Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)
SYDON LABS LLC
CELECOXIB
CELECOXIB 200 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] Celecoxib is inCelecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)] Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)] Celecoxib is contraindicated: • In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. • In patients who have demonstrated allergic
Celecoxib capsules 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to offwhite colored granular powder. NDC 69399-182-81 bottle of 100 capsules Celecoxib capsules 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to offwhite colored granular powder NDC 69399-183-81 bottle of 100 capsules Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder NDC 69399-184-81 bottle of 100 capsules NDC 69399-184-85 bottle of 500 capsules Celecoxib capsules 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder. NDC 69399-185-81 bottle of 100 capsules Storage: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SYDON LABS LLC ---------- MEDICATION GUIDE 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 n Soma hati kamili
CELECOXIB 200 MG- CELECOXIB CAPSULE SYDON LABS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION CELECOXIB 200 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CELECOXIB SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CELECOXIB. CELECOXIB CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ CARDIO VASC ULARRISK CELECOXIB 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) CELECOXIB 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 CELECOXIB, 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 Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: (1) • Osteoarthritis (OA) (1.1)R • heumatoid 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) (1) DOSAGE AND ADMINISTRATION USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH TREATMENT GOALS FOR THE INDIVIDUAL PATIENT. (1, 5.1, 5.4) (2) • 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 to 25 kg. 100 mg twice daily in patients more than 25 kg (2.3, 14.3) • AS: 200 mg once dai Soma hati kamili