FATAL AND NONFATAL PANCREATITIS HAS OCCURRED DURING THERAPY WITH
VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE
AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION.
VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH; SUSPECTED PANCREATITIS
AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS).
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL ASES, HAVE BEEN EPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES
ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS
VIDEX is the brand name for didanosine (ddI), a synthetic purine nucleoside
analogue active against the Human Immunodeficiency Virus (HIV). VIDEX
Chewable/Dispersible Buffered Tablets are available for oral administration
in strengths of 25, 50, 100, 150, and 200 mg of didanosine. Each tablet
is buffered with calcium carbonate and magnesium hydroxide. VIDEX tablets
also contain aspartame, sorbitol, microcrystalline cellulose, polyplasdone,
mandarin-orange flavor and magnesium stearate.
VIDEX Buffered Powder for Oral Solution is supplied for oral administration
in single-dose packets containing 100, 167, or 250 mg of didanosine. Packets
of each product strength also contain a citrate-phosphate buffer (composed
of dibasic sodium phosphate, sodium citrate, and citric acid) and sucrose.
VIDEX Pediatric Powder for Oral Solution is supplied for oral administration
in 4- or 8-ounce glass bottles containing 2 or 4 grams of didanosine,
The chemical name for didanosine is 2',3'-dideoxyinosine.
Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
and a molecular weight of 236.2. The aqueous solubility of didanosine
at 25C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable
in acidic solutions. For example, at pH <3 and 37C, 10% of didanosine
decomposes to hypoxanthine in less than 2 minutes.