Detailed Drug Information:

DRUG CLASS AND MECHANISM: Stavudine is an oral medication that is used for the treatment of infections with the human immunodeficiency virus (HIV). It is in a class of drugs called reverse transcriptase inhibitors which also includes zalcitabine (Hivid), zidovudine (Retrovir), didanosine (Videx), and lamivudine (Epivir). During infection with HIV, the HIV virus multiplies within the body's cells. The newly-formed viruses then are released from the cells and spread throughout the body where they infect other cells. In this manner, the infection continually spreads to new, uninfected cells that the body is continuallyproducing, and HIV infection is perpetuated. When producing new viruses, the HIV virus must manufacture new DNA for each virus. Reverse transcriptase is the enzyme that the virus uses to form this new DNA. Specifically, stavudine is converted within the body to its active form (stavudinetriphosphate). This active form is similar to thymidine triphosphate, a chemical that is required by the HIVvirus to make new DNA. The reverse transcriptase uses stavudine triphosphate instead of thymidine triphosphate for making DNA, and it is the stavudine triphosphate that interferes with the reverse transcriptase. Stavudine does not killexisting HIV virus and it is not a cure for HIV. Stavudine was approved by the FDA in June, 1994.

PREPARATIONS: Capsules: 15, 20, 30 and 40mg. Powder for oral solution, 1 mg/ml.

STORAGE: Store capsules at room temperature, 15-30°C (59-86°F). The dry powder for oral solution should be kept at room temperature and away form moisture. Solutions should be refrigerated.

PRESCRIBED FOR: Stavudine is used for the treatment of HIV infection.

DOSING: The recommended dose for adults is 40 mg twice daily for those weighing 60 kg or more and 30 mg twice daily if less than 60 kg.

Children weighing less than 30 kg should receive 1 mg/kg. Children weighing 30 kg or more should be treated like adults.

Stavudine may be administered without regard to meals.

DRUG INTERACTIONS: Zidovudine prevents the conversion of stavudine to its active form (stavudine triphosphate) and this reduces the action of stavudine against the HIV virus. Therefore stavudine should not be combined with zidovudine.

PREGNANCY: Use of stavudine during pregnancy has not been adequately evaluated.

NURSING MOTHERS: It is not known whether stavudine is excreted in breast milk. HIV infected mothers should not breast feed because of the potential risk of transmitting HIV to an infant that is not infected.

SIDE EFFECTS: The most severe side effects are a decrease in blood cells, muscle pain (myopathy), pancreatitis, liver failure and metabolic disturbance (lactic acidosis). Stavudine damages nerves and can cause a severe peripheral neuropathy, a condition in which sensation in the legs and/or arms is altered or lost. Symptoms of peripheral neuropathy are tingling, numbness and pain in the feet or hands. Other side effects include chills, rash, abdominal pain, weight loss and insomnia.