TAMIFLU CAPSULE 45MG

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.

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 |

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.

Pharmacodynamics

Oseltamivir is an antiviral drug, a neuraminidase inhibitor used in the treatment and prophylaxis of both influenza A and influenza B. Oseltamivir is a prodrug (usually administered as phosphate), it is hydrolysed hepatically to the active metabolite, the free carboxylate of oseltamivir (GS4071). Like zanamivir, oseltamivir acts as a transition-state analogue inhibitor of influenza neuraminidase.

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:

Absorbed oseltamivir is primarily (>90%) eliminated by conversion to oseltamivir carboxylate. Oseltamivir carboxylate is not further metabolized and is eliminated in the urine. Oseltamivir carboxylate is eliminated entirely (>99%) by renal excretion.

Half-life

1 to 3 hours in most subjects after oral administration.

Clearance

Not Available

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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

TAMIFLU CAPSULE 45MG was registered with Health Science Authority of Singapore by ROCHE SINGAPORE PTE LTD. It is marketed with the registration number of SIN13507P with effective from 2008-07-31.

This product contains 45mg of Oseltamivir in the form of CAPSULE.

The medicine was manufactured by F. Hoffmann-La Roche Ltd Roche S.p.A. in SWITZERLAND, and in ITALY

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: J05AH02

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1 DEXTROMETHORPHAN LINCTUS 15mg/5ml Dextromethorphan P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
22 ZENMOLIN SYRUP 2mg/5ml Salbutamol P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
41 APO-PROPRANOLOL TABLET 40mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
42 APO-DIAZEPAM TABLET 2mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
44 APO-DIAZEPAM TABLET 5mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
45 APO-DIAZEPAM TABLET 10mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
46 APO-PROPRANOLOL TABLET 10mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
55 APO-ISDN TABLET 10mg Isosorbide Dinitrate POM PHARMAFORTE SINGAPORE PTE LTD Active
63 DIAPO TABLET 10mg Diazepam POM BEACONS PHARMACEUTICALS PTE LTD Active
64 FURMIDE TABLET 40mg Furosemide POM BEACONS PHARMACEUTICALS PTE LTD Active

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5 DIPHENHYDRAMINE EXPECTORANT PAED. Ammonium Chloride|Diphenhydramine|Sodium Citrate P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
400 FAKTU SUPPOSITORY Cinchocaine|Policresulen P Only TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE LTD Active
407 TRIMAXAZOLE TABLET Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
435 APO-SULFATRIM TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
508 APO-SULFATRIM PEDIATRIC TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
526 B.S. SUSPENSION Sulfamethoxazole|Trimethoprim POM APEX PHARMA MARKETING PTE LTD Active
583 CO-TRIMEXAZOLE SUSPENSION Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
676 BANEOCIN OINTMENT Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
678 BANEOCIN POWDER Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
706 TIENAM 500 FOR INJECTION Imipenem|Cilastatin POM MSD PHARMA (SINGAPORE) PTE LTD Active