Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
Direct Rx
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)] 1.1 Osteoarthritis (OA) CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis (JRA) CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis (AS) CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain (AP) CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea (PD) CELEB
CELEBREX 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as: NDC Number Size 0025-1515-01 bottle of 60 CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as: NDC Number Size 0025-1520-31 bottle of 100 0025-1520-51 bottle of 500 0025-1520-34 carton of 100 unit dose 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 0025-1525-31 bottle of 100 0025-1525-51 bottle of 500 0025-1525-34 carton of 100 unit dose CELEBREX 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as: NDC Number Size 0025-1530-02 bottle of 60 0025-1530-01 � carton of 100 unit dose Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
New Drug Application
Direct Rx ---------- SPL MEDGUIDE SECTION 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 shou Կարդացեք ամբողջական փաստաթուղթը
CELEBREX- CELEBREX CAPSULE DIRECT RX ---------- CELEBREX BOXED WARNING SECTION WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKSCardiovascular Risk CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (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 events. ( 5.4) INDICATIONS & USAGE SECTION 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)] 1.1 Osteoarthritis (OA) CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis (JRA) CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis (AS) CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain (AP) CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea (PD) CELEBREX is indicated for the treatment of Կարդացեք ամբողջական փաստաթուղթը