ประเทศ: มาเลเซีย
ภาษา: อังกฤษ
แหล่งที่มา: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
ALLPAC SOLUTIONS SDN. BHD.
CELECOXIB
1x10 Capsules; 10x10 Capsules; 3x10 Capsules
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ALLPAC CELECOXIB CAPSULE 200 MG Celecoxib (200mg) 1 WHAT IS IN THIS LEAFLET 1. What Allpac Celecoxib is used for 2. How Allpac Celecoxib works 3. Before you use Allpac Celecoxib 4. How to use Allpac Celecoxib 5. While you are using Allpac Celecoxib 6. Side effects 7. Storage and Disposal of Allpac Celecoxib 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT ALLPAC CELECOXIB IS USED FOR For the management of acute pain in adults and as primary treatment for pain associated with menstruation (dysmenorrhea). Relief of the acute and chronic pain and inflammation of rheumatoid arthritis and osteoarthritis (pain at joints). Relief of signs and symptoms of inflammation at spine and other areas of the body (ankylosing spondylitis). For relief of low back pain. HOW ALLPAC CELECOXIB WORKS Celecoxib is a nonsteroidal anti- inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. BEFORE YOU USE ALLPAC CELECOXIB _ _ _- When you must not use it _ Do not take this medicine if: • You are allergic to celecoxib or any of the other ingredients of this medicine. • You have an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections). • You currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines. • As a result of taking acetylsalicylic acid or any other anti- inflammatory and pain-relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing. • You are pregnant. If you can become pregnant during ongoing treatment you should discuss methods of contraception with your doctor. • You are breast-feeding • You have severe liver disease • You have severe kidney disease. • You have an inflammatory disease of the in อ่านเอกสารฉบับเต็ม
ALLPAC CELECOXIB CAPSULE 200 MG VICELxx-03 DESCRIPTION White opaque/white opaque capsule with “CL200” printed on one end and “hovid” printed on the other end Fill material: white to off white granules Capsule size: size 0 COMPOSITION Each capsule contains Celecoxib 200 mg. PHARMACODYNAMICS Mechanism of action: Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the range (200-400 mg daily). Pharmacodynamic effects: Cyclooxygenase is responsible for generation of prostagladins. 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 human but its relevance to ulcer healing has not been established. The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane. Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics). A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib. PHARMACOKINETICS Absorption: Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Dosing with food (high fat meal) delays absorption of celecoxib by about 1 hour resulting in อ่านเอกสารฉบับเต็ม