CELECOXIB- celecoxib capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

CELECOXIB

Composition:

CELECOXIB 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 : - 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 aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [ see Warnings and Precautions

Descriptif du produit:

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 30 NDC 68071-2169-3 Storage : Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CELECOXIB- CELECOXIB CAPSULE
NUCARE 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._
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)
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
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 dosage for the shortest duration consistent with
individual patient treatment goals ( 2.1)
OA: 200 mg once daily or 100 mg twice daily ( 2.2, 14.1)
RA: 100 to 200 mg twice daily ( 2.3, 14.2)
JRA: 50 mg twice daily in patients 10 to 25 kg. 100 mg twice daily in
patients more than