Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
VALGANCICLOVIR HYDROCHLORIDE (UNII: 4P3T9QF9NZ) (GANCICLOVIR - UNII:P9G3CKZ4P5)
American Health Packaging
ORAL
PRESCRIPTION DRUG
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)]. Prevention of CMV Disease: Valganciclovir for oral solution is 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)]. Prevention of CMV Disease: Valganciclovir for oral solution is 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)]. Valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adv
Valganciclovir 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 60687-765-13). Prior to dispensing to the patient, valganciclovir for oral solution must be prepared by the pharmacist [see Dosage and Administration (2.4)]. Store dry powder at 20°C to 25°C (68°F to 77°F); excursions are 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.
Abbreviated New Drug Application
VALGANCICLOVIR- VALGANCICLOVIR HYDROCHLORIDE POWDER, FOR SOLUTION AMERICAN HEALTH PACKAGING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALGANCICLOVIR FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR FOR ORAL SOLUTION INITIAL U.S. APPROVAL: 2001 WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HEMATOLOGIC TOXICITY: SEVERE LEUKOPENIA, NEUTROPENIA, ANEMIA, THROMBOCYTOPENIA, PANCYTOPENIA, AND BONE MARROW FAILURE INCLUDING APLASTIC ANEMIA HAVE BEEN REPORTED IN PATIENTS TREATED WITH VALGANCICLOVIR. (5.1) IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA, VALGANCICLOVIR MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF SPERMATOGENESIS IN MALES AND SUPPRESSION OF FERTILITY IN FEMALES. (5.3) FETAL TOXICITY: BASED ON ANIMAL DATA, VALGANCICLOVIR HAS THE POTENTIAL TO CAUSE BIRTH DEFECTS IN HUMANS. (5.4) MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, VALGANCICLOVIR HAS THE POTENTIAL TO CAUSE CANCERS IN HUMANS. (5.5) INDICATIONS AND USAGE Valganciclovir is 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. DOSAGE AND ADMINISTRATION ADULT DOSAGE(2.2) Treatment of CMV retinitis Induction: 900 mg (two 450 mg tablets) twice a day for 21 days Maintenance: 900 mg (two 450 mg tablets) once a day Prevention of CMV disease in heart or kidney- pancreas transplant patients 900 mg (two 450 mg tablets) once a day within 10 days of transplantation until 100 days post-transplantation Prevention of CMV disease in kid read_full_document