Product Information
Registration Status: ActiveVALGANCICLOVIR SANDOZ FILM COATED TABLET 450MG is approved to be sold in Singapore with effective from 2020-08-07. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN15985P.
This product contains Valganciclovir 450mg in the form of TABLET, FILM COATED. It is approved for ORAL use.
This product is manufactured by Bluepharma - Indústria Farmacêutica in PORTUGAL.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Valganciclovir hydrochloride (Valcyte, manufactured by Roche) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.
Indication
Valganciclovir is an antiviral medication used for the treatment of cytomegalovirus infections.
Mechanism of Action
Valganciclovir is a prodrug of ganciclovir that exists as a mixture of two diastereomers. After administration, these diastereomers are rapidly converted to ganciclovir by hepatic and intestinal esterases. In cytomegalovirus (CMV)-infected cells, ganciclovir is initially phosphorylated to the monophosphate form by viral protein kinase, then it is further phosphorylated via cellular kinases to produce the triphosphate form. This triphosphate form is slowly metabolized intracellularly. The phosphorylation is dependent upon the viral kinase and occurs preferentially in virus-infected cells. The virustatic activity of ganciclovir is due to the inhibition of viral DNA synthesis by ganciclovir triphosphate. Ganciclovir triphosphate is incorporated into the DNA strand replacing many of the adenosine bases. This results in the prevention of DNA synthesis, as phosphodiester bridges can longer to be built, destabilizing the strand. Ganciclovir inhibits viral DNA polymerases more effectively than it does cellular polymerase, and chain elongation resumes when ganciclovir is removed.
Pharmacokinetics
- Absorption
- Valganciclovir is well absorbed from the gastrointestinal tract and the absolute bioavailability from valganciclovir tablets (following administration with food) is approximately 60%.
- Distribution
- * 0.703 ± 0.134 L/kg
- Metabolism
- Rapidly hydrolyzed in the intestinal wall and liver to ganciclovir. No other metabolites have been detected.
- Elimination
Clearance
* 3.07+/- 0.64 mL/min/kg [IV administration] * 5.3 L/hr [Patient with creatinine clearance of 70.4 mL/min]
Toxicity
It is expected that an overdose of valganciclovir could also possibly result in increased renal toxicity.
Active Ingredient/Synonyms
Cymeval | L-valine, ester with ganciclovir | Valganciclovir | Valganciclovir |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.