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FENAGESIC-500 TABLET 500mg

Product Information

Registration Status: Active

SIN05718P

FENAGESIC-500 TABLET 500mg is approved to be sold in Singapore with effective from 1991-08-04. It is marketed by SUNWARD PHARMACEUTICAL PTE LTD, with the registration number of SIN05718P.

This product contains Mefenamic Acid 500mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by SUNWARD PHARMACEUTICAL PTE LTD in SINGAPORE.

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
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Description

A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase. [PubChem]

Indication

For the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain, inflammation, and fever.

Mechanism of Action

Mefenamic acid binds the prostaglandin synthetase receptors COX-1 and COX-2, inhibiting the action of prostaglandin synthetase. As these receptors have a role as a major mediator of inflammation and/or a role for prostanoid signaling in activity-dependent plasticity, the symptoms of pain are temporarily reduced.

Pharmacokinetics

Absorption
Mefenamic acid is rapidly absorbed after oral administration.
Distribution
* 1.06 L/kg [Normal Healthy Adults (18-45 yr)]
Metabolism
Mefenamic acid undergoes metabolism by CYP2C9 to 3-hydroxymethyl mefenamic acid, and further oxidation to a 3-carboxymefenamic acid may occur. The activity of these metabolites has not been studied. Mefenamic acid is also glucuronidated directly.
Elimination

Clearance

* Oral cl=21.23 L/hr [Healthy adults (18-45 yrs)]

Toxicity

Oral, rat LD50: 740 mg/kg. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, dark stool, ringing in the ears, change in amount of urine, unusually fast or slow heartbeat, muscle weakness, slow or shallow breathing, confusion, severe headache or loss of consciousness.

Active Ingredient/Synonyms

Acide méfénamique | Acido mefenamico | Acidum mefenamicum | CN 35355 | INF 3355 | Mefenaminsaeure | Mefenaminsäure | N-(2,3-Xylyl)-2-aminobenzoic acid | N-2,3-Xylylanthranilic acid | Mefenamic acid |


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.

References

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

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