Etorix Tablets

Class: NSAIDs, selective COX-2 inhibitors

Manufacturer: Eskayef Pharmaceutical Ltd, 400 Squibb Road, Tongi Industrial Area, Tongi Gazipur 1711, Bangladesh

Dosage Form: Tablet (film coated)

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Uses:

Pain and inflammation in osteoarthritis, in rheumatoid arthritis, and in other chronic musculoskeletal disorders; acute gout; pain of dysmenorrhoea and pain following dental surgery.

Dosage:

Adults and adolescents over 16 years

• In case of osteoarthritis, dysmenorrhea, chronic musculoskeletal disorders: 60mg once daily.
• In case of rheumatoid arthritis: 90mg once daily.
• In case of pain following dental surgery, acute gout: 120mg once daily

Safety and effectiveness of etoricoxib in pediatric patients have not been established.

Side Effects:

Side effects of etoricoxib are dry mouth, taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight changes, chest pain, fatigue, paraesthesia, influenza-like syndrome, myalgia.

Warnings & Precautions:

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 of a PUB. A patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be elevated for persistent 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.

Overdose

In clinical studies, administration of single dose 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 of etoricoxib, although adverse experiences were not reported in the majority of cases. The most frequently observed adverse experience 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.

Etoricoxib is not dialysable by hemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.

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 of the foetus. It is not known whether this drug is excreted in human milk.

Drug Interactions:

Etoricoxib can interact with various medications, affecting their effectiveness or increasing the risk of side effects. It may reduce the effectiveness of hormonal contraceptives, so alternative birth control methods are recommended. When taken with cyclosporine, there is a significant risk of liver toxicity, making co-administration contraindicated. Rifampin can lower the effectiveness of Etoricoxib, potentially reducing its intended benefits.

Contraindications:

It is contraindicated in inflammatory bowel syndrome, severe congestive heart failure.

Price: Ksh

Notes:

Ref PM06402 V02