Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
ECOXAR 30 mg Film coated tablets.
ECOXAR 60 mg Film coated tablets.
ECOXAR 90 mg Film coated tablets.
ECOXAR 120 mg Film coated tablets.
| Pharmaceutical Form |
|---|
|
ECOXAR 30 mg: Blue green, film coated, round biconvex tablets, E30 debossed on one side and plain on other side. ECOXAR 60 mg: Green to dark green, film coated, round biconvex tablets, E60 debossed on one side and plain on other side. ECOXAR 90 mg: White to off white, film coated, round biconvex tablets, E90 debossed on one side and plain on other side. ECOXAR 120 mg: Light green to pale green, film coated round biconvex tablets, E120 debossed on one side and plain on other side. |
ECOXAR 30 mg: Each film coated tablet contains etoricoxib 30 mg.
Contains sugar: lactose monohydrate 1,05 mg/coated tablet.
ECOXAR 60 mg: Each film coated tablet contains etoricoxib 60 mg.
Contains sugar: lactose monohydrate 2,10 mg/coated tablet.
ECOXAR 90 mg: Each film coated tablet contains etoricoxib 90 mg.
Contains sugar: lactose monohydrate 3,15 mg/coated tablet.
ECOXAR 120 mg: Each film coated tablet contains etoricoxib 120 mg.
Contains sugar: lactose monohydrate 4,20 mg/coated tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etoricoxib |
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 |
|---|
|
Cellulose microcrystalline Coating: 30 mg: Opadry II green 32K510020 (lactose monohydrate, hypromellose, titanium dioxide, triacetin, indigo carmine aluminium lake, iron oxide yellow) 60 mg: Opadry II green 35K510000 (lactose monohydrate, hypromellose, titanium dioxide, triacetin, indigo carmine aluminium lake, iron oxide yellow) 90 mg: Opadry II white 35K580003 (lactose monohydrate, hypromellose, titanium dioxide, triacetin) 120 mg: Opadry II green 32K510018 (lactose monohydrate, hypromellose, titanium dioxide, triacetin, indigo carmine aluminium lake, iron oxide yellow) |
The tablets are packed in cold form blisters. Each blister strip contains 7 tablets. Carton contains 7 or 28 tablets.
Cold form blister pack: Cold form blister pack comprises of cold form blister laminate composed of oriented polyamide, aluminium foil and PVC film with backing of hard tempered aluminium foil coated with heat seal lacquer on the inner side.
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
ECOXAR 30 mg: 51/3.1/1144
ECOXAR 60 mg: 51/3.1/1145
ECOXAR 90 mg: 51/3.1/1146
ECOXAR 120 mg: 51/3.1/1147
Date of registration: February 2020
| Drug | Countries | |
|---|---|---|
| ECOXAR | South Africa |
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