COOPER PHARMA MODCOP(MODAFINIL)

COOPER PHARMA MODCOP(MODAFINIL 100MG/TAB=50TABLET)

(MODAFINAL) (modafinil)

What is Modafinil

Modafinil is a prescription medicine used to treat the symptoms of excessive sleepiness caused by obstructive sleep apnea, narcolepsy and shift work sleep disorder. Provigil may be used alone or with other medications.

Modafinil belongs to a class of drugs called Stimulants, CYP3AF Inducers, Moderate.

Modafinil is NOT safe and effective in children.

What are the possible side effects of Modafinil?

Modafinil may cause serious side effects including:

• skin rash (no matter how small),
• hives,
• blisters or peeling skin,
• mouth sores,
• trouble swallowing,
• fever,
• shortness of breath,
• swelling in your legs,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• swelling in your face, eyes, lips, tongue or throat,
• depression,
• anxiety,
• suicidal thoughts or actions,
• hallucinations,
• unusual thoughts or behavior,
• aggression,
• being more active or talkative than usual,
• chest pain,
• trouble breathing, and
• uneven heartbeats

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Modafinil include:

• headache,
• dizziness,
• feeling nervous,
• anxiety,
• back pain,
• nausea,
• diarrhea,
• upset stomach,
• sleep problems (insomnia), and
• stuffy nose

Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Provigil. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

DESCRIPTION

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.

The chemical structure is:

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.

Modafinil tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

INDICATIONS

Modafinil 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, Modafinil 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 Modafinil for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

Doses up to 200 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 Modafinil for patients with SWD is 100-200 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 Modafinil 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, scored, tablet, debossed with “Modafinil” on one side and “100 MG” on the other.

Storage And Handling

Modafinil tablets are available as follows:

100 with “Modafinil” on one side and “100 MG” on the other. NDC 63459-201-30 – Bottles of 50

Storage

Store at 20°-25°C (68°-77°F).

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

• Serious Rash, including Stevens-Johnson Syndrome [see WARNINGS AND PRECAUTIONS]
• Angioedema and Anaphylaxis Reactions [see WARNINGS AND PRECAUTIONS]
• Multi-organ Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Persistent Sleepiness [see WARNINGS AND PRECAUTIONS]
• Psychiatric Symptoms [see WARNINGS AND PRECAUTIONS]
• Effects on Ability to Drive and Use Machinery [see WARNINGS AND PRECAUTIONS]
• Cardiovascular Events [see WARNINGS AND PRECAUTIONS]