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 BRAND NAMES
 MECHANISM OF ACTION
Fentanyl is a synthetic opioid receptor agonist which interacts primarily with the mu-opioid receptor. The low molecular weight, high potency and lipid solubility of fentanyl make it suitable for delivery by the transdermal therapeutic system.
Fentanyl exerts its principal pharmacologic effects on the central nervous system. In addition to analgesia, alterations in mood, euphoria, dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.
Analgesic blood concentrations of fentanyl may cause also nausea and vomiting directly by stimulating the chemoreceptor trigger zone.
Fentanyl (Transdermal) is indicated for the management of persistent, moderate to severe chronic pain in opioid‑tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (e.g. in terminally cancer patients).
Fentanyl (Transdermal) is not intended for use as an as-needed analgesic.
Dosage should be adjusted according to the severity of the pain and the response of the patient. Each transdermal system is intended to be worn for 72 hours.
When Fentanyl (Transdermal) is no longer needed by the patient, taper the dose as part of a pain management plan
- Opioid non-tolerant patients.
- Impaired pulmonary function.
- Paralytic ileus.
- Known hypersensitivity to fentanyl or any of the components of the transdermal system.
 WARNINGS AND PRECAUTIONS
- Fentanyl (Transdermal) can be abused. Use caution when prescribing if there is an increased risk of misuse, abuse, or diversion.
- Fatal respiratory depression can occur. Monitor patients accordingly. Use with extreme caution in patients at risk of respiratory depression.
- Accidental exposure of Fentanyl (Transdermal), especially in children, can result in a fatal overdose of fentanyl.
- Use Fentanyl (Transdermal) with extreme caution in patients susceptible to intracranial effects of CO2 retention.
- Fentanyl (Transdermal) may have additive effects when used in conjunction with other CNS depressants, alcohol, and drugs of abuse.
- Use of Fentanyl (Transdermal) with a CYP3A4 inhibitor may result in an increase in fentanyl plasma concentrations. Monitor patients accordingly and adjust dosage if necessary.
- Fentanyl (Transdermal) may produce bradycardia. Administer with caution to patients with bradyarrhythmias.
- Use with caution in patients with pancreatic/biliary disease.
- Avoid exposing the Fentanyl (Transdermal) application site and surrounding area to direct external heat sources. temperature dependent increases in fentanyl release from the system may result in overdose and death.
- Fentanyl is metabolized mainly via the human cytochrome CYP3A4, therefore potential interactions may occur when it is given concurrently with agents that affect CYP3A4 activity. Adjust dosage if necessary.
- The concomitant use of Fentanyl with CYP3A4 inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, diltiazem, erythromycin,fluconazole, grapefruit juice or verapamil) may result in a potentially dangerous increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
- The concomitant use of Fentanyl with CYP3A4 inducers (e.g., barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampicin, St. John's wort, or troglitazone) may result in a decrease in fentanyl plasma concentrations, which could decrease its efficacy.
- Use CNS Depressants including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages with caution and in reduced dosage in patients who are receiving Fentanyl (CNS Depressants may produce increased depressant effects e.g., hypoventilation, hypotension, and profound sedation).
- Avoid Fentanyl (Transdermal) in patients taking a monoamine oxidase (MAO) inhibitor or within 14 days of stopping such treatment
 PREGNANCY AND LACTATION
- Pregnancy Category C (US): Based on animal data, may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Nursing Mothers: Fentanyl is excreted in human milk; Breast-feeding is not advised in mothers treated with Fentanyl, because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using Fentanyl.
 SIDE EFFECTS
Most common adverse reactions: nausea, vomiting, somnolence, dizziness, insomnia, constipation, headache, diarrhea, hyperhidrosis, fatigue, feeling cold, and anorexia.