Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
KOTRA PHARMA (M) SDN. BHD.
ETORICOXIB
30tablet Tablets; 100 Tablets
KOTRA PHARMA (M) SDN. BHD.
AXCEL ETORICOXIB -120MG TABLET _Etoricoxib 120mg _ _ _ _ _ _ _ 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What Axcel Etoricoxib-120mg Tablet is used for. 2. How Axcel Etoricoxib-120mg Tablet works. 3. Before you use Axcel Etoricoxib-120mg Tablet. 4. How to use Axcel Etoricoxib- 120mg Tablet. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Etoricoxib-120mg Tablet. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL ETORICOXIB- 120MG TABLET IS USED FOR It helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with gout. It is also use for the treatment of acute pain, including that of primary dysmenorrhea (menstrual cramp). WHAT IS GOUT? Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint. HOW AXCEL ETORICOXIB- 120MG TABLET WORKS Etoricoxib is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), that exhibits anti-inflammatory, analgesic, and antipyretic activities. BEFORE YOU USE AXCEL ETORICOXIB-120MG TABLET WHEN YOU MUST NOT USE IT You must not use Axcel Etoricoxib- 120mg Tablet if you: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of Axcel Etoricoxib- 120mg Tablet • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors • if you have a current stomach ulcer or bleeding in your stomach or intestines • if you have serious liver disease • if you have serious kidney disease • if you are or could be pregnant or are breast-feeding • if you are under 16 years of age • if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis • if your doctor has diagnosed heart problems including heart failure (moderate or sev Read the complete document
AXCEL ETORICOXIB - 90MG TABLET COMPOSITION: Each tablet contains: Etoricoxib 90mg PRESENTATION: White coloured, round shape with 8.0mm diameter, biconvex, embossed with ‘Kotra’ logo on one side and breakline on the other side. AXCEL ETORICOXIB - 120MG TABLET COMPOSITION: Each tablet contains Etoricoxib 120mg PRESENTATION: Green coloured, round shape with 9.8mm diameter, biconvex, embossed with ‘Kotra’ logo on one side and breakline on the other side. INDICATIONS: For acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA). Treatment of ankylosing spondylitis (AS), acute gouty arthritis, and acute pain, including that related to primary dysmenorrhoea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks. PHARMACOLOGY: _Mechanism of Action:_ Etoricoxib is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. Etoricoxib is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor within and above the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and platelet inhibition. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib decreases these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function. _Pharmacokinetics:_ _Absorption:_ In studies specifically designated to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing. Orally administered etoricoxib is well a Read the complete document