Stavudine For Solution
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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
There is currently no drug history available for this drug.
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:
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: methyparaben, propylparaben, mannitol, carboxymethyl cellulose sodium, sodium saccharin and strawberry cream flavour.
Sources
Stavudine For Solution Manufacturers
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Cipla Limited
![Stavudine For Solution [Cipla Limited]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Stavudine For Solution | Cipla Limited
The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.
2.1 Recommended Adults DosageThe 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 AdjustmentRenal 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 * Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days. Creatinine Clearance
(mL/min)
Recommended Stavudine Dose
by Patient Weight
At least 60 kg
Less than 60 kg
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 SolutionPrior 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:
Add 200 mL of purified water to the container. 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. 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.
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