Coxbitor 200/Coxbitor 400

Coxbitor 200/Coxbitor 400

celecoxib

Manufacturer:

Lloyd

Distributor:

JustRight Healthcare
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Treatment of RA, OA & ankylosing spondylitis. Management of acute pain & dysmenorrhea. Coxbitor 200 Treatment of juvenile idiopathic arthritis; adjunctive treatment of adenomatous colorectal polyps.
Dosage/Direction for Use
Adult OA 200 mg daily given as single dose or in 2 divided doses, if necessary, 200 mg bid. RA 100-200 mg bid. Ankylosing spondylitis Initially 200 mg daily as single dose or in 2 divided doses. If no effect is observed after 6 wk on 400 mg daily should be given to alternate options. Treatment of pain & dysmenorrhea Initially 400 mg followed by an additional dose of 200 mg, if necessary. Coxbitor 200 Adjunctive treatment of adenomatous colorectal polyps 400 mg bid.
Administration
May be taken with or without food.
Contraindications
Should not be given in patients who have history of CVA, MI, CABG, uncontrolled HTN & CHF NYHA II-IV; patients w/ allergy to NSAIDS & w/ asthma. Hypersensitivity to celecoxib & sulfonamides. Coxbitor 200 Inflammatory bowel disease, renal impairment (CrCl <30 mL/min), severe hepatic impairment (Child-Pugh category C), dehydrated patients. Discontinue if signs or symptoms of organ toxicity develops. Coxbitor 400 Hypersensitivity to aspirin or other NSAIDS. Patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDS. Severe anaphylactoid reactions to NSAIDs. History of peri-op pain in setting CABG surgery.
Special Precautions
Patients w/ known CV disease; history of ischemic heart disease, peripheral arterial disease or cerebrovascular disease; significant risk factors for cardiovascular disease eg, HTN, hyperlipidemia & DM. Serious skin adverse events eg, exfoliative dermatitis, Stevens-Johnson syndrome (SJS) & toxic epidermal necrolysis (TEN); discontinue upon appearance of skin rash & signs of hypersensitivity. Pregnancy & lactation. Elderly (>65 yr of age). Coxbitor 400 Increase risk of GI bleeding in concomitant use w/ oral corticosteroids, anticoagulants, longer duration of NSAID therapy, smoking, alcohol & poor general health status. Fluid retention & edema in patients w/ CHF. Severe hepatic reactions including jaundice & fatal fulminant hepatitis, liver necrosis & hepatic failure; not recommended in patients w/ severe hepatic impairment. Long-term administration of NSAIDs may result to renal papillary necrosis. Impaired renal function, heart failure, liver dysfunction, diuretics, ACE-inhibitors, ARBs. Not used to substitute corticosteroid or treat corticosteroid insufficiency. Abrupt discontinuation may lead to exacerbation of corticosteroid-responsive illness. Patients w/ known or poor CYP2C9 metabolizers. Avoid in late pregnancy starting at 30 wk gestation; may cause premature closure of ductus arteriosus.
Adverse Reactions
Coxbitor 200 Serious skin reactions eg, exfoliative dermatitis, SJS & TEN; anaphylaxis & angioedema. Coxbitor 400 GI disturbances eg, GI discomfort, nausea & diarrhea.
Drug Interactions
Changes in plasma conc w/ drugs that inhibit or induce CYP450 isoenzyme CYP2C9. Increased plasma conc w/ fluconazole. May affect drugs metabolized by isoenzyme CYP2C9.
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
Coxbitor 400 cap 400 mg
Packing/Price
30's (P1,200/box, P40/cap)
Form
Coxbitor 200 cap 200 mg
Packing/Price
100's
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