CELECOXIB- celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Celecoxib is contraindicated in the following patients : Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including celecoxib, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of celecoxib in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2–4% for major malformations, and 15–20% for pregnancy loss. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately

Product summary:

Celecoxib 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: Bottle of 30 - 68788-9993-3 Bottle of 60 - 68788-9993-6 Bottle of 90 - 68788-9993-9 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Preferred Pharmaceuticals, Inc.
----------
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:
1.
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
1.
with increasing doses of NSAIDs
2.
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.
1.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
1.
anytime during use
2.
without warning symptoms
3.
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", "anticoagulants", "SSRIs"
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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:
1.
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
2.
right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your
medical conditions, including

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELECOXIB SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CELECOXIB.
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._
1.
2.
3.
RECENT MAJOR CHANGES
Boxed Warning
6/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
6/2016
Warnings and Precautions, Heart Failure and Edema (5.5)
6/2016
INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
1.
2.
3.
4.
5.
6.
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals (2.1)
1.
2.
3.
4.
5.
Hepatic Impairment: Reduce daily dose by 50% in patients with moderate
hepatic impairment (Child-Pugh Class B). (2.7,
8.6, 12.3)
Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by
50% (or alternative management for JRA) in
patients who are known or suspected to be CYP2C9 poor metabolizers,
(2.7, 8.8, 12.3).
DOSAGE FORMS AND STRENGTHS
Celecoxib capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)
CONTRAINDICATIONS
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 GRE