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GENERIC NAME: thalidomide

BRAND NAME: Thalomid

DRUG CLASS AND MECHANISM: Thalidomide is an oral medication used for treating the skin conditions of leprosy, a disease caused by a parasite, Mycobacterium leprae. The mechanism of action of thalidomide is not well understood. The immune system reaction to Mycobacterium leprae plays an important role in producing the skin manifestations of leprosy. Scientists believe that thalidomide modifies the reaction of the immune system to Mycobacterium leprae and thereby suppresses the skin reaction. Thalidomide also is being evaluated as a treatment for HIV. Thalidomide was approved by the FDA in July, 1998.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Capsules: 50 mg

STORAGE: Store at room temperature 15-30°C (59-86°F) and protect from light.

PRESCRIBED FOR: Thalidomide is used for the treatment and prevention of skin conditions resulting from leprosy and is being evaluated for the management of HIV-related disease. Thalidomide has also been used for treating some autoimmune diseases of the connective tissues including Behcet's disease and skin manifestations of dermatomyositis.

DOSING: The recommended adult dose is 100-400 mg daily. Thalidomide should be administered in the evening at least one hour after meals and with a full glass of water.

DRUG INTERACTIONS: Thalidomide increases the sedative effect of alcohol and other drugs that cause drowsiness (e.g., VALIUM)

PREGNANCY: Thalidomide is very harmful to the fetus. Therefore, thalidomide should be avoided during pregnancy. Men and women who are taking thalidomide should use appropriate methods of birth control. Moreover, women of childbearing age should practice two forms of birth control concurrently. Men taking thalidomide should not donate sperm, and thalidomide users should not donate blood since the recipients of the sperm and blood may receive small amounts of thalidomide.

NURSING MOTHERS: It is not known whether thalidomide is excreted in breast milk.

SIDE EFFECTS: The most common side effects are drowsiness, dizziness, low blood pressure, weakness, rash and increased sensitivity to sunlight. Thalidomide also causes nerve damage and a decrease in white blood cells. Symptoms of nerve damage are tingling, numbness and pain in the feet or hands.

Reference: FDA Prescribing Information


Last Editorial Review: 3/12/2001 8:53:00 PM




Report Problems to the Food and Drug Administration

 

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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