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PROVIGIL (MODAFINIL): PRESCRIBING INFORMATION

DESCRIPTION

Provigil (Modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

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: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, povidone, croscarmellose sodium, and magnesium stearate.


INDICATIONS AND USAGE

Provigil (Modafinil) is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.

In OSA, Modafinil (Provigil) is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Provigil (Modafinil). If this medication is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe Provigil (Modafinil) tablets for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.


CONTRAINDICATIONS

Modafinil (Provigil) is contraindicated in patients with known hypersensitivity to modafinil, armodafinil or its inactive ingredients.


DOSAGE AND ADMINISTRATION

Provigil dosage and administration


CLINICAL PHARMACOLOGY

Provigil clinical pharmacology


PHARMACOKINETICS

Provigil pharmacokinetics


CLINICAL TRIALS

The effectiveness of Provigil (Modafinil) tablets in reducing excessive sleepiness has been established in the following sleep disorders: narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD).

Provigil clinical trials for narcolepsy

Provigil clinical trials for obstructive sleep apnea (OSA)

Provigil clinical trials for shift work disorder (SWD)


WARNINGS

Provigil warnings


PRECAUTIONS

Provigil precautions


USE IN SPECIAL POPULATIONS

Provigil use in special populations


SPECIAL PRECAUTIONS

Provigil special precautions


DRUG INTERACTIONS

Provigil drug interactions


ADVERSE REACTIONS

Provigil adverse reactions


DRUG ABUSE AND DEPENDENCE

Provigil drug abuse and dependence


OVERDOSAGE

Provigil overdosage


HOW SUPPLIED

Provigilr (Modafinil) tablets

100 mg each capsule-shaped, white, uncoated tablet is debossed with "PROVIGIL" on one side and "100 MG" on the other. Bottles of 100

200 mg each capsule-shaped, white, scored, uncoated tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other. Bottles of 100

Store at 20° - 25° C (68° - 77° F).

Manufactured and distributed by Cephalon pharmaceutical company and its divisions.

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