Dosage and administration	Dosage: As the cardiovascular risks of etoricoxib may increase with dose and treatment duration, the lowest effective daily dose should be used and for the shortest possible duration. Efficacy of the treatment with etoricoxib should be assessed, especially in patients with osteoarthritis. Acute gouty arthritis: (Acute gout attacks) 120mg once daily, etoricoxib should be used only for the acute symptomatic period, and duration of treatment should not exceed 8 days. Elderly patients: No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients. Patients with hepatic impairment: Agietoxib 120mg should not be used in patients with hepatic impairment. Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance ≥ 30ml/min. Etoricoxib is contraindicated in patients with creatinine clearance < 30ml/min. Administration: AGIETOXIB is administered orally with or without food.
Contraindications	Hypersensitivity to etoricoxib or any of the excipients of the product. Peptic ulcers or gastrointestinal bleeding. Patients suffering from bronchospasms, acute rhinitis, nasal polyps, neuroangioedema, urticaria or allergic reactions after taking acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitor (cyclooxygenase-2). Severe hepatic dysfunction (serum albumin < 25g/l or Child-Pugh score ≥ 10). Renal failure Creatinine clearance < 30ml/min. Inflammatory bowel disease. Congestive heart failure. Patients with hypertension whose blood pressure is persistently over 140/90mmHg and has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. Pregnancy and lactation. Children under 16 years of age.
Warnings and precautions for use	Caution should be exercised with patients with blood clotting disorder, dehydration, patients with a history of heart failure, ischemic heart disease, left ventricular dysfunction, hypertension, and patients with edema due to different reasons. Patients with renal impairment, hepatic impairment, heart failure, hypertension. Elderly patients. Because cardiovascular risk can increase with the dose and duration of treatment with selective COX-2 inhibitors, AGIETOXIB should be used at the lowest effective daily dose for the shortest possible duration to minimize the risk of adverse events. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. Cardiovascular effect and risk of cardiovascular thrombotic events: Non-steroidal anti-inflammatory drugs (NSAIDs), different from aspirin, with systemic effects may cause an increased risk of cardiovascular thrombotic events, including heart attack and stroke which can be fatal. This risk may occur early within the first few weeks of treatment and increase with duration of exposure. The risk of cardiovascular thrombotic events has been mainly observed at high doses. The occurrence of cardiovascular events should be re-evaluated periodically, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and should meet the doctor as soon as these symptoms occur. AGIETOXIB 120 should be used at the lowest effective daily dose for the shortest possible duration to minimize the risk of adverse events. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely during post-marketing surveillance when NSAIDs were combined with some selective COX-2 inhibitors. Patients appear to be at highest risk for these reactions early in the course of therapy with the onset of the reaction occurring in the majority of cases within the first month of treatment. Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib. Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of allergy. Etoricoxib should be discontinued at the first appearance of skin rash, mucosal injury. This medicine contains lactose: Patients with rare hereditary problems of galactose intolerance, Lapp lactase enzyme deficiency or glucose-galactose malabsorption should not take this medication.
Recommendation for pregnancy and breastfeeding	Pregnancy: Avoid using this drug during pregnancy because of the safety of the fetus. Lactation: Etoricoxib should not be used during lactation.
Effects on ability to drive and use machines	Etoricoxib may cause dizziness, headache or drowsiness, which can affect the ability to drive and operate machines.
