Setorib 120 mg Tablet

Setorib 120 mg Tablet

DESCRIPTION

SETORIB (Etoricoxib) is a Non-Steroidal Anti-Inflammatory Drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. 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.

COMPOSITION

SETORIB 60 : Each film-coated tablet contains Etoricoxib INN 60 mg.

SETORIB 90: Each film-coated tablet contains Etoricoxib INN 90 mg.

SETORIB 120: Each film-coated tablet contains Etoricoxib INN 120 mg.

INDICATION

SETORIB (Etoricoxib) is indicated for relief of pain and inflammation in -

• osteoarthritis

• rheumatoid arthritis

• ankylosing spondylitis

• other chronic musculoskeletal disorders

• acute gout

• dysmenorrhoea &

• following dental surgery.

DOSAGE AND ADMINISTRATION

Adult and adolescent over 16 years:

• osteoarthritis, dysmenorrhoea & chronic musculoskeletal disorders: 60 mg, once daily.

• rheumatoid arthritis: 90 mg, once daily.

• ankylosing spondylitis: 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.

OR AS DIRECTED BY THE PHYSICIAN.

CONTRAINDICATION

Etoricoxib is contraindicated to patients with known hypersensitivity to Etoricoxib or to any of the excipients of this medicinal product. Patients with active peptic ulceration or gastro-intestinal (GI) bleeding, severe hepatic dysfunction. Patient having inflammatory bowel disease and severe congestive heart failure. Children and adolescents under 16 years of age.

PRECAUTION

Decrease kidney function and liver function, dehydration, hypertension, history of heart failure, perforation and people over 65 years of age.

SIDE EFFECT

Dry mouth, taste disturbance, mouth ulcers, constipation, flatulence, appetite and weight changes, chest pain, paraesthesia, fatigue, influenza-like syndrome & myalgia.

USE IN PREGNANCY AND LACTATION

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.

DRUG

INTERACTION

Oral anticoagulants, diuretics and ACE inhibitors, Acetylsalicylic acid,

Cyclosporin, Tacrolimus, Lithium, Birth control pills, Prednisone/Prednisolone,

Digoxin, Ketoconazole, Rifampicin, and Antacids have interaction with Etoricoxib.

SUPPLY

SETORIB 60 : Each box contains 4 x 10 tablets in blister strip.

SETORIB 90 : Each box contains 3 x 10 tablets in blister strip.

SETORIB 120 : Each box contains 2 x 10 tablets in blister strip.