Didanosine how supplied
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
HOW SUPPLIED/STORAGE AND HANDLING
VIDEX (didanosine, USP) Pediatric Powder for Oral Solution is supplied as shown in Table 15:
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Prior to dispensing, the pharmacist must reconstitute dry powder with Purified Water, USP, to an initial concentration of 20 mg/mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg/mL as follows:
20 mg/mL Initial Solution
Reconstitute the product to 20 mg/mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g or 4 g of VIDEX powder, respectively, in the product bottle.
10 mg/mL Final Admixture
Immediately mix one part of the 20 mg/mL initial solution with one part of Maximum Strength Mylanta® Liquid for a final dispensing concentration of 10 mg VIDEX per mL. For patient home use, the admixture should be dispensed in appropriately sized, flint-glass or plastic (HDPE, PET, or PETG) bottles with child-resistant closures. Instruct the patient to shake the admixture thoroughly prior to use and to store the tightly closed container in the refrigerator.
Storage
The bottles of powder should be stored at 59° F to 86° F (15° C to 30° C). The VIDEX admixture may be stored up to 30 days in a refrigerator, 36° F to 46° F (2° C to 8° C). Discard any unused portion after 30 days
References
Adapted from the FDA Package Insert.