Usual Adult Dose for Pain

50 mg orally every 4 to 6 hours; doses of 100 mg may be needed in certain patients
Maximum dose: 400 mg/day

Use: For the relief of mild to moderate pain

Usual Adult Dose for Dysmenorrhea

100 mg orally 3 times a day, beginning at onset of menstrual flow
Duration of therapy: Up to 6 days

Use: For the treatment of primary dysmenorrhea

Usual Adult Dose for Osteoarthritis

200 mg to 400 mg orally per day in 3 to 4 divided doses
Maximum dose: 400 mg/day

Comments:

• Initiate therapy at a lower dose and increase as necessary to improve clinical response.
• Dosages should be individualized for each patient based on the severity of symptoms and clinical response.
• Improvement may be seen within a few days of beginning therapy, however, 2 to 3 weeks of treatment may be needed to obtain optimum therapeutic benefit.

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

Usual Adult Dose for Rheumatoid Arthritis

200 mg to 400 mg orally per day in 3 to 4 divided doses
Maximum dose: 400 mg/day

Comments:

• Initiate therapy at a lower dose and increase as necessary to improve clinical response.
• Dosages should be individualized for each patient based on the severity of symptoms and clinical response.
• Improvement may be seen within a few days of beginning therapy, however, 2 to 3 weeks of treatment may be needed to obtain optimum therapeutic benefit.

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

Usual Pediatric Dose for Dysmenorrhea

14 years or older: 100 mg orally 3 times a day, beginning at onset of menstrual flow

• Duration of therapy: Up to 6 days

Use: For the treatment of primary dysmenorrhea

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

14 years or older: 200 mg to 400 mg orally per day in 3 to 4 equally divided doses

• Maximum dose: 400 mg/day

Comments:

• Initiate therapy at a lower dose and increase as necessary to improve clinical response.
• Dosages should be individualized for each patient based on the severity of symptoms and clinical response.
• Improvement may be seen within a few days of beginning therapy, however, 2 to 3 weeks of treatment may be needed to obtain optimum therapeutic benefit.

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

Renal Dose Adjustments

• Renal dysfunction: Use with caution.
• Advanced renal disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

Liver Dose Adjustments

• Liver dysfunction: Use with caution.
• 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.

Safety and efficacy have not been established in patients younger than 14 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take with food or milk if gastrointestinal upset occurs

Storage requirements:

• Protect from light and moisture.

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, 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.