国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
Vitruvias Therapeutics
ORAL
PRESCRIPTION DRUG
Celecoxib is 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: Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward . Risk Summary Use of NSAIDs, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. A
Celecoxib capsules 200 mg are Size 2# hard gelatin capsules with an opaque-white body and rich-yellow-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting "S14" on the cap and "200" on the body with black ink, supplied as: NDC Number Size 69680-135-00 bottle of 100 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
Vitruvias Therapeutics ---------- 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 taking NSAIDS, tell your healthcare provider about all of your 阅读完整的文件
CELECOXIB- CELECOXIB CAPSULE VITRUVIAS THERAPEUTICS ---------- 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._ • • • RECENT MAJOR CHANGES Warnings and Precautions ( 5.1, 5.4) 6/2018 Warnings and Precautions ( 5.2) 5/2019 INDICATIONS AND USAGE Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: • • • • • • DOSAGE AND ADMINISTRATION • • • • • • Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.7, 8.6, 12.3) Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, ( 2.7, 8.8, 12.3). DOSAGE FORMS AND STRENGTHS Celecoxib capsules: 200 mg ( 3) CONTRAINDICATIONS 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) Osteoarthritis (OA) ( 1.1) Rheumatoid Arthritis (RA) ( 1.2) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) Ankyl 阅读完整的文件