Usual Adult Dose for Osteoarthritis

400 mg to 600 mg orally 3 or 4 times a day

• Maximum dose: 3200 mg/day

• Dose adjustments should be made following initiation of therapy or during exacerbations of the disease.
• Patients with rheumatoid arthritis usually require larger doses than those with osteoarthritis; the lowest effective dose that yields acceptable control for either condition should be employed.

Usual Adult Dose for Rheumatoid Arthritis

400 mg to 600 mg orally 3 or 4 times a day

• Maximum dose: 3200 mg/day

• Dose adjustments should be made following initiation of therapy or during exacerbations of the disease.
• Patients with rheumatoid arthritis usually require larger doses than those with osteoarthritis; the lowest effective dose that yields acceptable control for either condition should be employed.

Usual Adult Dose for Pain

200 mg orally every 4 to 6 hours as needed

Use: For the relief of mild to moderate pain

Renal Dose Adjustments

Advanced renal disease: Avoid use unless benefit is expected to outweigh risk of worsening renal function

Liver Dose Adjustments

If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Dose Adjustments

Elderly: Elderly patients may require lower doses due to increased risk for adverse effects including cardiovascular, gastrointestinal, hepatic and/or renal adverse reactions.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Dialysis

Data not available

Other Comments

Administration advice:

• May take with meals or with milk; total amount absorbed is not affected, however, peak blood levels are delayed/diminished.

• Keep in tightly closed containers.

• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Improvement may be seen in a few days, however, an additional 2 to 3 weeks of treatment may be required to gauge full benefits of therapy.
• There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

• Cardiovascular: Monitor blood pressure during initiation and throughout the course of therapy.
• Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
• Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
• Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

• Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.