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Armodafinil oral tablets
NUVIGIL™ |
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FDA Approval: |
June 2007 |
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Indication: |
Improve wakefulness in obstructive sleep apnea/hypopnea syndrome, narcolepsy,
and shift work sleep disorder |
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Pharmacology: |
CNS stimulant, R-enantiomer of modafinil |
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Usual Dose: |
150 mg to 250 mg once a day |
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Contraindications: |
Hypersensitivity to armodafinil, modafinil, or any ingredient |
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Warnings: |
Modafinil has been associated with serious rashes, Stevens-Johnson syndrome,
multi-organ hypersensitivity, and a fatality Armodanifinil has been associated
with angioedema and anaphylactoid reactions
Not approved for use in pediatric patients - serious rashes have occurred
with modafinil
Frequently reassess patients for degree of sleepiness; CPAP compliance; level
of wakefulness may not normalize in patients with abnormal sleepiness
Psychiatric side effects including mania, delusions, hallucinations, and
suicidal ideation; consider discontinuation if side effects occur
Armodafinil should only be used after the sleep disorder has been diagnosed
and evaluated
Patients should avoid driving or operating machinery until they know how the
drug affects their capabilities
Use caution in patients with recent history of myocardial infarction or
unstable angina
Efficary of hormonal contraceptives may be decreased; patients should use
alternate contraceptive methods
Cyclosporine blood levels may be decreased; concentrations should be
monitored
Reduce dose in severe hepatic impairment
Safety and efficacy has not been established in patients younger than 17
years or over 65 years
Caution is recommended in breastfeeding women |
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Pregnancy Category: |
C |
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Side Effects: |
Common: Headache
Nausea
Dizziness
Insomnia |
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Drug Interactions: |
Potent CYP450 3A4/5 inducers or inhibitors CYP450 3A4/5 or 2C19 substrates
carbamazepine
phenobarbital
rifampin
ketoconazole
erythromycin
cyclosporine
ethinyl estradiol
midazolam
triazolam
phenytoin
diazepam
propranolol
omeprazole
clomipramine
MAOI inhibitors
warfarin
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