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

Lodine (etodolac capsules and tablets) is indicated:

• For acute and long-term use in the management of signs and symptoms of the following:

1. Osteoarthritis
2. Rheumatoid arthritis

• For the management of acute pain

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

Dosage adjustment of Lodine is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).

Analgesia

The recommended total daily dose of Lodine for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

Osteoarthritis and Rheumatoid Arthritis

The recommended starting dose of Lodine for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

In chronic conditions, a therapeutic response to therapy with Lodine is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Lodine (etodolac capsules and tablets) is available as:

Lodine® (etodolac capsules) Capsules

200 mg capsules (light gray with one wide red band with LODINE 200/white with two narrow red bands)

—in bottles of 100, NDC 0046-0738-81

300 mg capsules (light gray with one wide red band with LODINE 300/light gray with two narrow red bands)

—in bottles of 100, NDC 0046-0739-81

Store at controlled room temperature 20°-25°C (68°-77°F), protected from moisture.

Lodine® (etodolac tablets) Tablets

400 mg tablets (yellow-orange, oval, film-coated tablet, debossed LODINE 400 on one side)

—in bottles of 100, NDC 0046-0761-81

Store at controlled room temperature 20°-25°C (68°-77°F). Store tablets in original container until ready to use. Dispense in light-resistant container.

500 mg tablets (blue, oval, film-coated tablet, branded LODINE 500 on one side)

—in bottles of 100, NDC 0046-0787-81

Store at controlled room temperature 20°-25°C (68°-77°F).

Store tablets in original container until ready to use.

Dispense in a light-resistant container.

The appearance of these capsules is a registered trademark of Wyeth Pharmaceuticals and the appearance of these tablets is a trademark of Wyeth Pharmaceuticals.

Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 07/05. FDA Rev date: 1/18/2006

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