CELECOXIB 200 MG- celecoxib capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Aidarex Pharmaceuticals LLC

DCI (Dénomination commune internationale):

CELECOXIB

Composition:

CELECOXIB 200 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] Celecoxib is inCelecoxib 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 who have demonstrated allergic

Descriptif du produit:

Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder Storage: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
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 you are pregnant. NSAID medic

Résumé des caractéristiques du produit

CELECOXIB 200 MG- CELECOXIB CAPSULE
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CELECOXIB 200 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELECOXIB SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CELECOXIB.
CELECOXIB CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIO VASC ULARRISK
CELECOXIB 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: (1)
• Osteoarthritis (OA) (1.1)R
• heumatoid 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) (1)
DOSAGE AND ADMINISTRATION
USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT.
(1, 5.1, 5.4) (2)
• 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 to 25 kg. 100 mg twice daily
in patients more than 25 kg (2.3, 14.3)
• AS: 20