Interactions, incompatibilities of medicine	Warfarin: In patients stabilised on chronic warfarin therapy, the administration of etoricoxib 120mg daily was associated with an approximate 13% increase in prothrombin time International Normalised Ratio (INR). INR values should be frequently monitored prior to initiating or changing the treatment with etoricoxib, especially in the first few days in patients taking warfarin or similar drugs. Rifampin: Co-administration of etoricoxib with rifampicin, a potent inducer of hepatic metabolism, produced a 65% decrease in etoricoxib plasma area under the curve (AUC). This interaction should be considered when etoricoxib is co-administered with rifampicin. Methotrexate: Studies investigating the effects of etoricoxib 60, 90 or 120mg administered once daily in patients receiving methotrexate led to different results, monitoring for methotrexate-related toxicity should be considered when etoricoxib dose greater than 90mg daily is used concurrently with methotrexate. Diuretics, ACE inhibitors and angiotensin II antagonists: Reports have shown that NSAIDs, including COX-2 inhibitors, can reduce the blood pressure-lowering effect of diuretics, ACE inhibitors, and AIIAs. This interaction should be considered in patients receiving etoricoxib simultaneously with these agents. In patients with impaired renal function (e.g, elderly patients or patients with fluid loss, including those on diuretic therapy) who are being treated with nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, co-administration of etoricoxib with ACE inhibitors or AIIAs may lead to further impairment of renal function, including acute renal failure. These effects are usually reversible. Therefore, the combination should be used with caution, especially in the elderly. Lithium: Etoricoxib decreases lithium renal excretion and therefore increases lithium plasma levels. When etoricoxib and lithium are administered concurrently, patients should be observed carefully to detect signs of lithium toxicity. Aspirin: There is no evidence that concurrent use with aspirin reduces the risk of cardiovascular adverse events associated with COX-2 inhibitor use, including etoricoxib. However, co-administration of etoricoxib with low-dose aspirin may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone. At steady state, etoricoxib 120mg once daily had no effect on the anti-platelet activity of acetylsalicylic acid at low dose (81mg once daily) (See Precautions section) Oral contraceptives: Etoricoxib 120mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1mg norethindrone for 21 days, concomitantly or separated by 12 hours increased the steady state AUC 0-24 hours of EE by 50 to 60%. This increase in EE concentration should be considered when selecting an oral contraceptive for coadministration with etoricoxib. An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g. venous thrombo-embolic events in women at risk). Hormone replacement therapy: Estrogen in oral contraceptives or hormone replacement therapy may increase the risk of side effects when taken with etoricoxib. Others: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone or digoxin. Antacids and ketoconazole (a potent inhibitor of CYP3A4) did not have any clinically important effect on pharmacokinetics of etoricoxib.
Undesirable effects (ADRs)	Attention should be paid to the risk of thrombotic cardiovascular events (see Conditions where caution should be taken), some of the following side effects may occur: Common: Dizziness, headache, gastrointestinal disorders, diarrhea, dyspepsia, epigastric pain, asthenia, flu-like disease, muscle pain, elevated liver enzymes, swelling of legs and feet. Uncommon: Skin reactions, rash, hallucinations, anxiety, depression, insomnia, paresthesia, drowsiness, blurred vision, ringing in the ears, heart failure, hypertension, thrombocytopenia.
Overdose and management	Overdose: In clinical studies, administration of single doses of etoricoxib up to 500mg and multiple doses up to 150mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases. The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, renovascular events). Management: In the event of overdose, it is reasonable to employ the usual supportive measures, e.g. remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required. Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Pharmacodynamic properties	Etoricoxib is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, antipyretic activity. It is an oral potent selective cyclooxygenase-2 (COX-2) inhibitor. NSAIDs act by inhibiting the activity of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is an enzyme involved in the production of prostaglandins, in response to injury or certain diseases. The prostaglandins cause pain, swelling and inflammation. Because NSAIDs inhibit the production of prostaglandins, they are effective in relieving pain and inflammation.. Etoricoxib selectively inhibits cyclooxygenase (COX-2) resulting in reducing these clinical signs and symptoms and gastrointestinal toxicity and has no effect on platelet function. In all clinical pharmacology studies, etoricoxib shows dose dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150mg daily.
Pharmacokinetic properties	Orally administered etoricoxib is well absorbed. The mean oral bioavailability is approximately 100% and peak plasma concentrations are reached at approximately 1 hour. Etoricoxib is approximately 90% bound to plasma proteins without causing significant changes in the level and rate of absorption when (etoricoxib is) taken with food. Etoricoxib is metabolized primarily in the liver by the cytochrome P450 (CYP) 3A4 and excreted in the urine, mostly as metabolites. None of these metabolites has significantly inhibitory effect on COX-2 or COX-1. The elimination half-life of etoricoxib is approximately 22 hours.
Storage conditions, shelf-life, quality specification of the medicine	Storage conditions: Protect from humidity and light, below 30 degrees C. Shelf – life: 36 months from the manufacture date. Quality specification: In house specification.

AGIETOXIB®120

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AGIETOXIB^®120