CELECOXIB capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Mylan Pharmaceuticals Inc.

INN (الاسم الدولي):

CELECOXIB

تركيب:

CELECOXIB 50 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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: Use of NSAIDs, including celecoxib capsules, 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 capsules use between about 20 and 30 weeks of gestation and avoid celecoxib capsules use at about 30 weeks of gestation and later in pregnancy [see Cli

ملخص المنتج:

Celecoxib Capsules are available containing 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, USP. The 50 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and a light orange opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7165 in black ink on both the cap and the body. They are available as follows: NDC 0378-7165-91 bottles of 60 capsules The 100 mg capsules are hard-shell gelatin capsules with a lavender opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7160 in black ink on both the cap and the body. They are available as follows: NDC 0378-7160-01 bottles of 100 capsules NDC 0378-7160-05 bottles of 500 capsules The 200 mg capsules are hard-shell gelatin capsules with a light blue opaque cap and a light blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7150 in black ink on both the cap and the body. They are available as follows: NDC 0378-7150-01 bottles of 100 capsules NDC 0378-7150-05 bottles of 500 capsules The 400 mg capsules are hard-shell gelatin capsules with a blue green opaque cap and a blue green opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 7170 in black ink on both the cap and the body. They are available as follows: NDC 0378-7170-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Mylan 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:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
•
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “antiplatelet
drugs”, “anticoagulants”, “SSRIs” or
“SNRIs”
o
increasing doses of NSAIDs
o
older age
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
poor health
o
advanced liver disease
o
bleeding problems
•
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 healthcare provider about all of your
medical

خصائص المنتج

CELECOXIB- CELECOXIB CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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 (5.10) 04/2021
Warnings and Precautions (5.11) 04/2021
INDICATIONS AND USAGE
Celecoxib capsules are 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)
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 CAPSULES ARE 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 years a