Usual Adult Dose for Osteoarthritis

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:

• Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
• Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:

• Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
• Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Renal Dose Adjustments

Mild renal dysfunction (CrCl 50 mL/min or greater): No adjustment recommended.

Moderate renal dysfunction (CrCl 30 to 49 mL/min):

• Initial dose: 750 mg orally once a day
• Maximum dose: 1500 mg/day

Severe renal dysfunction (CrCl less than 30 mL/min):

• Initial dose: 500 mg orally once a day
• Maximum dose: 1000 mg/day

Avoid use in patients with advanced renal impairment; if use is necessary, initiate with close monitoring of renal function.

Liver Dose Adjustments

• Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Precautions

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

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
• This drug is contraindicated for the treatment of perioperative pain 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 are at a greater risk for serious GI events.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May be taken orally with or without food once or twice a day.

Storage requirements:

• Dispense in light-resistant container.

General:

• The lowest effective dose for the shortest duration possible should be used.
• 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.

Monitoring:

• Cardiovascular: Monitor blood pressure closely during initiation and throughout 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.

Patient advice:

• 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.