LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
ANTIRETROVIRAL NUCLEOSIDE ANALOGUES ALONE OR
IN COMBINATION, INCLUDING STAVUDINE (SEE WARNINGS).
ZERIT is the brand name for stavudine
(formerly called d4T), a synthetic thymidine nucleoside
analogue, active against the Human Immunodeficiency Virus (HIV).
ZERIT ® (stavudine) Capsules are supplied for oral
administration in strengths of 15, 20, 30, and 40 mg
of stavudine. Each capsule
also contains inactive ingredients microcrystalline
starch glycolate, lactose,
and magnesium stearate.
The hard gelatin shell
consists of gelatin, methylparaben, propylparaben, titanium
dioxide, and iron oxides.
ZERIT (stavudine) for Oral Solution is supplied as a dye-free,
fruit-flavored powder in bottles with child-resistant closures providing
200 mL of a 1 mg/mL stavudine
solution upon constitution
with water per
label instructions. The
powder for oral
solution contains the
following inactive ingredients: methylparaben, propylparaben, sodium
carboxymethylcellulose, sucrose, and antifoaming and flavoring agents.
The chemical name
for stavudine is 2,3-didehydro-3-deoxythymidine.
Stavudine is a white to
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.