Hetero Labs


Concise Prescribing Info
Valganciclovir HCl
Induction & maintenance treatment of cytomegalovirus (CMV) retinitis in patients w/ AIDS. Prevention of CMV disease in CMV -ve patients who have received solid organ transplant from a CMV +ve donor.
Dosage/Direction for Use
Adult Active CMV retinitis 900 mg bid for 21 days. Inactive CMV retinitis 900 mg once daily. Prevention of CMV disease in solid organ transplantation 900 mg once daily starting w/in 10 days of transplant & 100 days post-transplant. May be continued until 200 days post-transplant for kidney transplant patients. Induction dose Renal impairment CrCl ≥60 mL/min 900 mg bid, 40-59 mL/min 450 mg bid, 25-39 mL/min 450 mg once daily, 10-24 mL/min 450 mg every 2 days. Maintenance/prevention dose CrCl ≥60 mL/min 900 mg once daily, 40-59 mL/min 450 mg once daily, 25-39 mL/min 450 mg every 2 days, 10-24 mL/min 450 mg twice wkly.
Should be taken with food: Swallow whole, do not break/crush.
Hypersensitivity to valganciclovir, ganciclovir, aciclovir & valaciclovir. Lactation.
Special Precautions
Fetotoxicity. Teratogenic & carcinogenic. May cause temporary or permanent inhibition of spermatogenesis. Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression & aplastic anemia. Possible risk of developing leucopenia & neutropenia when extending prophylaxis beyond 100 days. Preexisting hematological cytopenia or history of drug-related hematological cytopenia & in patients receiving radiotherapy. Monitor complete blood & platelet counts. Should not be used in dialysis patients. Convulsions. Closely monitor signs of added toxicity when concomitantly used w/ didanosine, zidovudine or substances affecting renal function. Impaired renal function. May affect ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Severe neutropenia, anemia; dyspnea; diarrhea.
Drug Interactions
Decreased renal clearance & increased exposure w/ probenecid & other nucleoside analogues. Increased AUC of zidovudine. Increased plasma conc of didanosine. Increased in phenolic glucuronide of mycophenolic acid (MPAG) & ganciclovir concentration w/ oral mycophenolate mofetil. Potential enhancement of toxicity w/ trimethoprim. Synergistic or antagonistic effect w/ other antiretrovirals. Enhanced toxicity w/ dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulpha combinations, nucleoside analogues & hydroxyurea. Imipenem-cilastatin.
MIMS Class
ATC Classification
J05AB14 - valganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Valvir-450 FC tab 450 mg
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