Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
NuCare Pharmaceuticals, Inc.
CELECOXIB
CELECOXIB 100 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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 Lue koko asiakirja