Modafinil 200mg (Modalert/Provigil)

$2.9

Provigil/Modafinil/Modalert is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

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DESCRIPTION

MODALERT (PROVIGIL/MODAFINIL)
Modafinil (provigil/modalert) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound.

PHARMACOKINETICS
Once daily dosing consists of 90% of the l-isomer and 10% of the d-isomer. The effective elimination half-life of modafinil after multiple doses is about 15 hours. The enantiomers of modafinil exhibit linear kinetics upon multiple dosing of 200-600 mg/day once daily in healthy volunteers.
Absorption of PROVIGIL tablets is rapid, with peak plasma concentrations occurring at 2-4 hours.
Food has no effect on overall PROVIGIL bioavailability; however, its absorption (t-max) may be delayed by approximately one hour if taken with food.
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, and talc.

INDICATIONS

Provigil (modafinil) is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

In patients with severe hepatic impairment, the dose of PROVIGIL should be reduced to one-half of that recommended for patients with normal hepatic function.
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
In elderly patients, elimination of PROVIGIL and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.

DOSAGE

The dose of PROVIGIL is 200 mg/day, given as a single dose in the morning.
Doses of 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose.

CONTRAINDICATIONS

CONTRAINDICATIONS
Provigil (modalert, modafinil) is contraindicated in patients with known hypersensitivity to modafinil.

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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