COXIGET Capsule Ref.[115702] Active ingredients: Celecoxib

For osteoarthritis and rheumatoid arthritis, the lowest dose of COXIGET (Celecoxib) should be sought for each patient. These doses can be given without regard to timing of meals. COXIGET (Celecoxib) can be taken with or without food.

Osteoarthritis

For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily. If necessary a dose of 200 mg twice daily may be used. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

Rheumatoid arthritis

For relief of the signs and symptoms of rheumatoid arthritis the recommended oral dose is 100 mg 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. Dose can be increased to 400 mg once daily or in two divided doses in patients with insufficient relief of symptoms. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

Juvenile rheumatoid arthritis

For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients >10kg to <25kg the recommended dose is 50 mg twice daily. For patients >25kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a COXIGET (Celecoxib) capsule can be added to apple sauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C-8°C).

Management of acute pain and treatment of primary dysmenorrhea

The recommended dose of COXIGET (Celecoxib) is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed or 400 mg once daily.

Familial adenomatous, polyposis (FAP)

Usual medical care for FAP patients should be continued while on COXIGET (Celecoxib). To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg twice per day to be taken with food.

Elderly patients (>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 50kg.

Hepatic insufficient patients

The daily recommended dose of COXIGET (Celecoxib) capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by approximately 50%.

Poor metabolizers of CYP2C9 substrates

Consideration should be given to starting treatment at half the lowest recommended dose in these patients. Consideration should also be given to using alternative management in JRA patients who are poor metabolizers.

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. Monitor patients for signs and symptoms of gastrointestinal ulceration and/or hemorrhage. Monitor serum electrolytes, renal function and urinalysis after significant overdose.

3 years.

The expiration date refers to the product correctly stored in the required conditions.

Do not store above 30°C.

Protect from sunlight and moisture.

COXIGET Capsules 200 mg are available in Alu-Alu blister packs of 2x10's capsules in a unit carton along with the package insert.

COXIGET Capsules 400 mg are available in Alu-Alu blister packs of 2x10's capsules in a unit carton along with the package insert.

Keep out of reach of children.

To be sold on prescription of a registered medical practitioner only.