Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

FELDENE is indicated:

• For relief of the signs and symptoms of osteoarthritis.
• For relief of the signs and symptoms of rheumatoid arthritis.

Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with FELDENE, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of FELDENE, steady-state blood levels are not reached for 7–12 days. Therefore, although the therapeutic effects of FELDENE are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.

FELDENE® Capsules for oral administration:

Bottles of 100: 10 mg (NDC 0069-3220-66) maroon and blue #322
Bottles of 100: 20 mg (NDC 0069-3230-66) maroon #323

Distributed by: Pfizer Labs, Division of Pfizer Inc, NT, NY 10017. Revised June January 20076.
FDA rev date: 7/5/2007

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