Երկիր: Սինգապուր
Լեզու: անգլերեն
Աղբյուրը: HSA (Health Sciences Authority)
CELECOXIB
SYNERRV (S) PTE. LTD.
M01AH01
CAPSULE
CELECOXIB 200.00MG
ORAL
Prescription Only
UMEDICA LABORATORIES PRIVATE LIMITED
ACTIVE
2021-06-29
1 SYNERRV CELECOXIB NAME AND STRENGTH OF ACTIVE INGREDIENTS: Each 100 mg capsule contains 100 mg celecoxib Each 200 mg capsule contains 200 mg celecoxib PRODUCT DESCRIPTION: CELECOXIB HARD CAPSULES 100 MG (SYNERRV CELECOXIB): Size ‘3’, white to white opaque hard gelatin capsules, imprinted with ‘CEL’ on cap & ‘100 mg’ on body in black ink, filled with white to off-white slug to granular powder. CELECOXIB HARD CAPSULES 200 MG (SYNERRV CELECOXIB): Size '2', White to White opaque hard gelatin capsules, imprinted with 'CEL' on cap & '200 mg' on body in black ink, filled with white to off-white slug to granular powder. PHARMACODYNAMICS / PHARMACOKINETICS: PHARMACODYNAMICS: PHARMACOTHERAPEUTIC GROUP: M01AH Coxibs The mechanism of action of celecoxib is via inhibition of prostaglandin synthesis primarily by inhibition of cyclo- oxgenase 2 (COX-2). At therapeutic concentrations in humans celecoxib does not inhibit cyclo-oxygenase-1 (COX- 1). COX-2 is induced in response to inflammatory stimuli. This leads to the synthesis and accumulation of inflammatory prostanoids, in particular prostaglandin E2, causing inflammation, oedema and pain. Celecoxib acts as an anti-inflammatory, analgesic, and antipyretic agent in animal models by blocking the production of inflammatory prostanoids via COX-2 inhibition. In vivo and ex vivo studies show that celecoxib has a very low affinity for the constitutively expressed COX-1 enzyme. Consequently at therapeutic doses celecoxib has no effect on prostanoids synthesized by activation of COX-1 thereby not interfering with normal COX-1 related physiological processes in tissues, particularly the stomach, intestine and platelets. CLINICAL STUDIES OSTEOARTHRITIS (OA): Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in approximately 4,200 patients in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment w Կարդացեք ամբողջական փաստաթուղթը