CELECOXIB capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

RedPharm Drug, Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Celecoxib is 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 For the management of acute pain in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies (14.5)] Celecoxib is 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 after tak

Bidhaa muhtasari:

Celecoxib capsules 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder. NDC 62332-140-30 bottle of 30 capsules NDC 62332-140-60 bottle of 60 capsules NDC 62332-140-91 bottle of 1000 capsules NDC 62332-140-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-140-10 carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder. NDC 62332-141-30 bottle of 30 capsules NDC 62332-141-31 bottle of 100 capsules NDC 62332-141-91 bottle of 1000 capsules NDC 62332-141-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-141-10 carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder. NDC 62332-142-30 bottle of 30 capsules NDC 62332-142-31 bottle of 100 capsules NDC 62332-142-71 bottle of 500 capsules NDC 62332-142-91 bottle of 1000 capsules NDC 62332-142-08 carton of 80 (10 x 8) unit-dose capsules NDC 62332-142-10 carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder. NDC 62332-143-30 bottle of 30 capsules NDC 62332-143-60 bottle of 60 capsules NDC 62332-143-71 bottle of 500 capsules NDC 62332-143-10 carton of 100 (10 x 10) unit-dose capsules NDC 62332-143-14 carton of 126 (9 x 14) unit-dose capsules Storage: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

CELECOXIB- celecoxib capsule
RedPharm Drug, Inc.
----------
MEDICATION GUIDE FOR
NONSTEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs 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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o Without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs” or “SNRIs”
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs 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 conditions,

Tabia za bidhaa

CELECOXIB- CELECOXIB CAPSULE
REDPHARM DRUG, INC.
----------
CELECOXIB
BOXED WARNING
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 CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE
EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMA