Composition:

STAVUDINE ORAL SUSPENSION
Each ml of reconstituted solution contains:Stavudine Suspension - 1 mg

Indications:

In the treatment of Human immunodeficiency virus (HIV) infection.


Contraindications:

Hypersensitivity to stavudine or any of the components contained in the formulation.


Warnings and Precautions:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. Fatal and nonfatal pancreatitis has been reported during therapy in combination with didanosine.


Drug Interactions:

Zidovudine may competitively inhibit the intracellular phosphorylation of stavudine. Therefore, Stavudine should not be used in combination with zidovudine. Hydroxyurea may enhance the antiretroviral activity of didanosine or stavudine. The addition of hydroxyurea to combination HIV treatment regimens containing didanosine and stavudine has been associated with an increased risk of pancreatitis and hepatotoxocity.


Adverse Reactions:

Peripheral neuropathy, headache, anorexia, diarrhea, nausea/vomiting, arthralgia, hypersensitivity, myalgia, pancreatitis.


Dosage And Administration:

  • Newborns from birth to 13 days old: The recommended dose for newborns is 0.5 mg/kg/dose given every 12 hours.
  • Children > 14 days old and weighing <30 kg: The recommended dose is 1 mg/kg/dose, given every 12 hours.
  • Children weighing 30 to 60 kg: 30 mg orally every 12 hours.
  • Dosage adjustments for patients who resume stavudine therapy following resolution of symptoms of peripheral neuropathy: Reduce recommended dose by 50%.

  • Patients with Renal Impairment:

    The clearance of stavudine may be altered in children with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of stavudine in children, a reduction in the dose and/or an increase in the interval between doses should be considered.


    Intermittent hemodialysis:

    The recommended dose is 15 mg orally every 24 hours in patients weighing < 60 kg, administered after the completion of hemodialysis and at the same time of day on non-dialysis days.