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Forsanec 120

Forsanec 120

etoricoxib

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
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, may be increased to max of 60 mg once daily if symptomatic relief is insufficient. RA, ankylosing spondylitis 60 mg once daily, may be increased to max of 90 mg once daily if symptomatic relief is insufficient. Once clinically stabilised, down-titration to 60 mg once daily may be appropriate. Acute gouty arthritis 120 mg once daily for 8 days. Post-op dental surgery pain 90 mg once daily, limited to max of 3 days. Patient w/ mild hepatic dysfunction (Child-Pugh score 5-6) Max: 60 mg once daily. Patient w/ moderate hepatic dysfunction (Child-Pugh score 7-9) Max: 30 mg once daily.
Administration
May be taken with or without food: May consider taking w/o food when rapid symptomatic relief is needed as onset of effect may be faster w/o food.
Contraindications
Hypersensitivity. Active peptic ulceration or GI bleeding; patients who experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking ASA or NSAIDs including COX-2 inhibitors; 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
Discontinue at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Risk of upper GI complications eg, perforations, ulcers or bleedings; thrombotic events especially MI & stroke; fluid retention, oedema & HTN; elevations of ALT &/or AST. May mask fever & other signs of inflammation. Patients w/ prior history of GI disease eg, ulceration & GI bleeding; significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; history of cardiac failure, left ventricular dysfunction, or HTN, & pre-existing oedema from any other reason; renal, hepatic, or cardiac dysfunction; dehydration. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Control HTN prior to treatment. Monitor BP w/in 2 wk after initiation of treatment & periodically thereafter. Discontinue use if signs of hepatic insufficiency occur, or if persistently abnormal LFTs (3 times ULN) are detected. Rehydrate patients prior to starting therapy. Concomitant use w/ any other NSAID or ASA; warfarin or other oral anticoagulants. Patients who experience dizziness, vertigo or somnolence should refrain from driving or operating machinery. Not recommended in women attempting to conceive. Elderly.
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. Nephrotoxicity including interstitial nephritis & nephrotic syndrome.
Drug Interactions
Increased prothrombin time/INR w/ oral anticoagulants eg, chronic warfarin therapy. May reduce effect of diuretics, ACE inhibitors & AIIA. May result in further deterioration of renal function including possible acute renal failure w/ ACE inhibitor or AIIA in patients w/ compromised renal function. May increase rate of GI ulceration or other complications w/ low-dose ASA. May increase nephrotoxic effect of cyclosporin or tacrolimus. Decreased renal excretion & therefore increased plasma levels of lithium. Increased plasma conc & reduced renal clearance of MTX. Increased steady state AUC0-24hr of ethinyl estradiol; unconjugated estrone, equilin, & 17-β-estradiol. Increased Cmax of digoxin. Decreased plasma conc w/ rifampicin (potent CYP inducer). Exercise caution when using concurrently w/ substrates of sulfotransferases (eg, oral salbutamol, minoxidil).
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
Forsanec 120 FC tab 120 mg
Packing/Price
28's (P1,260/box)
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