Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
Jubilant Cadista Pharmaceuticals Inc.
CELECOXIB
CELECOXIB 50 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 is 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)]. 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
Celecoxib capsules 50 mg are white opaque colored cap and body, size '4' hard gelatin capsules, printed in red ink on cap and body with marking C 561 containing off white to white granular powder, supplied as: Bottle of 30’s count (child-resistant closure) NDC 59746-561-30 Bottle of 60’s count (child-resistant closure) NDC 59746-561-60 Bottle of 100’s count (child-resistant closure) NDC 59746-561-01 Bottle of 1000’s count NDC 59746-561-10 Celecoxib capsules 100 mg are white opaque colored cap and body, size '3' hard gelatin capsules, printed in blue ink on cap and body with marking C 562 containing off white to white granular powder, supplied as: Bottle of 30’s count (child-resistant closure) NDC 59746-562-30 Bottle of 100’s count (child-resistant closure) NDC 59746-562-01 Bottle of 500’s count NDC 59746-562-05 Bottle of 1000’s count NDC 59746-562-10 Celecoxib capsules 200 mg are white opaque colored cap and body, size '2' hard gelatin capsules, printed in yellow ink on cap and body with marking C 563 containing off white to white granular powder, supplied as: Bottle of 30’s count (child-resistant closure) NDC 59746-563-30 Bottle of 100’s count (child-resistant closure) NDC 59746-563-01 Bottle of 500’s count NDC 59746-563-05 Bottle of 1000’s count NDC 59746-563-10 Celecoxib capsules 400 mg are white opaque colored cap and body, size '0el' hard gelatin capsules, printed in green ink on cap and body with marking C 564 containing off white to white granular powder, supplied as: Bottle of 30’s count (child-resistant closure) NDC 59746-564-30 Bottle of 60’s count (child-resistant closure) NDC 59746-564-60 Bottle of 100’s count (child-resistant closure) NDC 59746-564-01 Bottle of 400’s count NDC 59746-564-67 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CELECOXIB - CELECOXIB CAPSULE Jubilant Cadista Pharmaceuticals Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: ○ past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs ○ taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs” ○ increasing doses of NSAIDs ○ older age ○ longer use of NSAIDs ○ poor health ○ smoking ○ advanced liver disease ○ drinking alcohol ○ bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before tak read_full_document
CELECOXIB - CELECOXIB CAPSULE JUBILANT CADISTA 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 CAPSULES ARE 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 Warnings and Precautions (5.1, 5.4) 6/2018 Warnings and Precautions (5.2) 5/2019 INDICATIONS AND USAGE Celecoxib capsules are 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 mg to 200 mg twice daily (2.3, 14.2) JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg (2.4, 14.3) AS: 200 mg once daily single dose o read_full_document