Composition
Each tablet contains stavudine 30 mg and excipients q.s. (microcrystalline cellulose, pregelatinized starch, crosscarmellose sodium, magnesium stearate).

Dosage form
Tablets.

Presentation
Box of 1 bottle x 60 tablets.

Indications
Treatment of HIV-AIDS. Stavudine in combination with other antiretroviral agents is indicated for treatment of HIV infection.

Contra-indications
Hypersensitivity to stavudine or to any of its ingredients.

Precautions
Patients should be informed of the importance of early recognition of symptoms of symptomatic hyperlactatemia or lactic acidosis syndrome, which include unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, and motor weakness. Patients in whom these symptoms develop should seek medical attention immediately. Discontinuation of stavudine therapy may be required.
Patients should be informed that an important toxicity of stavudine is peripheral neuropathy. Patients should be aware that peripheral neuropathy is manifested by numbness, tingling, or pain in hands or feet, and that these symptoms should be reported to their physicians. Patients should be counseled that peripheral neuropathy occurs with greatest frequency in patients who have advanced HIV disease or a history of peripheral neuropathy, and that dose modification and/or discontinuation of stavudine may be required if toxicity develops.
Patients should be informed that when stavudine is used in combination with other agents with similar toxicities, the incidence of adverse events may be higher than when stavudine is used alone. An increased risk of pancreatitis, which may be fatal, may occur in patients treated with the combination of stavudine and didanosine, with or without hydroxyurea. Patients treated with this combination should be closely monitored for symptoms of pancreatitis. An increased risk of hepatotoxicity, which may be fatal, may occur in patients treated with stavudine in combination with didanosine and hydroxyurea. This combination should be avoided.
Pediatric Use: Use of stavudine in pediatric patients from birth through adolescence is supported by evidence from adequate and well-controlled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients.
Geriatric Use: Stavudine is known to be substantially excreted by the kidney, and elderly patients are more likely to have decreased renal function, dose adjustment is recommended for geriatric patients.

Use in pregnancy and lactation
Use in pregnancy: Stavudine should be used during pregnancy only if the potential benefits outweigh the risks. Patients who receiving stavudine during pregnancy or being pregnant should immediately inform to the physician. Use in lactation: Mothers who are receiving stavudine should discontinue breast-feeding.

Side effect
Lactic Acidosis: Lactic acidosis and severe hepatomegaly with steatosis have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals (didanosine, hydroxyurea). The symptoms that may indicate a liver problem may include: feeling very weak, tired, or uncomfortable; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or lightheaded; suddenly developing a slow or irregular heartbeat. Women, overweight patients, and those who have had lengthy treatment with nucleoside medicines are more likely to develop lactic acidosis.
Peripheral neuropathy: This nerve disorder is rare, but may be serious.
Peripheral neuropathy manifested by numbness, tingling, or pain in the feet or hands has been reported in patients receiving stavudine therapy. Peripheral neuropathy has occurred more frequently in patients with advanced HIV disease, a history of neuropathy, or concurrent neurotoxic drug therapy, including didanosine.
Pancreatitis: Pancreatitis is a dangerous inflammation of the pancreas. It may cause death. Its symptoms include: stomach pain, nausea and vomiting.
Liver : symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis, hepatitis and liver failure.
Others side effects: In addition to peripheral neuropathy, the most frequent side effects observed in studies of adults taking the recommended dose of stavudine were headache, diarrhea, rash, and nausea and vomiting. Others side effects may include abdominal pain, muscle pain, insomnia, loss of appetite, chills or fever, allergic reactions, and blood disorders.
Inform your doctor any side effect occur during therapy

Drug interaction
Drug interation studies have demonstrated that there are no clinically significant interactions between stavudine and the following: didanosine, lamivudine, or nelfinavir.
Zidovudine may competitively inhibit the intracellular phosphorylation of stavudine. Therefore, use of zidovudine in combination with stavudine is not recommended.

Dosage and administration: The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food
Adults: 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.
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.
Patients with peripheral neuropathy:
            20 mg twice daily for patients ≥  60 kg
            15 mg twice daily for patients < 60 kg
Renal Impairment:

Creatinine Clearance ( mL/min)	Recommended stavudine dose by patient weight	Recommended stavudine 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

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.

Shelf-life: 24 months.

Storage: Store in a dry and cool place, below 30 degree C. Keep out of reach of children.

Prescription only medicine
Read leaflet carefully before use
For more information, consult your physician.