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Nucleoside Reverse Transcriptase Inhibitors:
Stavudine
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back to topIntroduction

The information represented on this drug does not necessarily correspond with the information that can be found in the Belgian scientific leaflet.
Stavudine was approved by the FDA in 1993 for the treatment of HIV-infected adults who have received prolonged zidovudine therapy. (124) Stavudine is a nucleoside analogue of thymidine and structurally similar to zidovudine but seems to be much better tolerated. For patients receiving zidovudine for >6 months, switching to stavudine increases CD4+ cell counts and slows clinical progression, as compared with the expected course when continuing zidovudine therapy. (100,106)

Abbreviation(s): 
Generic name:
Brand name:
d4T
stavudine
Zerit®
USA (FDA)
Adult approval date:
Pediatric approval date:
June 24, 1994
September 6, 1996
 
Bristol-Myers Squib Company
Pharmaceutical co.: Bristol Myers-Squibb Belgium:
Reimbursable since April 1997
  Active
Ingredient
Dosage form;
Route
 Strength
Powder for Reconstitution 1mg/ml Stavudine Capsule; Oral  30MG
Stavudine Capsule; Oral  40MG
Stavudine Powder For Reconstitution; Oral  1MG/ML 

back to topPharmacokinetics

The absorption and serum concentrations of stavudine are not affected by meals and its active metabolite has an intracellular half-life of approximately 4 hours. Because the drug is cleared by the kidneys, the dose should be modified in patients with reduced creatinine clearance. (106)

back to topDosing

The recommended dosage of stavudine is 40 mg twice daily for patients weighing more than 60 kg and 30 mg twice daily for patients weighing less than 60 kg. The drug should be given every 12 hours. (106)

Pediatric Dose:


back to topSide effects

Stavudine is safe and well tolerated. The major clinical toxicity is peripheral neuropathy. The etiology of stavudine-related neuropathy appears different from that related to didanosine or zalcitabine. (100) In a large study comparing zidovudine with stavudine, the incidence of peripheral neuropathy in the stavudine-treated group was 14%.(124) In general, the incidence of neuropathy increases significantly as the CD4+ T-cell count declines. Symptoms typically resolve if the drug is discontinued promptly. Once symptoms have resolved, rechallenging the patient at lower doses (20 mg twice daily) may be considered. (106)
Other adverse events with stavudine are rare. Mild to modest nausea, vomiting, myalgias, headaches, and fatigue have been reported. The occurrence of clinical pancreatitis in patients receiving stavudine has been rare. (106,125)

back to topDrug interactions

Because stavudine has been shown to cause peripheral neuropathy, medications associated with the development of neuropathy should be avoided during stavudine therapy. (114)
 

Interactions with other antiretroviral agents 
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