Monograph Details
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Pain & Pyrexia
> Narcotic analgesics
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FENTORA |
| Manufacturer |
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Cephalon, Inc. |
| Legal Classification |
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CII |
| Pharmacological Class |
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Opioid analgesic. |
| Generic Name |
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Fentanyl (as citrate) 100 micrograms, 200 micrograms, 400 micrograms, 600 micrograms, 800 micrograms; buccal tabs. |
| Indications |
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Management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, or equivalent, for ≥1 week. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Place tablet in buccal cavity (above a rear molar, between upper cheek and gum). Do not swallow whole, split, suck, or chew. Individualize; not interchangeable on a mcg/mcg basis with other oral fentanyl products. Initially 100micrograms/dose; if pain unrelieved, may repeat in 30minutes, then must wait at least 4hrs before treating another episode. Previously on oral fentanyl: see literature. Reevaluate maintenance pain therapy if >4 doses/24hrs is needed. |
| Contraindications |
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Not for opioid intolerant patients. Not for treating acute or post-operative pain. During or within 14 days of MAOIs. |
| Precautions |
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Respiratory depression. >Grade 1 mucositis. Head injury. CNS depression. Increased intracranial pressure. Impaired cardiovascular (eg, bradyarrhythmias), pulmonary, hepatic, renal, thyroid function. Avoid abrupt cessation. Reevaluate periodically. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Potentiates CNS depression with benzodiazepines, barbiturates, alcohol, other CNS depressants, other psychoactive substances. Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, troleandomycin, ritonavir, nelfinavir, amprenavir, fosamprenavir, aprepitant, nefazodone, verapamil, diltiazem, grapefruit juice); monitor for extended period of time. Antagonized by CYP3A4 inducers. |
| Adverse Reactions |
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GI upset, constipation, local reactions, fatigue, anemia, dizziness, peripheral edema, dehydration, headache. |
| Extra Text |
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Note: For use only by clinicians trained to use CII opioids for cancer pain. Caution patients and caregivers in proper handling and disposal; may be fatal to children. |
| How Supplied |
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Tabs—28 (4 tabs x 7 cards) |
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