Clinoril (Sulindac) - Indications and Dosage

INDICATIONS AND USAGE

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

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

1. Osteoarthritis
2. Rheumatoid arthritis [The safety and effectiveness of CLINORIL 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 CLINORIL and other treatment options before deciding to use CLINORIL. 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 CLINORIL, the dose and frequency should be adjusted to suit an individual patient's needs.

CLINORIL 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

No. 3360  - Tablets CLINORIL 150 mg are bright yellow, hexagon-shaped, compressed tablets, coded MSD 941 on one side and CLINORIL on the other. They are supplied as follows:

NDC 0006-0941-68 in bottles of 100.

No. 3353X  - Tablets CLINORIL 200 mg are bright yellow, hexagon-shaped, compressed tablets, one side full scored, the other side half scored and debossed MSD 942. They are supplied as follows:

NDC 0006-0942-68 in bottles of 100.

Storage

Store in a well-closed container at room temperature 15-30ºC (59-86ºF).

Rx Only

Manufactured for:

Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

By:

MERCK SHARP & DOHME Pty., Ltd.
South Granville, NSW, Australia 2142.

Issued February 2007

Printed in USA

9676104