Stavudine

A to Z Drug Facts

 Action Inhibits replication of HIV.

 Indications For the treatment of HIV-1 infection in combination with other antiretroviral agents.

 Contraindications Standard considerations.

 Route/Dosage

Adults: PO 40 mg q 12 hr for patients weighing at least 60 kg; 30 mg q 12 hr for patients weighing under 60 kg. May be taken without regard to food.

Children: PO 1 mg/kg/dose q 12 hr for patients weighing under 30 kg; give those weighing at least 30 kg the adult dosage.

Renal function impairment: Use drug cautiously in patients with renal impairment. Dosage adjustment based on renal function may be required (see table).

 Interactions

Didanosine: Pancreatitis has occured when in combination with stavudine (with or without hydroxyurea).

Zidovudine: May competitively inhibit the phosphorylation of stavudine; this combination is not recommended.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Peripheral neuropathy; headache; insomnia. DERMATOLOGIC: Rash. GI: Pancreatitis (may be fatal); diarrhea; nausea and vomiting; abdominal pain; anorexia. HEMATOLOGIC: Anemia; leukopenia; thrombocytopenia. HEPATIC: Lactic acidosis; hepatomegaly with hepatic steatosis. METABOLIC: AST greater than 5 times the ULN; ALT greater than 5 times ULN; amylase at least 1.4 times the ULN. OTHER: Allergic reaction; chills/fever; myalgia.

 Precautions

Pregnancy: Category C. Lactation: Undetermined; do not breast feed. Hemodialysis: 20 mg q 24 hr (patients at least 60 kg) or 15 mg q 24 hr (patients less than 60 kg) administered after the completion of hemodialysis and at the same time of the day on nondialysis days. Fat redistribution Accumulation/redistribution of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have occurred in patients receiving antiretroviral therapy. A causal relationship not established. Lactic acidosis/Severe hepatomegaly with steatosis: Fatal and nonfatal cases have been reported with the use of nucleoside analogs alone or in combination, including stavudine and other antiretrovirals; exercise caution in patients with known liver disease. Peripheral neuropathy: Symptoms may worsen temporarily following therapy discontinuation. If symptoms of peripheral neuropathy develop, then interrupt therapy. Symptoms may resolve if therapy is withdrawn promptly. If symptoms resolve completely, then resume therapy at 50% of the recommended dose. If neuropathy recurs after resumption of stavudine, consider permanent discontinuation. Manage clinically significant elevations of hepatic transaminases in the same way. Pancreatitis: Fatal and nonfatal cases have been reported when stavudine was in combination with didanosine (with or without hydroxyurea).

 Administration/Storage

• Administer bid q 12 hr without regard to meals.
• Shake solution vigorously before measuring each dose. Use measuring cup provided.
• Administer reduced dose to patient with renal impairment.
• Store tablets at controlled room temperature (59° to 86°F) in a tightly closed container protected from moisture. Store solution in refrigerator. Keep bottle tightly closed. Discard any unused solution after 30 days.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note renal or liver impairment, history of pancreatitis, and prior response to stavudine.
• Ensure that liver and renal function tests are obtained before beginning therapy and repeated periodically during therapy.
• Monitor patient for development of pancreatitis. If patient develops abdominal pain, nausea, or vomiting, or has elevated amylase or LFT results, withhold medication and contact health care provider.
• Monitor patient for signs of lactic acidosis. If patient develops profound weakness or tiredness, unexpected stomach discomfort, coldness, dizziness, or lightheadedness, or slow or irregular heartbeat, withhold drug and contact health care provider.
• Assess for evidence of peripheral neuropathy (eg, numbness, tingling, burning or pain in hands or feet) or evidence of opportunistic infections. Notify health care provider if these occur.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Warn patient that this drug is not to be used by itself but is combined with other antiviral agents.
• Advise patient to take drug bid q 12 hr without regard to meals.
• Remind patient using solution to use measuring cup provided with drug and to shake bottle vigorously before measuring each dose.
• Instruct patient to report the following symptoms immediately to the health care provider: abdominal pain, nausea, or vomiting; numbness, tingling, burning, or pain in hands or feet; profound weakness or tiredness, unexpected stomach discomfort, feeling cold, dizzy, or lightheaded, slow or irregular heartbeat.
• Inform patient that drug does not completely eliminate HIV virus and therefore does not reduce risk of transmitting HIV. Appropriate precautions still must be followed.
• Advise patient that drug is not a cure for HIV infection and that the patient may continue to acquire illnesses associated with HIV infection, including opportunistic infections and to remain under a health care provider's care.
• Instruct patient to not take any prescription or OTC medications or dietary supplements unless advised by health care provider.
• Instruct patient to notify health care provider if pregnant, planning on becoming pregnant, or are breastfeeding.
• Advise patient that follow-up visits and lab tests may be required to monitor therapy and to keep appointments.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts