EXINEF Film-coated tablet Ref.[115929] Active ingredients: Etoricoxib

Source: Health Sciences Authority (SG)  Revision Year: 2025  Publisher: Organon Singapore Pte. Ltd., 16 Raffles Quay, #18-01 Hong Leong Building, Singapore 048581

Product name and form

EXINEF 60 mg Tablets.

EXINEF 90 mg Tablets.

EXINEF 120 mg Tablets.

Pharmaceutical Form

Film-coated tablet.

60 mg Tablets: Dark green, apple-shaped, biconvex tablets debossed '200' on one side and plain on the other side.

90 mg Tablets: White, apple-shaped, biconvex tablets debossed '202' on one side and plain on the other side.

120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed '204' on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 60, 90 or 120 mg of etoricoxib.

For excipients, see 6.1.

Active Ingredient

Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.

List of Excipients

Core:

Calcium hydrogen phosphate (anhydrous)
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose

Tablet coating:

Carnauba wax
Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Glycerol triacetate

The 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).

Pack sizes and marketing

EXINEF Tablets 60 mg, 90 mg and 120 mg are available in cartons of 100's.

Marketing authorization holder

Organon Singapore Pte. Ltd., 16 Raffles Quay, #18-01 Hong Leong Building, Singapore 048581

Drugs

Drug Countries
EXINEF Italy, Singapore, South Africa

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