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Generic Zerit Stavudine 40mg

Deaths attributed to hepatotoxicity have occurred in patients receiving this combination. Numbness, pain, and tingling of the hands and feet can be signs of an overdose. Most of these cases occurred in the setting of lactic acidosis. The evolution of motor weakness may mimic the clinical presentation of Guillain-Barre syndrome (including respiratory failure). Symptoms may continue or worsen following discontinuation of therapy. Peripheral neuropathy, manifested by numbness, tingling, or pain in the hands or feet, has been reported in patients receiving Zerit therapy. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy.

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Warnings

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Zerit. Zidovudine competitively inhibits the intracellular phosphorylation of stavudine. Stavudine was not mutagenic in the Ames, E. coli reverse mutation, or the CHO/HGPRT mammalian cell forward gene mutation assays, with and without metabolic activation. Health care providers caring for HIV-infected pregnant women receiving stavudine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome.

Zerit Precautions

Benign and malignant liver tumors in mice and rats and malignant urinary bladder tumors in male rats occurred at levels of exposure 250 (mice) and 732 (rats) times human exposure at the recommended clinical dose. Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to stavudine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Fatal lactic acidosis has occurred in patients treated with Zerit in combination with other antiretroviral agents. Patients with suspected lactic acidosis should immediately suspend therapy with Zerit.

Drug Interactions (See Also Clinical Pharmacology)

Therefore, use of zidovudine in combination with Zerit should be avoided. In 2-year carcinogenicity studies in mice and rats, stavudine was noncarcinogenic at doses which produced exposures (AUC) 39 and 168 times, respectively, human exposure at the recommended clinical dose. Stavudine produced positive results in the in vitro human lymphocyte clastogenesis and mouse fibroblast assays, and in the in vivo mouse micronucleus test. In the in vitro assays, stavudine elevated the frequency of chromosome aberrations in human lymphocytes (concentrations of 25 to 250 mg/mL, without metabolic activation) and increased the frequency of transformed foci in mouse fibroblast cells (concentrations of 25 to 2500 mg/mL, with and without metabolic activation).

Stavudine Adverse Reactions

A study in rats showed that stavudine is transferred to the fetus through the placenta. The concentration in fetal tissue was approximately one half the concentration in maternal plasma. Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies of stavudine in pregnant women. Stavudine should be used during pregnancy only if the potential benefit justifies the potential risk.