Category : NSAIDS, ANTIPYRETICS, ANALGESICS

Name : CELECOXIB     Type & Dosage : Cap. ; 100 mg Package : 30

Pharmacologic Category Nonsteroidal Anti–inflammatory Drug (NSAID), COX-2 Selective Mechanism Of Action Celecoxib inhibits the activity of the enzyme cyclooxygenase-2 (COX-2), resulting in a decreased formation of precursors of prostaglandins. Indications Celecoxib is a nonsteroidal anti – inflammatory drug with anti–inflammatory, analgesic, and antipyretic therapeutic effects. Celecoxib is indicated for osteoarthritis,rheumatoid arthritis, acute pain, primary dysmenorrhea and familial adenomatous polyposis. Side Adverse Effects a– Those indicating need for medical attention : Edema ; Skin rash ; Upper respiratory tract infection ; Bronchitis ; Dyspnea ; Gastritis ; Gastroenteritis ; Gastrointestinal bleeding or ulceration ; Influenza-like symptoms ; Tachycardia ; Weight gain. b- Those indicating need for medical attention only if they continue or are bothersome: Back pain ; Diarrhea ; Dizziness ; Dyspepsia ; Flatulence ; Headache ; Insomnia ; Nausea ; Pharyngitis ; Rhinitis ; Sinusitis ; Stomach pain ; Anxiety ; Anorexia ; Arthralgia ; Asthenia ; Blurred vision ; Constipation; Depression ; Dry mouth ; Dysphagia ; Esophagitis ; Fatigue ; Fever ; Hot flashes ; Increased sweating ; Nervousness ; Palpitations ; Paresthesias ; Somnolence ; Taste perversion ; Tendinitis ; Tinnitus; Vertigo ; Vomiting . Contraindications Hypersensitivity to celecoxib and component of the formulation, sulfonamides, aspirin, or other NSAIDs; Nasal polyps associated with aspirin–induced bronchospasm; pregnancy (3rd trimester); Patients immediately post-operative from coronary artery bypass (CABG) surgery. Warnings Precautions Use with caution in patients with a history of GI bleeding , decreased renal function , hepatic disease , CHF , hypertension , asthma , and known or suspected deficiency of cytochrome p450 isoenzyme 2C9.Celecoxib has been linked to an increased risk of serious cardiovascular events (such as heart attack or stroke) which appears to be a risk shared by all NSAIDs (excluding aspirin) . If celecoxib is selected for an individual patient , FDA encourages use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Pregnancy FDA pregnancy category C . Celecoxib may cause premature closure of the ductus arteriosus. Therefore , use of celecoxib is not recommended during late pregnancy. Breast Feeding Celecoxib enters breast milk / not recommended. Drug Interactions Concurrent use with celecoxib may decrease the antihypertensive effects of ACE inhibitors . Because of celecoxib – induced GI ulceration or irritation , use with low–dose aspirin and avoidance of ethanol consumption is recommended . If celecoxib is coadministered with fluconazol , the dose of celecoxib should be initiated at the lowest recommended dose . Plasma levels of lithium are increased when used with celecoxib; monitoring of lithium concentrations is recommended when treatment is initiated and when treatment with celecoxib is discontinued . Natriuretic effects of thiazide , furosemide and other loop diuretics may be decreased by celecoxib . Bleeding events and increased prothrombin time have been reported with concomitant use of warfarin and celecoxib (especially in the elderly). Monitoring Parameters Careful monitoring of ALT and AST is recommended in patients with signs and symptoms of hepatic function impairment . Hematocrit or hemoglobin monitoring is recommended in patients who have developed signs and symptoms of anemia or blood loss during prolonged therapy with celecoxib. Dietary Considerations Lower doses (200 mg twice daily) may be taken without regard to meals. Larger doses should be taken with food to improve absorption. Administration And Dosage Osteoarthritis : Oral , 200 mg daily as a single dose or 100 mg twice a day . Rheumatoid arthritis : Oral , 100 – 200 mg twice a day . Familial adenomatous polyposis , Acute pain and primary dysmenorrhea : Oral , Initial dose : 400 mg , allowed by an additional 200 mg if needed on day 1 ; Maintenance dose : 200 mg twice a day . It is recommended that therapy with celecoxib be initiated at the lowest recommended dose in elderly patients less thon 50 kg of body weight . How Supplied Capsule: 100 mg Storage Store at 25°C (77° F) References USP DI, 2004 Up To Date, Vol. 13.1 (2005) Martindale, The Complete Drug Reference, 33 rd edition 2002