Usual Adult Dose for Osteoarthritis

Immediate Release: 50 mg orally 4 times a day or 75 mg orally 3 times a day
Maximum dose: 300 mg/day

Extended Release: 200 mg orally once a day
Maximum dose: 200 mg/day

Comments:

• Lower doses should be initiated in small individuals and elderly or debilitated patients.
• Once response to initial therapy is observed, the dose and frequency should be adjusted to fit individual patient needs.
• When considering treatment with 300 mg/day, the clinical benefit should be sufficient to offset potential increased risks.

Uses: For the management of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Rheumatoid Arthritis

Immediate Release: 50 mg orally 4 times a day or 75 mg orally 3 times a day
Maximum dose: 300 mg/day

Extended Release: 200 mg orally once a day
Maximum dose: 200 mg/day

Comments:

• Lower doses should be initiated in small individuals and elderly or debilitated patients.
• Once response to initial therapy is observed, the dose and frequency should be adjusted to fit individual patient needs.
• When considering treatment with 300 mg/day, the clinical benefit should be sufficient to offset potential increased risks.

Uses: For the management of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Dysmenorrhea

Immediate Release: 25 mg to 50 mg orally every 6 to 8 hours as needed
Maximum dose: 300 mg/day

Comments:

• Extended release capsules are not recommended for the treatment of acute pain.
• A larger dose may be considered if the patient's response to a previous dose was less than satisfactory, however, doses above 75 mg have not shown to provide added analgesia.
• Lower doses should be initiated in small individuals and elderly or debilitated patients.
• Once response to initial therapy is observed, the dose and frequency should be adjusted to fit individual patient needs.
• When considering treatment with 300 mg/day, the clinical benefit should be sufficient to offset potential increased risks.

Uses: For the management of pain and for the treatment of primary dysmenorrhea

Usual Adult Dose for Pain

Immediate Release: 25 mg to 50 mg orally every 6 to 8 hours as needed
Maximum dose: 300 mg/day

Comments:

• Extended release capsules are not recommended for the treatment of acute pain.
• A larger dose may be considered if the patient's response to a previous dose was less than satisfactory, however, doses above 75 mg have not shown to provide added analgesia.
• Lower doses should be initiated in small individuals and elderly or debilitated patients.
• Once response to initial therapy is observed, the dose and frequency should be adjusted to fit individual patient needs.
• When considering treatment with 300 mg/day, the clinical benefit should be sufficient to offset potential increased risks.

Uses: For the management of pain and for the treatment of primary dysmenorrhea

Renal Dose Adjustments

Mild renal dysfunction: Maximum dose 150 mg/day
Moderate renal dysfunction: Data not available
Severe renal dysfunction (GFR less than 25 mL/min/1.73 m2) or end-stage renal impairment: Maximum dose 100 mg/day

Liver Dose Adjustments

Liver impairment and serum albumin concentration less than 3.5 g/dL: Maximum initial dose of 100 mg/day

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.
• Patients over 75 years should have their initial dose reduced and renal function monitored.

Metabolic Impairment:

• All patients with metabolic impairment, especially those with hypoalbuminemia and reduced renal function may have increased levels of free (biologically active) drug and should be closely monitored.
• The dose may be increased to the range recommended for the general population only after individual tolerance has been determined.

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 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take with food, milk, or antacids to minimize gastrointestinal adverse effects.

Storage requirements:

• Keep container tightly closed.
• Protect from light.
• Protect from excessive heat and humidity.

General:

• Concomitant use of the immediate release and extended release capsules is not recommended.
• 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.
• 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.