CONTRAINDICATIONS
Provigil (modalert, modafinil) is contraindicated in patients with known hypersensitivity to modafinil.
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PRECAUTIONS
# General
Although modafinil has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that Modalert (modafinil, provigil) therapy will not adversely affect their ability to engage in such activities.
# Patients with Severe Renal Impairment
In patients with severe renal impairment (mean creatinine clearance = 16.6 mL/min), a 200 mg single dose of modafinil did not lead to increased exposure to modafinil but resulted in much higher exposure to the inactive metabolite, modafinil acid, than is seen in subjects with normal renal function. There is little information available about the safety of such levels of this metabolite.
# Patients with Severe Hepatic Impairment
In patients with severe hepatic impairment, with or without cirrhosis, Modalert should be administered at a reduced dose as the clearance of modafinil was decreased compared to that in normal subjects.
# Elderly Patients
To the extent that elderly patients may have diminished renal and/or hepatic function, dosage reductions should be considered.
# Patients Using Contraceptives
The effectiveness of steroidal contraceptives may be reduced when used with Modalert tablets and for one month after discontinuation of therapy (See Potential Interactions with Drugs That Inhibit, Induce, or are Metabolized by Cytochrome P-450 Isoenzymes and Other Hepatic Enzymes). Alternative or concomitant methods of contraception are recommended for patients treated with PROVIGIL tablets, and for one month after discontinuation of PROVIGIL.
# Nursing
Patients should be advised to notify their physician if they are breast feeding an infant.
# Alcohol
Patients should be advised that it is prudent to avoid alcohol while taking Modalert tablets.
# Nursing Mothers
Should be exercised when PROVIGIL tablets are administered to a nursing woman.
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