Didanosine indications and usage
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Indications And Usage
VIDEX® (didanosine, USP), also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].
Dosage and Administration
VIDEX should be administered on an empty stomach, at least 30 minutes before or 2 hours after eating.
Recommended Dosage (Adult and Pediatric Patients)
The preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing regimen. Once-daily dosing should be considered only for patients whose management requires once-daily dosing of VIDEX [see Clinical Studies (14)]. The recommended adult total daily dose is based on body weight (kg) (see Table 1).
- ::Adult Patients
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- ::Pediatric Patients
(2 weeks old to 18 years old): The recommended dose of VIDEX (didanosine) in pediatric patients between 2 weeks old and 8 months old is 100 mg/m2 twice daily, and the recommended VIDEX dose for pediatric patients greater than 8 months old is 120 mg/m2 twice daily but not to exceed the adult dosing recommendation.
Dosing recommendations in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose. There are no data on once-daily dosing of VIDEX in pediatric patients.
Renal Impairment
- Adult Patients
In adult patients with impaired renal function, the dose of VIDEX should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX in adult patients with renal insufficiency are presented inTable 2.
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References
Adapted from the FDA Package Insert.