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Zerit (Stavudine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ZERIT (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).

CLINICAL STUDIES

Combination Therapy

The combination use of ZERIT is based on the results of clinical studies in HIV-infected patients in double- and triple-combination regimens with other antiretroviral agents.

One of these studies (START 1) was a multicenter, randomized, open-label study comparing ZERIT (40 mg twice daily) plus lamivudine plus indinavir to zidovudine plus lamivudine plus indinavir in 202 treatment-naive patients. Both regimens resulted in a similar magnitude of inhibition of HIV RNA levels and increases in CD4 cell counts through 48 weeks.

Monotherapy

The efficacy of ZERIT was demonstrated in a randomized, double-blind study (AI455-019, conducted 1992-1994) comparing ZERIT with zidovudine in 822 patients with a spectrum of HIV-related symptoms. The outcome in terms of progression of HIV disease and death was similar for both drugs.

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.

Dosage Adjustment

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 Symptoms may resolve if therapy is withdrawn promptly.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.


Renal Impairment

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
Creatinine
Clearance
(mL/min)
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.

Hemodialysis Patients

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° C to 8° C (36° F to 46° F). Discard any unused portion after 30 days.

HOW SUPPLIED

ZERIT® (stavudine) Capsules are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0656-1 20 mg 30 Capsules in a Blister Pack light brown 0003-1965
53808-0657-1 30 mg 30 Capsules in a Blister Pack light orange & dark orange 0003-1966
53808-0795-1 40 mg 30 Capsules in a Blister Pack dark orange 0003-1967

Storage

ZERIT Capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature).

ZERIT for Oral Solution should be protected from excessive moisture and stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature). After constitution, store tightly closed containers of ZERIT for Oral Solution in a refrigerator, 2° C to 8° C (36° F to 46° F). Discard any unused portion after 30 days.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

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