DOSAGE AND ADMINISTRATION
The interval between doses of ZERIT (stavudine) should be 12 hours. ZERIT may be taken with or without food.
Adults: The recommended dose based on body weight is as follows:
- 40 mg twice daily for patients ≥60 kg.
- 30 mg twice daily for patients <60 kg.
Pediatrics: The recommended dose for newborns from birth to 13 days old is 0.5 mg/kg/dose given every 12 hours (see CLINICAL PHARMACOLOGY). 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.
Patients should be monitored for the development of peripheral neuropathy, which is usually manifested by numbness, tingling, or pain in the feet or hands. These symptoms may be difficult to detect in young children (see WARNINGS). 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 Symptoms may resolve if therapy is withdrawn promptly.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:
- 20 mg twice daily for patients ≥60 kg.
- 15 mg twice daily for patients <60 kg.
If peripheral neuropathy recurs after resumption of ZERIT, permanent discontinuation should be considered.
ZERIT may be administered to adult patients with impaired renal function with adjustment in dose as shown in Table 12.
Table 12: Recommended Dosage Adjustment for Renal Impairment
|Recommended ZERIT 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 ZERIT in this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered.
The recommended dose is 20 mg every 24 hours (≥60 kg) or 15 mg every 24 hours (<60 kg), administered after the completion of hemodialysis and at the same time of day on non-dialysis days.
Method of Preparation
ZERIT (stavudine) for Oral Solution
Prior to dispensing, the pharmacist must constitute the dry powder with purified water to a concentration of 1 mg stavudine per mL of solution, as follows:
- 1) Add 202 mL of purified water to the container.
- 2) Shake container vigorously until the powder dissolves completely. Constitution in this way produces 200 mL (deliverable volume) of 1 mg/mL stavudine solution. The solution may appear slightly hazy.
- 3) Dispense solution in original container with measuring cup provided. Instruct patient to shake the container vigorously prior to measuring each dose and to store the tightly closed container in a refrigerator, 2° to 8° C (36° to 46° F). Discard any unused portion after 30 days.