Therapeutic Category:

Anti-retroviral reverse transcriptase inhibitor.


Position:

STADINE-30STADINE-40
Each capsule contains Stavudine 30 mgEach capsule contains Stavudine 40 mg

Indications:

Treatment of human immunodeficiency virus (HIV) infection.


Adverse Reactions:

Peripheral neuropathy, arthralgia, hypersensitivity, myalgia, anemia, panceatitis


Warnings:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. Fatal and nonfatal pancreatitis have been reported during therapy in combination with didanosine.


Precautions:

Pregnancy:
Category C: Lactation: Lamivudine treated mothers should be instructed to discontinue breast-feeding;
Elderly: likely to have an age related decrease in renal function, which may require dose reduction.


Drug Interactions:

Zidovudine may competitively inhibit the intracellular phos-phorylation of stavudine. Thus STADINE should not be used in combination with zidovudine.


Contraindications:

Hypersensitivity to any of the components of the formulation;


Dosage And Administration:

May be taken without regard to meals. Adults: Body weight = 60kg = Stadine-40 mg twice daily; Body weight <60 kg = Stadine-30 mg twice daily. CrCl 26-50 ml/min, =60kg = 20 mg twice daily; CrCl 26-50 ml/min, <60kg = 15 mg twice daily; CrCl- 10-25ml/min, =60kg = 20mg once daily; CrCl- 10-25ml/min, <60kg = 15mg once daily.


Storage:

Stavudine capsules should be stored in tightly closed containers at controlled room temperature, 59° to 86°F (15° to 30°C).