Celcoxx 100mg Capsule

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

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Active ingredient:

Celecoxib

Available from:

GETZ PHARMA (PHILS.) INC.; Distributor: GETZ PHARMA (PHILS.) INC.

INN (International Name):

Celecoxib

Dosage:

100mg

Pharmaceutical form:

Capsule

Units in package:

Alu-Alu Blister Pack x 10's (Box of 20’s), Alu/Alu Blister pack x 10's (box of 20's)

Manufactured by:

Getz Pharma Pvt. Ltd., Pakistan

Authorization date:

2021-12-06

Summary of Product characteristics

                                WARNINGS
PRECAUTIONS
_General:_
Celecoxib cannot be expected to substitute for corticosteroids or to
treat corticosteroid insufficiency.
Abrupt discontinuation of corticosteroids may lead to exacerbation of
corticosteroid-responsive
illness. Patients on prolonged corticosteroid therapy should have
their therapy tapered slowly
if a decision is made to discontinue corticosteroids.
_Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and
Perforation:_
Serious gastrointestinal toxicity such as bleeding, ulceration, and
perforation of the stomach,
small intestine or large intestine, can occur at any time, with or
without warning symptoms, in
patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs).
Minor upper gastrointestinal
problems, such as dyspepsia, are common and may also occur at any time
during NSAID
therapy. With longer duration of use of NSAIDs, there is a trend for
increasing the likelihood
of developing a serious GI event at some time during the course of the
rapy. However, even
short-term therapy is not without risk. Therefore, physicians and
patients should remain alert
for ulceration and bleeding, even in the absence of previous GI tract
symptoms.
NSAIDs should be prescribed with extreme caution in patients with a
prior history of ulcer
disease or gastrointestinal bleeding. To minimize the potential risk
for an adverse GI event, the
lowest effective dose should be used for the shortest possible
duration.
_Congestive Heart Failure and Edema:_
Fluid retention and edema have been observed in some patients taking
celecoxib. Therefore,
celecoxib should be used with caution in patients with fluid
retention, hypertension, or heart
failure.
_Hypertension:_
As with all NSAIDs, celecoxib can lead to the onset of new
hypertension or worsening of p
re-
existing hypertension, either of which may contribute to the increased
incidence of cardiovascular
events. Patients taking thiazides or loop diuretics may have impaired
response to these therapies
when taking NSAIDs. NSAIDs, including celecox
                                
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