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CELEBREX (celecoxib) Dosage And Administration

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Dosage And Administration

Dosing Considerations

Cardiovascular disease or cardiovascular risk factors: Treatment with CELEBREX, particularly at doses higher than 200 mg per day, should not be used in patients with pre-existing cardiovascular disease (congestive heart failure (NYHA II-IV), ischemic heart disease), cerebrovascular disease, or patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) (see WARNINGS AND PRECAUTIONS – Serious Warnings and Precautions).

Hepatic Impairment: CELEBREX capsules should be introduced at the lowest dose in patients with mild hepatic impairment (Child-Pugh 5-6). The daily recommended dose of CELEBREX capsules in patients with moderate hepatic impairment (Child-Pugh 7-9) should be reduced by 50% and should be given at the lowest dose of 100 mg once daily (see ACTION AND CLINICAL PHARMACOLOGY - Special Populations and Conditions). CELEBREX is contraindicated in patients with severe hepatic impairment (Child-Pugh >9) (see CONTRAINDICATIONS).

Renal Insufficiency: No dosage adjustment is necessary for patients with creatinine clearance >30 mL/min (see ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions). CELEBREX is contra-indicated in patients with severe renal impairment (estimated creatinine clearance <30 mL/min) (see CONTRAINDICATIONS).

Elderly (>65 years of age): In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary (see WARNINGS AND PRECAUTIONS – Special Populations – Geriatrics).

CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Celecoxib should be introduced at half the lowest recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see DRUG INTERACTIONS and WARNINGS AND PRECAUTIONS – Special Populations).

Recommended Dose and Dosage Adjustment – 18 years of age and older
Use of CELEBREX should be limited to the lowest effective dose for the shortest possible duration of treatment (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).

Osteoarthritis: The recommended daily dose of CELEBREX (celecoxib) is 200 mg administered as a single dose or as two divided doses (100 mg twice per day). Maximum dose = 200 mg a day.

Rheumatoid Arthritis: The recommended starting dose of CELEBREX is 100 mg twice per day, which may be increased to 200 mg twice per day if necessary. Maximum dose = 200 mg twice a day.

Ankylosing Spondylitis: The recommended daily dose of CELEBREX (celecoxib) is 200 mg administered as a single dose or as two divided doses (100 mg twice a day). Maximum dose = 200 mg a day.

Management of Acute Pain: The recommended dose of CELEBREX is 400 mg as a single dose on the first day followed by 200 mg once daily on subsequent days up to a maximum of 7 days. Patients may be instructed to take an additional dose of 200 mg on any given day, if needed. Maximum dose = 400 mg a day for up to 7 days.

Administration

CELEBREX can be taken with or without food.

Missed Dose

Patients who miss one or more doses of CELEBREX (celecoxib) should not increase the dose of CELEBREX to compensate for the missed dose or doses, but should continue therapy as soon as possible, then take the next dose at the scheduled time.

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