Usual Adult Dose for Osteoarthritis

Immediate Release:

• Initial dose: 300 mg orally 2 to 3 times a day or 400 mg to 500 mg orally twice a day
• Maintenance dose: A lower dose of 600 mg/day may suffice for long-term use
• Maximum dose: 1000 mg/day

Extended Release: 400 mg to 1000 mg orally once a day

Comments:

• Therapeutic response can be seen within 1 week of therapy, however, is most often observed by 2 weeks; doses should be adjusted accordingly after satisfactory response is achieved.

Uses: For acute and long-term use in the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Rheumatoid Arthritis

Immediate Release:

• Initial dose: 300 mg orally 2 to 3 times a day or 400 mg to 500 mg orally twice a day
• Maintenance dose: A lower dose of 600 mg/day may suffice for long-term use
• Maximum dose: 1000 mg/day

Extended Release: 400 mg to 1000 mg orally once a day

Comments:

• Therapeutic response can be seen within 1 week of therapy, however, is most often observed by 2 weeks; doses should be adjusted accordingly after satisfactory response is achieved.

Uses: For acute and long-term use in the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Pain

Immediate Release: 200 mg to 400 mg orally every 6 to 8 hours

• Maximum dose: 1000 mg/day

Use: For the management of acute pain

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Extended Release:
6 to 16 years:
20 to 30 kg: 400 mg orally once a day
31 to 45 kg: 600 mg orally once a day
40 to 60 kg: 480 mg orally once a day
Greater than 60 kg: 1000 mg orally once a day

17 to 18 years: 400 mg to 1000 mg orally once a day

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Advanced renal disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

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.

Dose Adjustments

Elderly patients may require lower doses due to increased risk for adverse effects and increased likelihood of concomitant hepatic and/or renal impairment.

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, 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.

Extended Release: Safety and efficacy have not been established in patients younger than 6 years.

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

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available

Other Comments

Storage requirements:

• Protect from excessive heat and humidity.
• Protect from light.

General:

• 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.
• 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.
• Hematologic: Measure CBC and chemistry profile periodically during long-term treatment.
• 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 function, 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.