Valganciclovir


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Cytomegaloviral retinitis in AIDS patients Induction: 900 mg bid for 21 days. Maintenance: 900 mg once daily. Prophylaxis of cytomegaloviral infections in immunocompromised patients 900 mg once daily starting w/in 10 days and continuing until 100 days post-transplantation, or up to 200 days for kidney transplant.
Dosage Details
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.

Oral
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.
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.
Reconstitution
Add 91 mL of purified water to provide a soln containing 250 mg per 5 mL. Tap the bottle to loosen the powder, then add water in 2 approx equal portions. Shake the bottle for 1 min after each addition.
Contraindications
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.
Special Precautions
Patient w/ pre-existing haematological cytopenia, history of drug-related haematological cytopenia. Renal impairment. Pregnancy.
Adverse Reactions
Abdominal pain, diarrhoea, graft rejection, increased serum creatinine, headache, insomnia, nausea, paraesthesia, peripheral neuropathy, pyrexia, retinal detachment, tremors, vomiting.
Potentially Fatal: Severe leucopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow depression, aplastic anaemia, acute renal failure.
Patient Counseling Information
May impair ability to drive or operate machinery. Avoid direct contact of broken or crushed tab w/ skin or mucous membranes.
MonitoringParameters
Monitor CBC w/ differential, platelet count, serum creatinine.
Overdosage
Symptoms: Bone marrow depression (medullary aplasia), renal toxicity. Management: Maintain adequate hydration. May consider use of hematopoietic factors. Dialysis may be useful in reducing serum concentrations.
Drug 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.
Food Interaction
Food increases absorption.
Action
Description: 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.
Pharmacokinetics:
Absorption: Well absorbed from the GI tract. Increased absorption if taken w/ food. Bioavailability: Approx 60%. Time to peak plasma concentration: 1-3 hr.
Distribution: Widely distributed to all tissue including CSF and ocular tissue.
Metabolism: Converted to ganciclovir by rapid first-pass intestinal or hepatic metabolism.
Excretion: Via urine as ganciclovir.
Storage
Tab: Store at 25°C. Oral soln: Store at 25°C (dry powder); 2-8°C (after reconstitution).
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Valganciclovir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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