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Stavudine information from DrugsUpdate  

See Available Brands of Stavudine in India

P - Caution when used during pregnancy
L - Contraindicated in lactation

Stavudine (2'-3'-didehydro-2'-3'-dideoxythymidine, d4T, brand name Zerit) is a nucleoside analog reverse transcriptase inhibitor (NARTI) active against HIV.

Pharmacodynamics

Pharmacokinetics

Stavudine is converted intracellularly to the active metabolite stavudine 5'-triphosphate which is then incorporated into the viral DNA by reverse transcriptase resulting in premature ending of the DNA chain elongation.

Absorption
Rapidly absorbed from the GI tract after oral admin, food may delay its absorption; peak plasma concentrations within 1 hour.

Distribution

Crosses the blood-brain barrier and negligible plasma protein binding.

Metabolism

Intracellular; converted to the active antiviral triphosphate.

Excretion

Urine (about 40%); 1.5 hours (elimination half-life).

Stavudine Indications / Stavudine Uses

Information Not Available

Stavudine Adverse Reactions / Stavudine Side Effects

Headache, nausea, vomiting, asthenia, chest pain, influenza-like syndrome, insomnia, abdominal pain, anorexia, neutropenia, thrombocytopenia, arthralgia, myalgia, mood changes, dyspnoea, pharyngitis, skin rashes, pruritus.

Precautions

Warnings
Pancreatitis

Fatal and nonfatal cases have occurred in combination with didanosine with or without hydroxyurea.

Lactic Acidosis and Hepatomegaly

Reported with steatosis (including fatal cases) with the use of nucleoside analogues alone or in combination. Reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Use the combination with caution in pregnant women.

Overdosage
Chronic overdosage may lead to peripheral neuropathy and hepatic toxicity.

Special Precautions

Hepatomegaly or other risk factors for liver disease. History of peripheral neuropathy and renal impairment. Pregnancy. Discontinue treatment if peripheral neuropathy develops; may resume treatment at half the previous dose if symptoms resolve upon drug withdrawal. Monitor for signs of pancreatitis. Discontinue treatment if there is a rapid increase in aminotransferase concentrations, progressive hepatomegaly or steatosis, or metabolic or lactic acidosis. Increased risk of severe and fatal hepatic adverse events in patients with chronic hepatitis B or C treated with combination antiretroviral therapy.

Other Drug Interactions

Antiviral effect inhibited by zidovudine, doxorubicin and ribavirin. Avoid concurrent admin with drugs that cause pancreatitis (e.g. IV pentamidine) or peripheral neuropathy (e.g. metronidazole, isoniazid and vincristine). Increased risk of adverse effects such as hepatoxicity, peripheral neuropathy and pancreatitis if used with hydroxycarbamide and didanosine.

Other Interactions

Information Not Available

Dosage

Oral
HIV infection
Adult: <60: 30 mg; ≥60 kg: 40 mg. Doses to be taken every 12 hours.
Child: From birth-13 days old: 500 mcg/kg; ≥14 days old and weighing <30 kg: 1 mg/kg; 30 kg-<60 kg: 30 mg; ≥60 kg: 40 mg. Doses to be taken every 12 hours.


CrCl (ml/min)    Dosage Recommendation


26-50               <60 kg: 15 mg; ≥60 kg: 20 mg. Doses to be taken every 12 hours.
<25                  <60 kg: 15 mg; ≥60 kg: 20 mg. Doses to be taken every 24 hours.

Food(before/after)

May be taken with or without food

List of Contraindications

Stavudine and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Stavudine and Lactation

Contraindicated in lactation

Stavudine and Children

Safety and efficacy of extended-release dosage form not established

Stavudine and Geriatic

Clinical studies of stavudine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Greater sensitivity of some older individuals to the effects of stavudine cannot be ruled out.

Stavudine and Other Contraindications

Hypersensitivity. Lactation

Storage

Oral
Store at 25°C

Lab interference

Oral
Store at 25°C

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