Valganciclovir hydrochloride how supplied
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
How Supplied
Valcyte Tablets: Supplied as 450 mg, pink, convex oval tablets with "VGC" on one side and "450" on the other side. Each tablet contains valganciclovir HCl equivalent to 450 mg valganciclovir. Valcyte is supplied in bottles of 60 tablets (NDC 0004-0038-22).
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].
Valcyte for Oral Solution: Supplied as a white to slightly yellow powder blend for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution. Available in glass bottles containing approximately 100 mL of solution after constitution. Each bottle can deliver up to a total of 88 mL of solution. Each bottle is supplied with a bottle adapter and 2 oral dispensers (NDC 0004-0039-09).
Prior to dispensing to the patient, Valcyte for oral solution must be prepared by the pharmacist [see Dosage and Administration (2.4)].
Store dry powder at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].
Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.