国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
American Health Packaging
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 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) ]. - 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 Precauti
Celecoxib capsules are available as follows: 100 mg – hard gelatin capsules with an opaque-white body and blue-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7165” on the body, in unit dose packages of 100 (10 x 10) NDC 68084-969-01. 200 mg – hard gelatin capsules with an opaque-white body and yellow-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7166” on the body, in unit dose packages of 100 (10 x 10) NDC 68084-976-01. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
American Health Packaging ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS) 8296901/1216OS 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”, “anticoagulants”, “SSRIs” or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • 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 taking NSAIDs, tell your healthcare provider about al 完全なドキュメントを読む
CELECOXIB- CELECOXIB CAPSULE AMERICAN HEALTH PACKAGING ---------- 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 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 capsules are 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 pa 完全なドキュメントを読む