CELECOXIB capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Greenstone LLC

INN (الاسم الدولي):

CELECOXIB

تركيب:

CELECOXIB 50 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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: Risk Summary Use of NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib use between about 20 and 30 weeks of gestation and avoid celecoxib use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data )

ملخص المنتج:

Celecoxib 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as: 59762-1515-1 bottle of 60 Celecoxib 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: 59762-1516-1 bottle of 100 59762-1516-3 bottle of 500 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: 59762-1517-1 bottle of 100 59762-1517-3 bottle of 500 Celecoxib 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as: 59762-1518-2 bottle of 60 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].

الوضع إذن:

New Drug Application Authorized Generic

نشرة المعلومات

XIB- CELECOXIB CAPSULE
Greenstone 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:
•
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
•
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?
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (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 byp

خصائص المنتج

CELECOXIB- CELECOXIB CAPSULE
GREENSTONE LLC
----------
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.
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 effect
is observed after 6 week