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Coxsan

Coxsan

etoricoxib

Manufacturer:

Hiral Labs

Distributor:

Sannovex
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis, & the pain & signs of inflammation associated w/ acute gouty arthritis in adults & adolescents ≥16 yr. Short-term treatment of moderate pain associated w/ dental surgery in adults & adolescents ≥16 yr.
Dosage/Direction for Use
OA 30 mg once daily. Increased dose of 60 mg once daily may increase efficacy in some patients w/ insufficient relief of symptoms. Max: 60 mg daily. RA & ankylosing spondylitis 60 mg once daily. Increased dose of 90 mg once daily may increase efficacy in some patients w/ insufficient relief of symptoms. Down-titrate to 60 mg once daily once patient is clinically stabilised. Max: 90 mg daily. Acute gouty arthritis 120 mg once daily for 8 days. Max: 120 mg daily, limited to a max of 8 days treatment. Post-op dental surgery pain 90 mg once daily, limited to a max of 3 days. Some patients may require other post-op analgesia in addition to treatment during the 3-day treatment period. Max: 90 mg daily. Patient w/ mild hepatic dysfunction (Child-Pugh score 5-6) Max of 60 mg once daily, moderate hepatic dysfunction (Child-Pugh score 7-9) Max of 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ history of CVA, MI, CABG, uncontrolled HTN, or CHF (NYHA II-IV). Active peptic ulceration or GI bleeding. Patients who, after taking ASA or NSAIDs including COX-2 inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions. Inflammatory bowel disease. CHF (NYHA II-IV). Patients w/ HTN whose BP is persistently elevated >140/90 mmHg & has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Not to be given to patients w/ allergy to NSAIDs & those w/ asthma. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Consider discontinuation of treatment in case of deterioration in any organ system functions. Caution when initiating treatment in patients w/ dehydration. Rehydrate patients prior to starting therapy. Risk of upper GI complications (perforations, ulcers or bleedings); fluid retention, oedema & HTN. May be associated w/ risk of thrombotic events (especially MI & stroke); new onset or recurrent CHF; more frequent & severe HTN. Reports of ALT &/or AST elevations (approx ≥3 times ULN). May mask fever & other signs of inflammation. May cause reduction in prostaglandin formation &, secondarily, in renal blood flow, & thereby impair renal function, under conditions of compromised renal perfusion. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Monitor BP w/in 2 wk after initiation of treatment & periodically thereafter. If BP rises significantly, consider alternative treatment. Monitor any patients w/ symptoms &/or signs suggesting liver dysfunction, or in whom an abnormal LFT has occurred. Maintain medically appropriate supervision in elderly & in patients w/ renal, hepatic, or cardiac dysfunction. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Caution when co-administering w/ warfarin or other oral anticoagulants. Not recommended in women attempting to conceive.
Adverse Reactions
Abdominal pain. Alveolar osteitis; oedema/fluid retention; dizziness, headache; palpitations, arrhythmia; HTN; bronchospasm; constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; increased ALT & AST; ecchymosis; asthenia/fatigue, flu-like disease.
Drug Interactions
Increase in prothrombin time INR w/ oral anticoagulants. May reduce effect of diuretics & other antihypertensive drugs. Risk of further renal function deterioration including possible acute renal failure, which is usually reversible, w/ ACE inhibitors & AIIA in some patients w/ compromised renal function. May result in increased rate of GI ulceration or other complications w/ low-dose ASA. May increase nephrotoxic effect of cyclosporin or tacrolimus. Increased plasma levels of lithium. May increase plasma conc of MTX. Increased steady state AUC0-24hr & serum conc of ethinyl estradiol in OC. Increased mean steady state AUC0-24hr of unconjugated estrone, equilin, & 17-β-estradiol in HRT. Increased Cmax of digoxin. Exercise care when concurrently administering w/ drugs primarily metabolised by human sulfotransferases (eg, oral salbutamol & minoxidil). Decreased plasma conc w/ rifampicin (potent CYP inducer).
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Coxsan FC tab 120 mg
Packing/Price
30's
Form
Coxsan FC tab 60 mg
Packing/Price
30's
Form
Coxsan FC tab 90 mg
Packing/Price
30's
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