CELEBREX- celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp.

INN (International Name):

Celecoxib

Composition:

Celecoxib 100 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 indicated to reduce the number of adenomatous colorectal polyps in FAP, as an adjunct to usual care (e.g., endoscopic surveillance, surgery). It is not known whethe

Product summary:

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 21695-022-15                 bottle of 15 21695-022-30                 bottle of 30 21695-022-60                 bottle of 60 21695-022-00                 bottle of 100 21695-022-72                 bottle of 120 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 21695-023-14                 bottle of 14 21695-023-15                 bottle of 15 21695-022-30                 bottle of 30 21695-022-60                 bottle of 60 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

Rebel Distributors Corp.
----------
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 should not

Summary of Product characteristics

CELEBREX - CELECOXIB CAPSULE
REBEL DISTRIBUTORS CORP.
----------
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
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. _(5.1,14.7)_
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 (GI) EVENTS. _(5.4)_
INDICATIONS AND USAGE
CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older
(1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
Familial Adenomatous Polyposis (FAP)-adjunct to usual care) (1.7)
DOSAGE AND ADMINISTRATION
USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT.
(1, 5.1, 5.4)
OA: 200 mg once daily or 100 mg twice daily (2.1, 14.1)
RA: 100 to 200 mg twice daily (2.2, 14.2)
JRA: 50 mg twice daily in patients 10–25 kg. 100 mg twice daily in
patients more than 25 kg (2.3, 14.3)
AS: 200 mg once daily si