Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Stavudine

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Stavudine (d4T, Zerit)
Stavudine (d4T, Zerit)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Powder for Oral Solution: 1 mg/mL
Capsules: 15 mg, 20 mg, 30 mg, and 40 mg

Generic Formulations
Powder for Oral Solution: 1 mg/mL
Capsules: 15 mg, 20 mg, 30 mg, and 40 mg
Dosing Recommendations Selected Adverse Events
Note: Stavudine is no longer recommended for use in children by the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, because it causes higher rates of adverse effects than other nucleoside reverse transcriptase inhibitors (NRTIs).

Pediatric (Aged ≥14 Days and Weighing <30 kg) Dose:
  • 1 mg/kg per dose twice daily
Adolescent (Weighing ≥30 kg) and Adult Dose:
  • 30 mg per dose twice daily
  • Associated with a higher risk of mitochondrial toxicity than other NRTI drugs
  • Peripheral neuropathy is dose-related and occurs more frequently in patients who have advanced HIV disease or a prior history of peripheral neuropathy, and in patients receiving other drugs associated with neuropathy.
  • Facial/peripheral lipoatrophy
  • Pancreatitis
  • Lactic acidosis/severe hepatomegaly with hepatic steatosis (higher incidence than with other NRTIs). The risk increases when stavudine is used in combination with didanosine.
  • Dyslipidemia
  • Insulin resistance, asymptomatic hyperglycemia
  • Rapidly progressive ascending neuromuscular weakness (rare)
Special Instructions
  • Stavudine can be given without regard to food.
  • Shake stavudine oral solution well before use. Keep refrigerated; the solution is stable for 30 days.
Metabolism/Elimination
  • Renal excretion 50%. Decrease dose in patients with renal dysfunction.
  • Stavudine is phosphorylated intracellularly to the active metabolite stavudine triphosphate

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