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Product name:
Profinil
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Generic name:
Modafinil
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Dosage form:
Oral tablets
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Packaging:
Box of 3 blisters of 10 scored tablets.
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Drug Category:
Neurology and Psychiatry
Indications:
Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Dosage and Administration:
Adults: The recommended starting daily dose is 200 mg. The total daily dose may be taken as a single dose in the morning or as two doses, one in the morning and one at noon, according to physician assessment of the patient and the patient's response. Doses of up to 400 mg in one or two divided doses can be used in patients with insufficient response to the initial 200 mg modafinil dose.
Long-term use: Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks).
Renal impairment: There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment.
Hepatic impairment: The dose of modafinil should be reduced by half in patients with severe hepatic impairment.
Contraindication:
Hypersensitivity to the active substance or to any of the excipients. Uncontrolled moderate to severe hypertension.
Cardiac arrhythmias.
