CELEBREX capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct Rx

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 CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] 1.1 Osteoarthritis (OA) CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis (JRA) CELEBREX 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) CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain (AP) CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea (PD) CELEB

Product summary:

CELEBREX 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as: NDC Number                 Size 0025-1515-01                 bottle of 60 CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as: NDC Number                 Size 0025-1520-31                 bottle of 100 0025-1520-51                 bottle of 500 0025-1520-34                 carton of 100 unit dose CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as: NDC Number                 Size 0025-1525-31                 bottle of 100 0025-1525-51                 bottle of 500 0025-1525-34                 carton of 100 unit dose CELEBREX 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as: NDC Number                 Size 0025-1530-02                 bottle of 60 0025-1530-01              �  carton of 100 unit dose Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Authorization status:

New Drug Application

Patient Information leaflet

Direct Rx
----------
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 shou

Summary of Product characteristics

CELEBREX- CELEBREX CAPSULE
DIRECT RX
----------
CELEBREX
BOXED WARNING SECTION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKSCardiovascular Risk
CELEBREX 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)
CELEBREX 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 CELEBREX, 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 CELEBREX and
other treatment options before
deciding to use CELEBREX. Use the lowest effective dose for the
shortest duration consistent with
individual patient treatment goals [see Warnings and Precautions (5)]
1.1 Osteoarthritis (OA)
CELEBREX is indicated for relief of the signs and symptoms of OA [see
Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
CELEBREX is indicated for relief of the signs and symptoms of RA [see
Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
CELEBREX 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)
CELEBREX is indicated for the relief of signs and symptoms of AS [see
Clinical Studies (14.4)]
1.5 Acute Pain (AP)
CELEBREX is indicated for the management of AP in adults [see Clinical
Studies (14.5)]
1.6 Primary Dysmenorrhea (PD)
CELEBREX is indicated for the treatment of