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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 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment 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 and during treatment with PROVIGIL for excessive sleepiness.
DOSAGE AND ADMINISTRATION
Dosage In Narcolepsy And Obstructive Sleep Apnea (OSA)
The recommended dosage of PROVIGIL for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Doses up to 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/day dose [see CLINICAL PHARMACOLOGY and Clinical Studies].
Dosage In Shift Work Disorder (SWD)
The recommended dosage of PROVIGIL for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
Dosage Modifications In Patients With Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of PROVIGIL should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
Use In Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations].
Dosage Forms And Strengths
200 mg – capsule-shaped, white to off white, scored, tablet, debossed with “PROVIGIL” on one side and “200 MG” on the other
Storage And Handling:
PROVIGIL® (modafinil) tablets are available as follows:
200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with “PROVIGIL” on one side and “200 MG” on the other. NDC 63459-201-30 – Bottles of 30
Store at 20°-25°C (68°-77°F)