CELECOXIB capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Direct_Rx

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Celecoxib capsules are indicated 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis(JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies (14.5)] Celecoxib capsules are 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 aspir

leaflet_short:

Celecoxib capsules 50 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C50” is imprinted on each capsule in red ink. They are supplied as follows: Bottles of 30s Bottles of 60s Bottles of 100s Bottles of 1,000 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: Bottles of 30s Bottles of 100s Bottles of 500s Bottles of 1,000 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: Bottles of 30s Bottles of 100s Bottles of 500s Bottles of 1,000 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].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

CELECOXIB- CELECOXIB CAPSULE
Direct_Rx
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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
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 healthcare provider about all of your
medical conditions, including if
you:
have liver or kidney problems
have hi

מאפייני מוצר

CELECOXIB- CELECOXIB CAPSULE
DIRECT_RX
----------
CELECOXIB 200MG
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs
(NSAIDs) cause an
increased risk of serious cardiovascular thrombotic events, including
...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
Cardiovascular Thrombotic Events
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 [see Warnings
and Precautions (5.1) ].
Celecoxib is contraindicated in the setting of coronary artery bypass
graft (CABG) surgery [see
Contraindications (4) and Warnings and Precautions (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
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. [see Warnings and Precautions (5.2)]
Celecoxib capsules are indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical
Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical
Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis(JRA)
For the management of the signs and symptoms of JRA in patients 2
years and older [see Clinical Studies
(14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see Clinical
Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies
(14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies
(14.5)]
2.1 General Dosing Instructions
Carefully consider the potential benefits and risks