CELECOXIB capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Celecoxib capsules are  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 capsules are 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 Warnin

Product summary:

Celecoxib Capsules, 50 mg are white cap/white body, size ‘5’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘50’ on the body with red ink.         Bottles of 60                                NDC 65862-907-60         Bottles of 1,000                           NDC 65862-907-99 Celecoxib Capsules, 100 mg are white cap/white body, size ‘4’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘100’ on the body with blue ink.         Bottles of 100                              NDC 65862-908-01         Bottles of 500                              NDC 65862-908-05         Bottles of 1,000                           NDC 65862-908-99 Celecoxib Capsules, 200 mg are white cap/white body, size ‘2’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘200’ on the body with gold ink.         Bottles of 100                              NDC 65862-909-01         Bottles of 500                              NDC 65862-909-05         Bottles of 1,000                           NDC 65862-909-99 Celecoxib Capsules, 400 mg are white cap/white body, size ‘0’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘400’ on the body with green ink.         Bottles of 60                                NDC 65862-910-60         Bottles of 100                              NDC 65862-910-01         Bottles of 500                              NDC 65862-910-05 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CELECOXIB - celecoxib capsule
Aurobindo Pharma Limited
----------
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:
•
with increasing doses of NSAIDs
•
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:
•
anytime during use
•
without warning symptoms
•
that may cause death
•
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “antiplatelet
drugs”, “anticoagulants”, “SSRIs” or
“SNRIs”
•
increasing doses of NSAIDs
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
•
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
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

Summary of Product characteristics

CELECOXIB - CELECOXIB CAPSULE
AUROBINDO PHARMA LIMITED
----------
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
Warnings and Precautions (5.10) 04/2021
Warnings and Precautions (5.11) 04/2021
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)
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 mg to 200 mg twice daily. (2.3, 14.2)
JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily
in patients more than 25 kg. (2.4,
14.3)
AS: 200 mg once daily single dose or 100 mg twice daily. If no