August 30, 2015
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Provigil

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Provigil




Indications
Dosage
How Supplied

INDICATIONS

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].

HOW SUPPLIED

Dosage Forms And Strengths

  • 100 mg – capsule-shaped, white to off white, tablet, debossed with “PROVIGIL” on one side and “100 MG” on the other.
  • 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:

100 mg: Each capsule-shaped, white to off white tablet is debossed with “PROVIGIL” on one side and “100 MG” on the other. NDC 63459-101-30 – Bottles of 30

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

Storage

Store at 20°-25°C (68°-77°F).

Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised January 2015

Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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