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Pharmacologic class: Nucleoside reverse transcriptase inhibitor
Therapeutic class: Antiretroviral
Pregnancy risk category C
FDA Box Warning
• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have occurred with use of drug alone or in combination with other nucleoside analogs. Fatal lactic acidosis has been reported in pregnant women who received stavudine-didanosine combination with other antiretrovirals. Use this combination cautiously in pregnant women and only if potential benefit clearly outweighs potential risk.
• Pancreatitis (fatal and nonfatal cases) has occurred when stavudine was used as part of combination regimen that included didanosine, in both treatment-naive and treatment-experienced patients.
Inhibits replication of human immunodeficiency virus (HIV) by interfering with the enzyme reverse transcriptase, thereby terminating DNA chain
Capsules: 15 mg, 20 mg, 30 mg, 40 mg
Powder for oral solution: 1 mg/ml
Indications and dosages
➣ HIV-1 infection
Adults weighing 60 kg (132 lb) or more: 40 mg P.O. q 12 hours
Adults and children weighing less than 60 kg (132 lb): 30 mg P.O. q 12 hours
Children weighing 30 kg (66 lb) or more: 30 mg P.O. q 12 hours
Children 14 days and older who weigh less than 30 kg (66 lb): 1 mg/kg P.O. q 12 hours
Newborns to infants 13 days old: 0.5 mg/kg P.O. q 12 hours
• Renal impairment
• Elderly patients
• Hypersensitivity to drug or its components
Use cautiously in:
• advanced HIV infection, bone marrow depression, renal failure, peripheral neuropathy, hepatic dysfunction, hyperlactatemia, lactic acidosis
• concurrent use of hydroxyurea or didanosine (avoid use)
• elderly patients (with renal impairment)
• pregnant or breastfeeding patients.
• Give with or without food.
• Know that drug is usually given with other antiretrovirals.
CNS: headache, insomnia, peripheral neuropathy
GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, pancreatitis
Hematologic: anemia, leukopenia, thrombocytopenia
Hepatic: hepatic steatosis, hepatitis, hepatic failure
Metabolic: increased glucose tolerance, lactic acidosis
Other: body fat redistribution or accumulation, chills, fever, allergic reaction, immune reconstitution syndrome
Drug-drug. Chloramphenicol, dapsone, didanosine, ethambutol, hydralazine, hydroxyurea, lithium, phenytoin, vincristine, zalcitabine: increased risk of peripheral neuropathy
Doxorubicin, ribavarin, zidovudine: inhibition of stavudine's absorption and metabolism
Myelosuppressants: increased bone marrow depression
Drug-diagnostic tests. Alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, gamma-glutamyl transferase, lipase: increased levels
Neutrophils, platelets: decreased counts
☞ Monitor closely for signs and symptoms of lactic acidosis, hyperlactatemia, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Consult prescriber about suspending drug if these occur. Consider permanent discontinuation of drug for patients with confirmed lactic acidosis.
• Monitor patient for signs and symptoms of immune reconstitution syndrome.
• Watch for and report onset and worsening of peripheral neuropathy.
☞ Monitor CBC. Report evidence of bone marrow depression.
• Monitor liver function tests and blood chemistry results.
• Tell patient he may take with or without food.
☞ Teach patient to recognize and promptly report signs and symptoms of lactic acidosis (such as fatigue, GI distress, and difficult or rapid breathing), hepatotoxicity, immune reconstitution syndrome, and pancreatitis.
• Instruct patient to report numbness or tingling in arms, legs, hands, or feet.
• Caution female patient not to breastfeed, because she may transmit drug effects and HIV to infant.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.