SYNERRV CELECOXIB HARD CAPSULES 200MG

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

CELECOXIB

Disponibil de la:

SYNERRV (S) PTE. LTD.

Codul ATC:

M01AH01

Forma farmaceutică:

CAPSULE

Compoziție:

CELECOXIB 200.00MG

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

UMEDICA LABORATORIES PRIVATE LIMITED

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2021-06-29

Caracteristicilor produsului

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