Rancelex Capsules 200 mg

Celecoxib

Symptomatic relief of OA, RA & ankylosing spondylitis. Management of acute pain in adults, & low back pain. Primary dysmenorrhea.

OA 200 mg/day as single dose. RA 200 mg bid. Ankylosing spondylitis 200 mg once daily. May be increased up to 400 mg daily after 6 wk. Management of acute pain & treatment of primary dysmenorrhea Initially 400 mg, followed by an additional 200 mg on the 1st day, if needed. Then, 200 mg bid on subsequent days. Low back pain 200 mg or 400 mg daily, administered as 200 mg single dose, or as 100 or 200 mg bid.

May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.

Hypersensitivity to celecoxib, aspirin or other NSAIDs including COX-2 inhibitors, & sulfonamides. Patients w/ asthma, urticaria; perioperative pain in the setting of CABG surgery, CHF (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease; estimated CrCl <30 mL/min. Inflammatory bowel disease.

Severe renal insufficiency. May cause an increased risk of serious adverse CV thrombotic events, MI, & stroke in chronic use. Consider treatment in patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Patients w/ HTN & known to be CYP2C9 poor metabolisers. Monitor BP during the initiation of therapy & throughout course of therapy. Fluid retention & edema; CHF is contraindicated. May cause serious GI events including bleeding, ulceration & perforation of the stomach, small & large intestine. Extreme caution in patients w/ history of PUD &/or GI bleeding. Concomitant use w/ aspirin, celecoxib, thiazides or loop diuretics, oral corticosteroids or anticoagulants, longer duration of NSAID therapy; smoking, alcohol, poor general health status. Closely monitor BP; patients w/ signs & symptoms of liver dysfunction; renal function. Renal papillary necrosis & other renal injury in long-term use. Not recommended in patients w/ advanced renal disease. Anaphylactic reactions & angioedema. Do not administer to patients w/ aspirin triad. Discontinue use at the 1st appearance of skin rash or any other sign of hypersensitivity; exfoliative dermatitis, SJS & TEN may occur; if consistent liver disease develops. Slowly taper corticosteroid therapy in patients on prolonged corticosteroid therapy. Check Hb & hematocrit if on long-term treatment. Pre-existing asthma. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Elderly & debilitated patients. Ped patients <2 yr & weighing <10 kg.

Sinusitis, URTI, UTI; allergy aggravated; insomnia; dizziness, hypertonia; MI; pharyngitis, rhinitis, cough, dyspnoea; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; flu-like symptoms.

Drugs known to inhibit CYP2C9. Increase plasma conc of dextromethorphan, antidepressants (tricyclics & SSRIs), neuroleptics, anti-arrhythmics. Increased risk of bleeding complications w/ warfarin. Increase plasma levels of lithium. Increased rate of GI ulceration or other complications w/ aspirin. May diminish antihypertensive effect of ACE inhibitors & AIIA. Increased plasma conc w/ fluconazole. Reduced natriuretic effect of furosemide & thiazides. Increased risk of adverse events w/ non-aspirin NSAID.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

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