Sulindac (Sulindac) - Indications and Dosage

INDICATIONS AND USAGE

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

Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following:

1. Osteoarthritis

2. Rheumatoid arthritisThe safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care).

3. Ankylosing spondylitis

4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)

5. Acute gouty arthritis

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. 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 sulindac, the dose and frequency should be adjusted to suit an individual patient's needs.

Sulindac should be administered orally twice a day with food. The maximum dosage is 400 mg per day. Dosages above 400 mg per day are not recommended.

In osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, the recommended starting dosage is 150 mg twice a day. The dosage may be lowered or raised depending on the response.

A prompt response (within one week) can be expected in about one-half of patients with osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis. Others may require longer to respond.

In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. After a satisfactory response has been achieved, the dosage may be reduced according to the response. In acute painful shoulder, therapy for 7-14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate.

HOW SUPPLIED

Sulindac Tablets USP are supplied as follows:

Sulindac tablets, 150 mg, yellow, round, unscored, debossed MP 112

Bottles of 50                                                  NDC 53489-478-02
Bottles of 60                                                  NDC 53489-478-06
Bottles of 100                                                NDC 53489-478-01
Bottles of 250                                                NDC 53489-478-03
Bottles of 500                                                NDC 53489-478-05
Bottles of 1000                                              NDC 53489-478-10

Sulindac tablets, 200 mg, yellow, round, scored, debossed MP 116

Bottles of 50                                                  NDC 53489-479-02
Bottles of 60                                                  NDC 53489-479-06
Bottles of 100                                                NDC 53489-479-01
Bottles of 250                                                NDC 53489-479-03
Bottles of 500                                                NDC 53489-479-05
Bottles of 1000                                              NDC 53489-479-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev: February 2006Ch