore Duragesic patches in foil packets at or below 77°F. Apply immediately after removal from sealed package. Do not use if seal is broken or the patch is damaged or altered in any way. Store Ionsys at 59° to 86°F. Apply to skin immediately after removal from sealed package. Do not use if foil pouch is broken. Drug InteractionsAlcohol, drugs of abusePossible additive CNS depressant effects. AmiodaroneProfound bradycardia, sinus arrest, and hypotension may occur. Barbiturate anesthetics, other CNS depressantsMay have additive effects. Reduce dosage of 1 or both agents. MAOIsNot recommended for use in patients who have received MAOIs within 14 days. Potent CYP3A4 inhibitors (eg, clarithromycin, diltiazem, erythromycin, ketoconazole, nefazodone, protease inhibitors [eg, ritonavir]), other CNS depressants (eg, alcohol, barbiturates, benzodiazepines, general anesthetics, other opioids, phenothiazines, sedating antihistamines, sedatives/hypnotics, skeletal muscle relaxants, tranquilizers)Increased depressant effects; hypoventilation, hypotension, profound sedation, and life-threatening respiratory depression may occur. Laboratory Test InteractionsNone well documented. Adverse ReactionsCardiovascularDuragesic AdultsArrhythmias, chest pain (at least 1%); tachycardia (postmarketing). ChildrenHypertension, syncope, tachycardia (at least 1%). IonsysHypotension (2%); hypertension, tachycardia (1% to less than 10%). CNSDuragesic AdultsFatigue, headache (3% to 10%). ChildrenAsthenia, headache, insomnia, nervousness, somnolence (3% to 10%); agitation, anxiety, confusion, convulsions, depression, dizziness, hallucinations, paranoid reaction, speech disorder, stupor, tremor (at least 10%). IonsysHeadache (9%); dizziness, insomnia (3%); anxiety, hypertonia, somnolence (1% to less than 10%). DermatologicDuragesic AdultsSweating (at least 10%); pruritus (3% to 10%); rash (at least 1%). ChildrenApplication-site reaction, pruritus (3% to 10%); erythematous rash, increased sweating, localized skin reaction, rash (at least 1%). EENTDuragesic AdultsBlurred vision (postmarketing). ChildrenRhinitis (at least 10%). IonsysPharyngitis (1% to less than 10%). GIDuragesic AdultsConstipation, dry mouth, nausea, vomiting (at least 10%); anorexia, diarrhea, dyspepsia (3% to 10%); flatulence (at least 1%). ChildrenNausea, vomiting (at least 10%); constipation (3% to 10%); diarrhea, dry mouth, (at least 1%). IonsysNausea (39%); vomiting (12%); constipation, dyspepsia, flatulence, ileus (1% to less than 10%). GenitourinaryDuragesic AdultsUrinary retention (3% to 10%); micturition disorder (at least 1%); anorgasmia, decreased libido, ejaculatory difficulty (postmarketing). ChildrenUrinary retention (at least 1%). IonsysUrinary retention (3%). Hematologic-LymphaticIonsysAnemia (3%). LocalDuragesic AdultsApplication-site reaction including edema, erythema, itching, papules (at least 1%). IonsysApplication-site erythema (14%); pruritus (6%); application-site edema, itching, and vesicles, sweating, wound oozing/bleeding (1% to less than 10%). MetabolicDuragesic AdultsWeight loss (postmarketing). Metabolic-NutritionalIonsysHypokalemia (1% to less than 10%). MusculoskeletalDuragesic AdultsBack pain, rigors (at least 1%). IonsysBack pain (2%). RespiratoryDuragesic AdultsApnea, dyspnea, hypoventilation (3% to 10%); bronchitis, hiccups, rhinitis, sinusitis, upper respiratory tract infection (at least 1%). ChildrenCoughing, dyspnea, respiratory depression (at least 10%). IonsysHypoxia (1% to less than 10%). MiscellaneousDuragesic AdultsAbdominal pain (3% to 10%); accidental injury, fever, influenza-like symptoms (at least 1%); edema (postmarketing). ChildrenPain (3% to 10%); abdominal pain, allergic reaction, fever, flushing (at least 1%). IonsysFever (9%); abdominal pain, extremity pain, pain (1% to less than 10%). Precautions
PregnancyCategory C . LactationExcreted in breast milk. ChildrenSafety and efficacy not established in children younger than 2 yr of age ( Duragesic ). Safety and efficacy not established in patients younger than 18 yr of age ( Ionsys ). Renal FunctionFentanyl is renally excreted. Use with caution. Hepatic FunctionFentanyl is hepatically metabolized. Use with caution. Special Risk PatientsUse with caution in elderly, debilitated, or cachetic patients or patients with myxedema, acute alcoholism, acute abdominal conditions, biliary tract disease (including acute pancreatitis), ulcerative colitis, head injury or increased intracranial pressure, brain tumors, supraventricular tachycardia, depleted blood volume, or circulatory shock. Hazardous TasksMay impair physical or mental abilities required to perform potentially dangerous tasks. Cardiac diseaseMay cause bradycardia. Use with caution in patients with bradyarrhythmias. Drug dependenceFentanyl has abuse potential. Exposure to external heatDirect contact with heating pads, electric blankets, saunas, or hot tubs could increase fentanyl absorption. FeverMay increase absorption of fentanyl; monitor for adverse reactions. Respiratory depressionSerious or life-threatening hypoventilation may occur, especially during the initial 24 to 72 h and following increases in dose. Use with extreme caution in patients with COPD or cor pulmonale, or in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. ToleranceMay occur. Topical skin reactionsAfter removal of Ionsys , topical skin reactions (erythema, sweating, vesicles, papules/pustules) may occur at the application site. OverdosageSymptomsCardiopulmonary arrest, circulatory collapse, CNS depression, death, hypoventilation, miosis, respiratory depression, seizures. Patient Information
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