Composition
Ezepain 90 mg tablet: Each film coated tablet contains Etoricoxib INN 90 mg.
Ezepain 120 mg tablet: Each film coated tablet contains Etoricoxib INN 120 mg.

Pharmacology
Ezepain is the preparation of Etoricoxib. It is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. It is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor within and above the clinical dose range. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by Etoricoxib decreases these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.

Indication
• Pain and inflammation in osteoarthritis, rheumatoid arthritis and other chronic musculoskeletal disorders
• Acute gout
• Pain of dysmenorrhoea and
• Pain following dental surgery.

Dosage & administration
Adult and adolescent over 16 years: Osteoarthritis, chronic musculoskeletal disorders & dysmenorrhoea: 60 mg, once daily. Rheumatoid arthritis: 90 mg, once daily. Pain following dental surgery & acute gout: 120 mg, once daily. Safety and effectiveness of Etoricoxib in paediatric patients have not been established.

Contra-indication
Etoricoxib is contraindicated to patients with known hypersensitivity to any component of this product, patient with inflammatory bowel disease, severe congestive heart failure.

Warning & precaution
In patients with advanced renal disease, treatment with it is not recommended. Clinical experience in patients with estimated creatinine clearance of <30 ml/min is very limited. If therapy with it must be initiated in such patients, close monitoring of the patient's renal function is advisable. Caution should be used when initiating treatment with it in patients with considerable dehydration. It is advisable to rehydrate patients prior to starting therapy with it. The possibility of fluid retention, oedema or hypertension should be taken into consideration when it is used in patients with pre-existing oedema, hypertension, or heart failure. Independent of treatment, patients with a prior history of GI perforation, ulcers and bleeding (PUB) and patients greater than 65 years of age are known to be at a higher risk for a PUB.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for persistently abnormal liver function tests. If persistently abnormal liver function tests (three times the upper limit of normal) are detected, it should be discontinued. It should be used with caution in patients who have previously experienced acute asthmatic attacks, urticaria, or rhinitis, which were precipitated by salicylates or non-selective cyclooxygenase inhibitors. It may mask fever, which is a sign of infection. The physician should be aware of this when using it in patients being treated for infection.

Side effects
Side-effects may include dry mouth, taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight changes, chest pain, fatigue, influenza-like syndrome, myalgia etc may occur.

Use in pregnancy & lactation
As with other drugs known to inhibit prostaglandin synthesis, use of it should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus. It should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whether this drug is excreted in human milk.

Use in children & adolescents
Etoricoxib is contra-indicated in children and adolescents under 16 years of age.

Drug interaction
Oral anticoagulants, diuretics and ACE inhibitors, Acetylsalicylic acid, Cyclosporin and Tacrolimus, Lithium, Methotrexate, oral contraceptives, Prednisone/Prednisolone, Digoxin, drugs metabolized by sulfotransferases (Ethinyl Estradiol), drugs metabolized by CYP isoenzymes, Ketoconazole, Rifampicin, and Antacids have interaction with Etoricoxib.

Overdose
In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/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, cardiorenal events).

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.

Storage
Keep out of the reach of children. Keep below 30°C, protect from light.

Packing
Ezepain 90 mg tablet: Each box contains 3x10's tablet in blister pack.
Ezepain 120 mg tablet: Each box contains 2x10's tablet in blister pack.