CELECOXIB- celecoxib capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Lake Erie Medical DBA Quality Care Products LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)] Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)] Celecoxib is contraindicated: - In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. In patients with known hypersensitivity to

Ապրանքի ամփոփագիր:

Celecoxib 50 mg capsules are opaque light pink cap printed "WPI " with black ink and opaque white colored body printed "50 " with black ink containing white colored granular powder, supplied as: Celecoxib 100 mg capsules are opaque light blue cap printed "WPI " with black ink and opaque white colored body printed "100 " with black ink containing white colored granular powder, supplied as: Celecoxib 200 mg capsules are opaque light yellow cap printed "WPI " with black ink and opaque white colored body printed "200 " with black ink containing white colored granular powder, supplied as: 55700-337-14 55700-337-30 55700-337-60 Celecoxib 400 mg capsules are opaque light green cap printed "WPI " with black ink and opaque white colored body printed "400 " with black ink containing white colored granular powder, supplied as: Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Lake Erie Medical DBA Quality Care Products LLC
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MEDGUIDE
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do
not take an NSAID
medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if yo

Ապրանքի հատկությունները

CELECOXIB- CELECOXIB CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 CAPSULES.
CELECOXIB CAPSULES
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOVASCULAR RISK
CELECOXIB CAPSULES MAY CAUSE AN INCREASED RISK OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS,
MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. ALL NSAIDS MAY
HAVE A SIMILAR RISK. THIS RISK MAY
INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR
RISK FACTORS FOR CARDIOVASCULAR
DISEASE MAY BE AT GREATER RISK. (5.1,14.6)
CELECOXIB IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN
IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY. (4,5.1)
GASTROINTESTINAL RISK
NSAIDS, INCLUDING CELECOXIB, CAUSE AN INCREASED RISK OF SERIOUS
GASTROINTESTINAL 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 ARE AT GREATER
RISK FOR SERIOUS GASTROINTESTINAL (GI) EVENTS. (5.4)
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 LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT.
(1, 5.1, 5.4)
OA: 200 mg once daily or 100 mg twice daily (2.1, 14.1)
RA: 100 to 200 mg twice daily (2.2, 14.2)
JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in
patients more than 25 kg (2.3, 14.3)
AS: 200 mg once daily single dose or 100 mg twice daily. If no e