Special Alerts:
[Posted 10/24/2007] FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for modafinil (Provigil). Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.
Physicians should instruct their patients to immediately discontinue the use of modafinil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that modafinil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with modafinil. Caution should be exercised when modafinil is given to patients with a history of psychosis, depression, or mania.
Additional labeling revisions were made to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE INSERT sections. See revised labeling below. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil, http://www.fda.gov/medwatch/safety/2007/Provigil_dhcpletter091207_final.pdf and http://www.fda.gov/medwatch/safety/2007/Provigil_PI.pdf.
Before using modafinil, tell your doctor if you have angina (chest pain), liver or kidney disease, a heart problem, a history of drug addiction, if you take blood pressure medication, or if you have recently had a heart attack.
Modafinil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.Stop taking modafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to modafinil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.
There may be other drugs that can interact with modafinil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Modafinil is a medication that promotes wakefulness.
Modafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
Modafinil may also be used for purposes other than those listed in this medication guide.
Before using modafinil, tell your doctor if you are allergic to any drugs, or if you have:
angina (chest pain);
cirrhosis or other liver problem;
kidney disease;
a heart muscle or valve disorder such as mitral valve prolapse;
a history of drug addiction;
if you take blood pressure medications; or
if you have recently had a heart attack.
If you have any of these conditions, you may not be able to use modafinil, or you may need dosage adjustments or special tests during treatment.
Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to modafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.
Stop taking modafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Modafinil can make certain types of birth control pills less effective, which could result in an unplanned pregnancy. Talk with your doctor about the best methods of birth control to use while taking modafinil. It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give modafinil to anyone younger than 16 years old.![]() |
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