CELECOXIB capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)

Available from:

RedPharm Drug, Inc.

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Celecoxib capsules are indicated 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]. 1.5 Acute Pain (AP) For the management of acute pain in adults [see Clinical Studies (14.5)]. 1.6 Primary Dysmenorrhea (PD) For the management of primary dysmenorrhea [see Clinical Studies (14.5)]. Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings and Precautions (5.7, 5.9) ]. History of asthma, urticaria, or other allergic-type reactions

Product summary:

Celecoxib Capsules are available in the following strengths and configurations: Product Name Description Size NDC number Celecoxib Capsules 50 mg White to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘423’ over ‘50 mg’ on body in red ink. Bottle of 30 capsules Bottle of 60 capsules 69097-423-02 69097-423-03 Celecoxib Capsules 100 mg White to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘422’ over ‘100 mg’ on body in blue ink. Bottle of 30 capsules Bottle of 100 capsules Bottle of 500 capsules 10’s Blister Carton of 100 (10 x 10) Unit- dose Capsules 69097-422-02 69097-422-07 69097-422-12 69097-422-19 69097-422-21 Celecoxib Capsules 200 mg White to off white colored granules filled in size 1 hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘421’ over ‘200 mg’ on body in gold ink. Bottle of 30 capsules Bottle of 100 capsules Bottle of 500 capsules 10’s Blister Carton of 100 (10 x 10) Unit- dose Capsules 69097-421-02 69097-421-07 69097-421-12 69097-421-19 69097-421-21 Celecoxib Capsules 400 mg White to off white colored granules filled in size 0el hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘420’ over ‘400 mg’ on body in green ink. Bottle of 30 capsules Bottle of 60 capsules Bottle of 480 capsules 10’s Blister Carton of 100 (10 x 10) Unit- dose Capsules 69097-420-02 69097-420-03 69097-420-11 69097-420-19 69097-420-21 Storage: Store at 25°C (77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CELECOXIB- celecoxib capsule
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID can cause serious side effects, including:
Increased risk of a heart attack or stroke that can lead to death .
This risk may happen early in treatment and
may increase:
with increasing doses of NSAIDs
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
"coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may have
an increased risk of another heart attack if you take NSAIDs after a
recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth to
the stomach), stomach and intestines :
anytime during use
without warming symptoms
that may cause death
The risk of getting an ulcer or bleeding increases with:
○ past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
○ taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs” or “SNRIs”
○ increasing doses of NSAIDs
○ longer use of NSAIDs
○ smoking
○ drinking alcohol
○ older age
○ poor health
○ advanced liver diseases
○ bleeding problems
NSAID medicines should only be used:
exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed
What are NSAIDs?
NSAID are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions such as
different types of arthritis, menstrual cramps, and other types of
short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory
drugs
(NSAIDs) cause an increased ...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction, and
stroke,
which can be fatal. This risk may occur early in the treatment and may
increase
with duration of use. [see Warnings and Precautions (5.1)]
Celecoxib is contraindicated in the setting of coronary artery bypass
graft (CABG)
surgery. [see Contraindications (4) and Warnings and Precautions (5.1)
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI)
adverse events
including bleeding, ulceration, and perforation of the stomach or
intestines, which
can be fatal. These events can occur at any time during use and
without warning
symptoms. Elderly patients and patients with a prior history of peptic
ulcer disease
and/or GI bleeding are at greater risk for serious GI events. [see
Warnings and
Precautions (5.2) ]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CELECOXIB CAPSULES
safely and effectively. See full prescribing information for CELECOXIB
CAPSULES.
CELECOXIB capsules, for oral use
Initial U.S. Approval:1998
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can
be fatal. This risk may occur early in the treatment and may increase
with duration of
use.(5.1)
Celecoxib is contraindicated in the setting of coronary artery bypass
graft (CABG)
surgery. (4, 5.1)
NSAIDs c