valganciclovir 450 MG Oral Tablet
1 INDICATIONS & USAGE Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) • Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). • Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2 ) • Prevention of CMV disease in kidney and heart transplant patients at high risk 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets 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 are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies ( 14.1 )]. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2 )].
camber pharmaceuticals, inc.
OVAL PINK J 156
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING
VALGANCICLOVIR tablets USP, 450 mg are pink, oval, biconvex, film-coated tablets, debossed with 'J' on one side and '156' on the other side. Each film-coated tablet contains 496.3 mg of
VALGANCICLOVIR hydrochloride, USP equivalent to 450 mg of
VALGANCICLOVIR.
VALGANCICLOVIR tablets are supplied in: Bottles of 60 tablets NDC 31722-832-60 Blister card of 10 Unit dose tablets NDC 31722-832-31 Blister pack of 100 (10 x 10) Unit dose tablets NDC 31722-832-32 Store at 25 o C; excursions permitted between 15 o and 30 o C (59 o and 86 o F). [See USP Controlled Room Temperature.]
More pills like OVAL J 156