Advertisement
Advertisement
Arthoxib

Arthoxib

etoricoxib

Manufacturer:

Pond Chemical

Distributor:

Masa Lab
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Adults & adolescents ≥16 yr for symptomatic relief of OA, RA, ankylosing spondylitis, pain & signs of inflammation associated w/ acute gouty arthritis; short-term treatment of moderate pain associated w/ dental surgery.
Dosage/Direction for Use
OA 30 mg once daily. Max dose: 60 mg daily. RA & ankylosing spondylitis 60 mg once daily. Max dose: 90 mg daily. Acute gouty arthritis Recommended & max dose: 120 mg once daily. Max duration: 8 days. Post-op dental pain Recommended & max dose: 90 mg once daily. Max duration: 3 days. Mild hepatic dysfunction (Child-Pugh score 5-6) Max dose: 60 mg once daily. Moderate hepatic dysfunction (Child-Pugh score 7-9) Max dose: 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active peptic ulceration or GI bleeding; inflammatory bowel disease; CHF (NYHA II-IV); established ischaemic heart, peripheral arterial, &/or cerebrovascular disease. Patients who experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking ASA or NSAIDs including COX-2 inhibitors; w/ inadequately controlled HTN whose BP is persistently elevated >140/90 mmHg. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Serious hypersensitivity (eg, anaphylaxis & angioedema) & skin (eg, exfoliative dermatitis, SJS & TEN) reactions. Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if signs of hepatic insufficiency occur, or if persistent abnormal LFTs (3x ULN) are detected; if GI, CV, renal or hepatic deterioration occurs during treatment. Not a substitute for ASA for CV thromboembolic disease prophylaxis. Risk of thrombotic events (MI & stroke). Upper GI complications (perforations, ulcers or bleedings); fluid retention, edema & HTN; new onset or recurrent CHF; elevated ALT &/or AST (≥3x ULN). Increased risk of skin reactions in patients w/ history of any drug allergy. May mask fever & other signs of inflammation. Patients w/ risk factors for CV events (eg, HTN, hyperlipidaemia, DM & smoking); dehydration; pre-existing oedema; at risk of developing GI complication w/ NSAIDs or w/ prior history of GI disease eg, ulceration & GI bleeding; history of cardiac failure, left ventricular dysfunction, or HTN. Re-evaluate periodically the need for symptomatic relief & response to therapy, especially in patients w/ OA. Control HTN before treatment. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure or cirrhosis; BP w/in 2 wk after initiation of treatment & periodically thereafter; any patient w/ symptoms &/or signs suggesting liver dysfunction or w/ abnormal LFT. Rehydrate patients prior to starting therapy. Increased risk of GI adverse effects (GI ulceration or other GI complications) w/ concomitant ASA (even at low dose). Concomitant use w/ other NSAIDs; warfarin or other oral anticoagulants. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Moderate hepatic dysfunction (Child-Pugh score 7-9). Not recommended in women attempting to conceive. Discontinue use during pregnancy. Not to breastfeed during treatment. 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. SJS, TEN.
Drug Interactions
Increased prothrombin time INR w/ warfarin. Decreased plasma AUC w/ rifampin. Increased plasma conc & reduced renal clearance of MTX. Reduced effect of diuretics, ACE inhibitors & AIIA. Further deterioration of renal function including possible acute renal failure w/ ACE inhibitors or AIIA in patients w/ compromised renal function. Increased plasma lithium levels. Increased rate of GI ulceration or other complications w/ low-dose ASA. May increase nephrotoxic effect of cyclosporin or tacrolimus. Increased steady state AUC0-24hr of estradiol; unconjugated estrone, equilin & 17-β-estradiol. Concomitant use w/ other drugs primarily metabolised by human sulfotransferases eg, oral salbutamol & minoxidil. Decreased plasma conc w/ rifampicin.
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
Arthoxib FC tab 120 mg
Packing/Price
5 × 5's
Form
Arthoxib FC tab 60 mg
Packing/Price
3 × 10's
Form
Arthoxib FC tab 90 mg
Packing/Price
3 × 10's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement