The interval between doses of STAVIR Capsules should be 12 hours. STAVIR Capsules may be taken with or without food.
Adults
The recommended dose, based on body weight, is as follows:
40 mg every 12 hours for patients ≥60 kg
30 mg every 12 hours for patients <60 kg
Pediatric Use
The recommended dose for newborns from birth to 13 days old is 0.5 mg/kg/dose given every 12 hours. The recommended dose for pediatric patients at least 14 days old and weighing less than 30 kg is 1 mg/kg/dose, given every 12 hours. Pediatric patients weighing 30 kg or greater should receive the recommended adult dosage.
Dosage Adjustment
Peripheral Neuropathy
Patients should be monitored for the development of peripheral neuropathy, which is usually characterized by numbness, tingling, or pain in the feet or hands. These symptoms may be difficult to detect in young children (see Warnings and Precautions ). If these symptoms develop during treatment, stavudine therapy should be interrupted. Symptoms may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy. If symptoms resolve completely, patients may tolerate resumption of treatment at one-half the recommended dose, as follows:
20 mg every 12 hours for patients ≥60 kg
15 mg every 12 hours for patients <60 kg
If peripheral neuropathy recurs after resumption of stavudine, permanent discontinuation of stavudine should be considered.
Renal Impairment STAVIR Capsules may be administered to adult patients with impaired renal function after an adjustment in dose, as shown in Table 5.
Table 5: Recommended Dosage Adjustment for Renal Impairment
Creatinine Clearance (mL/min) |
Recommended STAVIR Dose by Patient Weight |
|
≥60 kg |
<60 kg |
>50 |
40 mg every 12 hours |
30 mg every 12 hours |
26–50 |
20 mg every 12 hours |
15 mg every 12 hours |
10–25 |
20 mg every 24 hours |
15 mg every 24 hours |
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, 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 this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered.
Hemodialysis Patients
The recommended dose is 20 mg every 24 hours (>60 kg) of 15 mg every 24 hours (<60 kg), administered after the completion of hemodialysis and at the same time of day on non-dialysis days.
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