Product Information
Registration Status: ActiveSIN11403P
TAMIFLU CAPSULE 75mg is approved to be sold in Singapore with effective from 2000-10-14. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN11403P.
This product contains Oseltamivir 75mg in the form of CAPSULE. It is approved for ORAL use.
This product is manufactured by Delpharm Milano S.r.l. in ITALY,CENEXI SAS in FRANCE, andCatalent Germany Schorndorf GmbH in GERMANY.
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
An acetamido cyclohexene that is a structural homolog of sialic acid and inhibits neuraminidase. [PubChem]
Indication
Oseltamivir (Tamiflu) is for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. It is also used for the prophylaxis of influenza in adult patients and adolescents 13 years and older.
Mechanism of Action
Oseltamivir is an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, oseltamivir carboxylate. The proposed mechanism of action of oseltamivir is inhibition of influenza virus neuraminidase with the possibility of alteration of virus particle aggregation and release.
Pharmacokinetics
- Absorption
- Readily absorbed from the gastrointestinal tract after oral administration with a bioavailability of 75%.
- Distribution
- * 23 to 26 L
- Metabolism
- Extensively converted to oseltamivir carboxylate by esterases located predominantly in the liver. Neither oseltamivir nor oseltamivir carboxylate is a substrate for, or inhibitor of, cytochrome P450 isoforms. At least 75% of an oral dose reaches the systemic circulation as oseltamivir carboxylate.
- Elimination
Toxicity
At present, there has been no experience with overdose. Single doses of up to 1000 mg of oseltamivir have been associated with nausea and/or vomiting. Mean LD (intravenous, mouse) = 100 mg/kg.
Active Ingredient/Synonyms
(−)-oseltamivir | 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, ethyl ester, (3R-(3alpha,4beta,5alpha))- | Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate | Oseltamivir | oséltamivir | Oseltamivirum | Oseltamivir |
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.