Stavudine Solution label

Stavudine Solution

Stavudine Solution Recall

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Uses

Stavudine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].

History

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Other Information

Stavudine (d4T) is a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus type 1 (HIV-1). The chemical name for stavudine is 2′,3′-didehydro-3′-deoxythymidine. Stavudine has the following structural formula:

a1ac2cfb-figure-01

Stavudine is a white to off-white crystalline solid with the molecular formula C10H12N2O4 and a molecular weight of 224.2. The solubility of stavudine at 23°C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23°C is 0.144.

Powder for Oral Solution: Stavudine is available as a dye-free, fruit-flavored powder in bottles with child-resistant closures providing 200 mL of a 1 mg/mL stavudine oral solution upon constitution with water per label instructions. The powder for oral solution contains the following inactive ingredients: carboxymethyl cellulose sodium, mannitol, methylparaben, propylparaben, sodium saccharin, and strawberry cream flavour.

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Stavudine Solution Manufacturers

Boca Pharmacal, Llc
No Recall
Stavudine Solution | Boca Pharmacal, Llc

The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.
2.1    Recommended Adults Dosage
The recommended adult dosage is based on body weight as follows:

•    For patients weighing less than 60 kg: 30 mg every 12 hours.

•    For patients weighing at least 60 kg: 40 mg every 12 hours.
2.2    Recommended Pediatric Dosage
•    For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours.

•    For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours.

•    For pediatric patients weighing at least 30 kg: use the recommended adult dosage.
2.3    Dosage Adjustment
Renal Impairment
Adult Patients: Stavudine may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.
Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment Creatinine Clearance
(mL/min) Recommended Stavudine Dose by Patient Weight At least 60 kg Less than 60 kg * Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days. greater than 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 Hemodialysis 20 mg every 24 hours* 15 mg every 24 hours*
Pediatric Patients: 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. There are insufficient data to recommend a specific dose adjustment of stavudine in this patient population.
2.4    Method of Preparation 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 200 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.