ARCOXIA Film-coated tablet

Active ingredients: Etoricoxib

Product name and form

ARCOXIA 30 mg film-coated tablets.
ARCOXIA 60 mg film-coated tablets.
ARCOXIA 90 mg film-coated tablets.
ARCOXIA 120 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets (tablets).

30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed ‘101’ on one side and ‘ACX 30’ on the other side.

60 mg tablets: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and ‘ARCOXIA 60’ on the other side.

90 mg tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side.

120 mg tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and ‘ARCOXIA 120’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.

Excipients with known effect:

30 mg tablet: 1.3 mg lactose (as monohydrate).

60 mg tablet: 2.7 mg lactose (as monohydrate).

90 mg tablet: 4.0 mg lactose (as monohydrate).

120 mg tablet: 5.3 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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)
Triacetin

The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).

Pack sizes and marketing

30 mg: Aluminium/aluminium blisters in packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets.

60 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.

90 and 120 mg: Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.

60, 90 and 120 mg: Aluminium/aluminium blisters (unit doses) in packs of 5, 50 or 100 tablets.

White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two 1-gram desiccant containers or 90 tablets and one 1-gram desiccant container.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

30 mg Tablets: PL 04900/0001
60 mg Tablets: PL 04900/0002
90 mg Tablets: PL 04900/0003
120 mg Tablets: PL 04900/0004

Date of latest renewal:

30 mg Tablets: 22/10/2007
60 mg Tablets: 13/02/2002
90 mg Tablets: 13/02/2002
120 mg Tablets: 13/02/2002

Drugs

Drug
Countries
Austria, Brazil, Cyprus, Germany, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom