Composition:

Each capsule contains:

Active ingredients:

Celecoxib ……………………….……… 100 mg or 200 mg

Indications:

Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks.

Dosage & administration:

As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

– Osteoarthritis:

The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In
some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase
efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options
should be considered.

– Rheumatoid arthritis:

The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

– Ankylosing spondylitis:

 

The recommended daily dose is 200 mg taken once daily or in two divided doses.
In a few patients, with insufficient relief from symptoms, an increased dose of 400mg once daily or in two divided doses may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
The maximum recommended daily dose is 400 mg for all indications. Celeborg Capsules may be taken with or without food.

Elderly:

(>65 years) as in younger adults, 200 mg per day should be used initially.The dose may, if needed, later be increased to 200 mg twice daily. Particular caution should be exercised in elderly with a body weight less than 50 kg.
– Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with
established moderate liver impairment with a serum albumin of 25-35 g/l. Experience in such patients is limited to cirrhotic patients.

– Renal impairment:

Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
– Children: Celecoxib is not indicated for use in children.
– CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose.

Package & storage:

-Carton box containing one or two blisters (PVC/Alu) each of 10 capsules and insert leaflet.
-Store at a temperature not exceeding 30˚C in dry place.
-Should not be used beyond the expiry date marked on the package.
-Keep out of the reach of children.
-Don’t use unless under physician supervision.

 

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