CELECOXIB capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Major Pharmaceuticals

INN (International namn):

CELECOXIB

Sammansättning:

CELECOXIB 100 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of cele

Produktsammanfattning:

Celecoxib capsules 100 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C100” is imprinted on each capsule in blue ink. They are supplied as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-6502-61 Celecoxib capsules 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C200” is imprinted on each capsule in yellow ink. They are supplied as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-6503-61 Storage: Store at 20°C to 25°C (68°F  to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].                                               

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

CELECOXIB- CELECOXIB CAPSULE
Major Pharmaceuticals
----------
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:
1.
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
2.
taking medicines called "corticosteroids", “antiplatelet drugs”,
"anticoagulants", "SSRIs" or "SNRIs"
3.
increasing doses of NSAIDs
4.
longer use of NSAIDs
5.
smoking
6.
drinking alcohol
7.
older age
8.
poor health
9.
advanced liver disease
10.
bleeding problems
NSAIDs should only be used:
1.
exactly as prescribed
2.
at the lowest dose possible for your treatment
3.
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 y

Produktens egenskaper

CELECOXIB- CELECOXIB CAPSULE
MAJOR PHARMACEUTICALS
----------
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._
4.
5.
6.
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
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
(2.1)
6.
7.
8.
9.
10.
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
Capsules: 50 mg, 100 mg and 200 mg (3)
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)