CELECOXIB- celecoxib capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Preferred Pharmaceuticals Inc.

INN（国际名称）:

CELECOXIB

组成:

CELECOXIB 200 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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: 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 celec

產品總結:

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 30                            NDC 68788-6463-3 Bottles of 60                            NDC 68788-6463-6 Bottles of 90                            NDC 68788-6463-9 Bottles of 100                          NDC 68788-6463-1 Bottles of 120                          NDC 68788-6463-8 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

资料单张

CELECOXIB- CELECOXIB CAPSULE
Preferred Pharmaceuticals Inc.
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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

产品特点

CELECOXIB- CELECOXIB CAPSULE
PREFERRED PHARMACEUTICALS INC.
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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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.4) 6/2018
Warnings and Precautions (5.2) 5/2019
INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
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 GREATER RISK
FOR SERIOUS GI EVENTS. (5.2)
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2