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NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the Rand S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.
The chemical structure is:
Armodafinil exists in multiple crystalline forms. Form I, which is used in NUVIGIL, is the least soluble form of armodafinil and is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone and soluble in methanol. At least 90% of the armodafinil particles used in NUVIGIL have a diameter of less than 200 microns.
NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.
What are the possible side effects of armodafinil (Nuvigil)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using armodafinil and call your doctor at once if you have a serious side effect such as:
- fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
- the first sign of any type of skin rash, no matter how mild;
- bruising, severe tingling, numbness, pain, muscle weakness;
- easy bruising or bleeding;
- mouth sores, trouble...
What are the precautions when taking armodafinil (Nuvigil)?
Before taking armodafinil, tell your doctor or pharmacist if you are allergic to it; or to modafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., enlarged heart, mitral valve problem), history of problems (e.g., chest pain, irregular heartbeat) after taking stimulants such as amphetamines.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart problems (e.g., chest pain, heart attack, irregular...
Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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