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Modafinil

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(CAS: 68693-11-8)

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MODAFINIL

Manufacturer: Cephalon

Storage of the drug: 20<-25< C (68<-77< F).

Manufactured for: Cephalon, Inc. West Chester, PA 19380

U.S. Patent Nos. RE37,516 / 6,462,089

 

DESCRIPTION

PROVIGIL ( modafinil ) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound.

Chemical name: 2-[(diphenylmethyl)sulfinyl]acetamide.

Molecular formula: C15H15NO2S

Molecular weight is 273.36

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

OVERDOSAGE

Human Experience

In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of 200 mg) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days. In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects. Adverse experiences that were reported at these doses included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea and decreased prothrombin time.

From post-marketing experience, there have been no reports of fatal overdoses involving modafinil alone (doses up to 12 grams). Overdoses involving multiple drugs, including modafinil, have resulted in fatal outcomes. Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.

Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age. The highest reported accidental ingestion on a mg/kg basis occurred in a three-year-old boy who ingested 800-1000 mg (50-63 mg/kg) of modafinil. The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults.

What is the most important information I should know about modafinil?

#Use caution when driving, operating machinery, or performing other hazardous activities. Modafinil may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities.
#It is best to avoid alcohol while taking modafinil. Alcohol or modafinil may have altered effects if taken together.
#Modafinil may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking modafinil, and for one month after stopping modafinil, if prevention of pregnancy is desired.
#Modafinil may be habit forming. You should discuss the abuse and dependence potential of modafinil with your doctor. Do not stop taking modafinil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.

What is modafinil?

# The exact way that modafinil works is not known.
# Modafinil is used to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/ hypoapnea syndrome (OSAHS), and shift work sleep disorder (SWSD).
# Modafinil may also be used for purposes other than those listed in this medication guide.

How should I take modafinil?

# Take modafinil exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
# Take each dose with a full glass of water.
# Modafinil can be taken with or without food.
# Modafinil is usually taken once a day. Follow your doctor's instructions.
# It is important to take modafinil regularly to get the most benefit.
# Modafinil is not a replacement for sleep. Modafinil may reduce the signs of sleepiness, but may not completely treat this problem. Some drowsiness may continue. Potentially hazardous activities such as driving or operating machinery should only be performed if the level of wakefulness achieved is sufficient to permit such activities.
# Other treatments such as CPAP (continuous positive airway pressure) use should be continued as directed by your doctor if you have obstructive sleep apnea/ hypoapnea syndrome (OSAHS) and are taking modafinil.
# Modafinil may be habit forming. You should discuss the abuse and dependence potential of modafinil with your doctor. Do not stop taking modafinil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.
# Store modafinil at room temperature away from moisture and heat.

What happens if I miss a dose?

# Take the missed dose as soon as you remember as directed by your doctor. A missed dose taken late in the waking day may cause insomnia. If you don't remember until it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What should I avoid while taking modafinil?

# Use caution when driving, operating machinery, or performing other hazardous activities. Modafinil may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities.
# It is best to avoid alcohol while taking modafinil. Alcohol or modafinil may have altered effects if taken together.
# Modafinil may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking modafinil, and for one month after stopping modafinil, if prevention of pregnancy is desired.

What are the possible side effects of modafinil?

# If you experience any of the following uncommon but serious side effects, stop taking modafinil and seek emergency medical attention or contact your doctor immediately:
# an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
# irregular heartbeats;
# low or high blood pressure; or
# shortness of breath.
# Other, less serious side effects may be more likely to occur. Continue to take modafinil and talk to your doctor if you experience
# headache;
# infection;
# nausea, decreased appetite, or diarrhea;
# chills;
# dry mouth;
# runny nose;
# sore throat;
# nervousness;
# anxiety;
# dizziness;
# insomnia;
# depression; or
# numbness or tingling.
# Modafinil may be habit forming. You should discuss the abuse and dependence potential of modafinil with your doctor. Do not stop taking modafinil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.
# Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.