CELECOXIB capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Medstone Pharma LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Celecoxib is indicated for: 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 Precautions (5.7, 5.8)] . - In the

Tuoteyhteenveto:

Celecoxib 50 mg capsules are white, with “OE” imprinted on the cap and “50” on the body, supplied as: NDC 71626-301-60             bottle of 60 with child-resistant closure Celecoxib 100 mg capsules are white, with “OE” imprinted on the cap and “100” on the body, supplied as: NDC 71626-302-30             bottle of 30 with child-resistant closure NDC 71626-302-01             bottle of 100 with child-resistant closure Celecoxib 200 mg capsules are white, with “OE” imprinted on the cap and “200” on the body, supplied as: NDC 71626-303-30             bottle of 30 with child-resistant closure NDC 71626-303-01             bottle of 100 with child-resistant closure NDC 71626-303-05             bottle of 500 with child-resistant closure Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child resistant containers.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

CELECOXIB- CELECOXIB CAPSULE
Medstone Pharma LLC
----------
MEDICATION GUIDE
For Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
(Celecoxib Capsules)
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”,
“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:
•
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 he

Valmisteyhteenveto

CELECOXIB- CELECOXIB CAPSULE
MEDSTONE PHARMA 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
Warnings and Precautions (5.1, 5.4) 6/2018
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 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 effect
is observed after 6 weeks, a trial of 4