Product Information
Registration Status: ActiveSIN13304P
SEBIVO TABLET 600MG is approved to be sold in Singapore with effective from 2007-06-22. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN13304P.
This product contains Telbivudine 600mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Novartis Pharma Stein AG in SWITZERLAND, andS.C. Sandoz S.R.L. in ROMANIA.
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
Telbivudine is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Telbivudine is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.
Indication
For the treatment of chronic hepatitis B in adult and adolescent patients ≥16 years of age with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Mechanism of Action
Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. This leads to the chain termination of DNA synthesis, thereby inhibiting viral replication. Incorporation of telbivudine 5'–triphosphate into viral DNA also causes DNA chain termination, resulting in inhibition of HBV replication. Telbivudine inhibits anticompliment or second-strand DNA.
Pharmacokinetics
- Absorption
- Absorbed following oral administration. Telbivudine absorption and exposure were unaffected when a single 600–mg dose was administered with a high–fat (~55 g), high–calorie (~950 kcal) meal.
- Distribution
- Metabolism
- No metabolites of telbivudine were detected following administration of [14C]–telbivudine in humans. Telbivudine is not a substrate, or inhibitor of the cytochrome P450 (CYP450) enzyme system.
- Elimination
Clearance
* 7.6 +/- 2.9 L/h [Normal renal function (Clcr>80 mL/min)] * 5.0 +/- 1.2 L/h [Mild renal function impairement (Clcr=50-80 mL/min)] * 2.6 +/- 1.2 L/h [Moderate renal function impairement (Clcr=30-49 mL/min)] * 0.7 +/- 0.4 L/h [Severe renal function impairement (Clcr
Toxicity
There is no information on intentional overdose of telbivudine, but one subject experienced an unintentional and asymptomatic overdose. Healthy subjects who received telbivudine doses up to 1800 mg/day for 4 days had no increase in or unexpected adverse events. A maximum tolerated dose for telbivudine has not been determined.
Active Ingredient/Synonyms
1-(2-Deoxy-beta-L-ribofuranosyl)-5-methyluracil | 2'-Deoxy-L-thymidine | beta-L-2'-Deoxythymidine | Beta-l-thymidine | Epavudine | L-deoxythymidine | L-DT | L-thymidine | LDT | Telbivudin | Telbivudine |
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.