Cecoxza 400

Cecoxza 400

celecoxib

Manufacturer:

Hetero Labs

Distributor:

Zuellig Pharma

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis. Symptomatic relief of juvenile RA in patients ≥2 yr. Reduction of adenomatous colorectal polyps in adults w/ familial adenomatous polyposis (FAP). Management of acute pain in adults. Primary dysmenorrhea.
Dosage/Direction for Use
Adult OA 200 mg daily as a single dose or 100 mg bid. RA 100-200 mg bid. Ankylosing spondylitis 200 mg daily as single or divided doses. If an effect is observed after 6 wk 400 mg daily may be considered. Reduction of the number of adenomatous colorectal polyps in adult w/ familial adenomatous polyposis 400 mg bid. Management of acute pain & treatment of primary dysmenorrhea Initially 400 mg, followed by 200 mg dose if needed on the 1st day. Subsequently, 200 mg bid as needed. Ped patient ≥2 yr weighing ≥25 kg Juvenile RA 100 mg bid.
Administration
May be taken with or without food: May be given w/ or w/o meals, but doses for adenomatous colorectal polyps must be given w/ meals.
Contraindications
Hypersensitivity to celecoxib, aspirin or other NSAIDs. Patients w/ allergic-type reactions to sulfonamides. Patients who have experienced asthma, urticarial or allergic-type reactions in aspirin or NSAIDs. Peri-op pain treatment in CABG surgery.
Special Precautions
Discontinue use at 1st appearance of skin rash or any other signs of hypersensitivity; if liver disease or systemic manifestations eg, eosinophilia, rash develops. Not a substitute for aspirin for CV prophylaxis. Increased risk of serious CV thrombotic events, MI & stroke. Patients w/ prior history of PUD or GI bleeding or inflammation or other risk factors associated w/ PUD eg, smoking, use of alcohol or oral corticosteroids. Patients w/ HTN; CHF & fluid retention; preexisting asthma. Patients known or suspected to be CYP2C9 poor metabolizers. Not to be given in patients w/ aspirin triad. Serious skin infections eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Closely monitor BP during therapy. Periodically check CBC, Hb, hematocrit in patients on long-term treatment w/ NSAIDs. Avoid abrupt discontinuation. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ oral anticoagulants. Not recommended w/ severe hepatic impairment. Moderate hepatic impairment (Child-Pugh class B). Avoid use during 3rd trimester of pregnancy. Lactation. Ped patient w/ systemic onset juvenile RA. Elderly or debilitated patients.
Adverse Reactions
Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting; aggravated HTN, angina pectoris, coronary artery disorder, MI; aggravated allergy, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushed, influenza-like symptoms, pain, peripheral pain; leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo; deafness, tinnitus; palpitation, tachycardia; abnormal hepatic function, increased SGOT & SGPT; increased BUN, CPK, creatinine, NPN, alkaline phosphatase & wt, hypercholesterolemia, hyperglycemia, hypokalemia; arthralgia, arthrosis, myalgia, synovitis, tendinitis; ecchymosis, epistaxis, thrombocythemia; anorexia, anxiety, increased appetite, depression, nervousness, somnolence; anemia; bronchitis, bronchospasm; aggravated bronchospasm, coughing, dyspnea, laryngitis, pneumonia; alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous & maculopapular, skin disorder, dry skin, increased sweating, urticaria; cellulitis, contact dermatitis; albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus.
Drug Interactions
Concomitant use w/ drugs that inhibit CYP2C9. Increased risk of bleeding complications w/ warfarin. Increase lithium plasma levels. Increased GI ulceration w/ aspirin. Diminished antihypertensive effect of ACE inhibitors & angiotensin II antagonists. Concomitant use w/ NSAIDs including selective COX-2 inhibitors. Increased plasma conc w/ fluconazole. Reduced natriuretic effect of furosemide & thiazides.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Cecoxza 400 cap 400 mg
Packing/Price
6 × 10's
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