Valcyte Tablet

Valganciclovir

450mg

ROCHE Pharma

Pack size
Dispensing mode
Source
Agent
Retail Price	1910.14 NPR

Indications

Valcyte Tablet is used for: Cytomegalovirus infections

Adult Dose

Oral Cytomegaloviral retinitis in AIDS patients Adult: Induction: 900 mg bid for 21 days. Maintenance: 900 mg once daily. May repeat induction if retinitis deteriorates during maintenance but the possibility of viral resistance should be considered. Prophylaxis of cytomegaloviral infections in immunocompromised patients Adult: 900 mg once daily starting w/in 10 days and continuing until 100 days after transplantation, may continue until 200 days for kidney transplant. CMV Prevention in Solid Organ Transplant 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-]) Kidney transplantation 900 mg PO qDay Begin within 10 days of transplant until 200 days post-transplant Kidney-pancreas transplantation 900 mg PO qDay Begin within 10 days of transplant until 100 days posttransplant Heart transplantation 900 mg PO qDay Begin within 10 days of transplant until 100 days posttransplant

Child Dose

CMV Prevention in Kidney & Heart Transplant Kidney transplantation <4 months: Safety and efficacy not established 4 months to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day Begin within 10 days of transplant and continue until 200 days post-transplant Heart transplantation <1 month: Safety and efficacy not established 1 month to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day Begin within 10 days of transplant and continue until 100 days post-transplant

Renal Dose

Renal Impairment CrCl Dosage <10 and haemodialysis patients Not recommended. 10-24 450 mg every 2 days (or 225 mg once daily) for induction; 450 mg twice wkly (or 125 mg once daily) for maintenance. 25-39 450 mg once daily for induction; 450 mg every 2 days (or 225 mg once daily) for maintenance. 40-59 450 mg bid for induction; 450 mg once daily for maintenance. >60 900 mg bid for induction; 900 mg once daily for maintenance.

Administration

Should be taken with food. Take during or immediately after meals.

Contra Indications

Hypersensitivity. Haemodialysis patients (CrCl <10 mL/min). Lactation. Should not be administered if the absolute neutrophil count is <500 cells/μL, platelet count is <25,000/μL, or Hb is <8 g/dL.

Precautions

Patient w/ pre-existing haematological cytopenia, history of drug-related haematological cytopenia. Renal impairment. Pregnancy. Lactation: not known if distributed in breast milk; do not nurse

Pregnancy-Lactation

Interactions

Convulsions may occur if taken concomitantly w/ imipenem-cilastatin. Increased exposure w/ probenecid. Increased risk of neutropenia and anaemia w/ zidovudine. May increase plasma concentrations of didanosine. Increased risk of neutropenia and leucopenia w/ mycophenolate mofetil. Increased risk of peripheral neuropathy w/ zalcitabine. Enhanced toxicity w/ other drugs that inhibit replication of rapidly dividing cells (e.g. dapsone, vincristine, vinblastine, amphotericin B, trimethoprim/sulfa combinations, nucleoside analogues, hydroxyurea), cidofovir, foscamet.

Adverse Effects

Side effects of Valganciclovir : >10% Abdominal pain (15%),Anemia (8-26%),Diarrhea (16-41%),Fever (31%),Granulocytopenia (11-27%),Headache (9-22%),Insomnia (16%),Nausea (8-30%),Retinal detachment (15%),Vomiting (21%) 1-10% Peripheral neuropathy (9%),Paresthesia (8%),Seizures (<5%),Psychosis, hallucinations (<5%),Confusion (<5%),Agitation (<5%),Thrombocytopenia (8%),Pancytopenia (<5%),Bone marrow depression (<5%),Aplastic anemia (<5%),Bleeding, potentially life-threatening due to thrombocytopenia (<5%),Decr renal function (<5%),,Local & systemic infections, incl sepsis (<5%),Allergic reaction (<5%)

Mechanism of Action

Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of 2 diastereomers. After oral admin, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human cytomegalovirus (CMV) in cell culture and in vivo.

Note

Valcyte 450mg Tablet manufactured by ROCHE Pharma. Its generic name is Valganciclovir. Valcyte is availble in Nepal. Farmaco Nepal drug index information on Valcyte Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.