Oricox Tablet 120mg

PRESENTATION

Oricox 120: Each tablet contains Etoricoxib INN 120 mg.

DESCRIPTION

Oricox 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

INDICATIONS

• 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:

In case of osteoarthritis, dysmenorrhoea, chronic musculoskeletal disorders, 60 mg once daily.

In case of rheumatoid arthritis 90 mg once daily.

In case of pain following dental surgery, acute gout 120 mg once daily.

Safety and effectiveness of Etoricoxib in paediatric patients have not been established.

SIDE EFFECTS

Side-effects may include dry mouth, taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight changes, chest

pain, fatigue, paraesthesia, influenza-like syndrome, myalgia.

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 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.

USE IN PREGNANCY & LACTATION

Pregnancy: 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.

Lactation: It is not known whether this drug is excreted in human milk.

COMMERCIAL PACK

Oricox 60: Each box contains 3 blister strips of 10 Tablets.

Oricox 90: Each box contains 3 blister strips of 10 Tablets.

Oricox 120: Each box contains 2 blister strips of 10 Tablets.