Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
REMEDYREPACK INC.
CELECOXIB
CELECOXIB 200 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CELECOXIB- CELECOXIB CAPSULE REMEDYREPACK 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 the lowest effective dosage for 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 25 kg ( 2.4 Прочитајте комплетан документ