CELECOXIB - celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Celecoxib is indicated For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ] For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ] For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ] For the management of the signs and symptoms of AS [see Clinical Studies (14.4) ] For the management of acute pain in adults [see Clinical Studies (14.5) ] 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 taking aspirin or other   NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been        reported in such patients [see Warnings and Precauti

Product summary:

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 13811-658-30    bottle of 30 capsules NDC 13811-658-60    bottle of 60 capsules NDC 13811-658-01    bottle of 1000 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 13811-659-30    bottle of 30 capsules NDC 13811-659-10    bottle of 100 capsules NDC 13811-659-01    bottle of 1000 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 13811-660-30    bottle of 30 capsules NDC 13811-660-10    bottle of 100 capsules NDC 13811-660-50    bottle of 500 capsules NDC 13811-660-01    bottle of 1000 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 13811-661-30    bottle of 30 capsules    NDC 13811-661-60    bottle of 60 capsules NDC 13811-661-50    bottle of 500 capsules Storage : Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CELECOXIB - CELECOXIB CAPSULE
Trigen Laboratories, LLC
----------
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 cond

Summary of Product characteristics

CELECOXIB - CELECOXIB CAPSULE
TRIGEN LABORATORIES, LLC
----------
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 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. (5.2)
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
INDICATIONS AND USAGE
Celecoxib 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) (1)
DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent
with individual patient treatment goals (2.1)
• OA: 200 mg once daily or 100 mg twice daily (2.2, 14.1)
• RA: 100 to 200 mg twice daily (2.3, 14.2)
• JRA: 50 mg twice daily in patients 10 to 25 kg. 1