Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
Aidarex Pharmaceuticals LLC
CELECOXIB
CELECOXIB 200 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1) ] CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2) ] CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ] CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4) ] CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5) ] CELEBREX is indicated for the treatment of PD [see Clinical Studies (14.5) ] CELEBREX is contraindicated: - In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. - In patients who have demonstrated allergic-type reactions to su
CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as: NDC Number Size 33261-019-10 bottle of 10 33261-019-30 bottle of 30 33261-019-60 bottle of 60 Storage : Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
New Drug Application
Aidarex Pharmaceuticals LLC ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called "corticosteroids" and "anticoagulants" • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should Perskaitykite visą dokumentą
CELEBREX- CELECOXIB CAPSULE AIDAREX PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CELEBREX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CELEBREX. CELEBREX (CELECOXIB) CAPSULES INITIAL U.S. APPROVAL: 1998 WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ CARDIOVASCULAR RISK CELEBREX MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. ALL NSAIDS MAY HAVE A SIMILAR RISK. THIS RISK MAY INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK. _(5.1,14.6)_ CELEBREX IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. _(4, 5.1)_ GASTROINTESTINAL RISK NSAIDS, INCLUDING CELEBREX, CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL 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 ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL (GI) EVENTS. _(5.4)_ INDICATIONS AND USAGE CELEBREX 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 DOSE FOR THE SHORTEST DURATION CONSISTENT WITH TREATMENT GOALS FOR THE INDIVIDUAL PATIENT. (1, 5.1, 5.4) OA: 200 mg once daily or 100 mg twice daily (2.1, 14.1) RA: 100 to 200 mg twice daily (2.2, 14.2) JRA: 50 mg twice daily in patients 10–25 kg. 100 mg twice daily in patients more than 25 kg (2.3, 14.3) AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 Perskaitykite visą dokumentą