CELECOXIB capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DirectRX

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] 1.1 Osteoarthritis (OA) Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis (JRA) Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis (AS) Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain (AP) Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea (PD) Celecoxib is indicated for the treatment of PD [see Clinical S

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DirectRX
----------
SPL MEDGUIDE SECTION
•
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary
artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other
NSAID medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with
each other and cause serious side effects. Keep a list of your
medicines to show to your
healthcare provider and pharmacist.
•
if you are pregnant. NSAID medicines s

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
DIRECTRX
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CELECOXIB
BOXED WARNING SECTION
Cardiovascular Risk Celecoxib may cause an increased risk of serious
cardiovascular
thrombotic events, myocardial infarction, and stroke, which can be
fatal. All nonsteroidal ...
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
Cardiovascular Risk
Celecoxib may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. All
nonsteroidal anti-inflammatory
drugs (NSAIDs) may have a similar risk. This risk may increase with
duration of use.
Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at
greater risk. (5.1,14.6)
Celecoxib is contraindicated for the treatment of peri-operative pain
in the setting of
coronary artery bypass graft (CABG) surgery. (4, 5.1)
Gastrointestinal Risk
NSAIDs, including celecoxib, cause an increased risk of serious
gastrointestinal 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 are at greater risk for serious gastrointestinal
events. (5.4)
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of celecoxib and
other treatment options before
deciding to use celecoxib. Use the lowest effective dose for the
shortest duration consistent with
individual patient treatment goals [see Warnings and Precautions (5)]
1.1 Osteoarthritis (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [see
Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [see
Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in
patients 2 years and older [see
Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [see
Clinical Studies