CELEBREX- celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Celecoxib (UNII: JCX84Q7J1L) (Celecoxib - UNII:JCX84Q7J1L)

Available from:

Cardinal Health

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) ] CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1) ] CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2) ] CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ] CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4) ] CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5) ] CELEBREX is indicated for the treatment of PD [see Clinical Studies (14.5) ] CELEBREX is contraindicated: Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Teratogenic effects : Celecoxib at oral doses ≥150 mg/kg/day (approx

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

Cardinal Health
----------
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
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 should not be used by pregnant
women late in their
pregn

Summary of Product characteristics

CELEBREX- CELECOXIB CAPSULE
CARDINAL HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELEBREX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CELEBREX.
CELEBREX (CELECOXIB) CAPSULES
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
INDICATIONS AND USAGE
CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT.
(1, 5.1, 5.4)
•
•
•
•
•
Reduce daily dose by 50% in patients with moderate hepatic impairment
(Child-Pugh Class B).
Consider a dose reduction by 50% (or alternative management for JRA)
in patients who are known or suspected to be
CYP2C9 poor metabolizers, (2.6, 8.4, 8.8, 12.3).
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)
CONTRAINDICATIONS
®
CELEBREX MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR
THROMBOTIC EVENTS, MYOCARDIAL
INFARCTION, AND STROKE, WHICH CAN BE FATAL. ALL 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)_
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 (GI) EVENTS. _(5.4)_
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and