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Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
Prevention of CMV Disease: Valganciclovir tablets USP are indicated for the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)].
Prevention of CMV Disease: Valganciclovir tablets USP are indicated for the prevention of CMV disease in kidney or heart transplant patients (4 months to 16 years of age) at high risk [see Clinical Studies (14.2)].
Valganciclovir tablet USP is not indicated for use in either adult or pediatric liver transplant patients [see Clinical Studies (14.1, 14.2)].
The safety and efficacy of valganciclovir tablets USP have not been established for:
- Prevention of CMV disease in solid organ transplants other than those indicated [see Clinical Studies ( 14.1, 14.2)].
- Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age [see Clinical Studies (14.2)].
- Treatment of congenital CMV disease [see Use in Specific Populations (8.4)]
There is currently no drug history available for this drug.
Valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.
Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film-coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide.
Valganciclovir hydrochloride USP is a white to almost white powder with a molecular formula of C14H22N6O5·HCl and a molecular weight of 390.71. The chemical name for valganciclovir hydrochloride USP is L-Valine, 2[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride USP is a polar hydrophilic compound with a saturation solubility of 6029 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.00701 at pH 5.1. The pKa for valganciclovir hydrochloride USP is 7.2.
The chemical structure of valganciclovir hydrochloride USP is:
All doses in this insert are specified in terms of valganciclovir.