Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 400 mg orally 3 times a day
Maintenance dose: 600 to 1800 mg orally in 3 divided doses
Maximum dose: 1800 mg orally per day

Comments:

• It is recommended to include a dose upon awaking and a dose at bedtime.
• Doses should be adjusted according to response to treatment after 1 or 2 weeks.
• 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 rheumatoid arthritis, including acute flares and long term management of chronic disease.

Usual Adult Dose for Osteoarthritis

Initial dose: 400 mg orally 3 times a day
Maintenance dose: 600 to 1800 mg orally in 3 divided doses
Maximum dose: 1800 mg orally per day

Comments:

• It is recommended to include a dose upon awaking and a dose at bedtime.
• Doses should be adjusted according to response to treatment after 1 or 2 weeks.
• 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, including acute flares and long term management of chronic disease.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

2 years or older:
Initial dose: 20 mg/kg/day orally in 3 to 4 divided doses
Maintenance dose: 15 to 30 mg/kg/day orally in 3 to 4 divided doses
Maximum dose: 30 mg/kg/day

Comments:

• 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 juvenile rheumatoid arthritis, including acute flares and long term management of chronic disease.

Renal Dose Adjustments

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.

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 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally 3 times a day, preferably including a dose upon awaking and a dose at bedtime.
• If gastrointestinal symptoms occur, administer with antacids other than sodium bicarbonate.

Storage requirements:

• Protect from light.

General:

• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Therapeutic response is expected in a few days to a week of beginning treatment; progressive improvement can be expected in succeeding weeks.

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 cardiovascular events, 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.
• Patients should be aware that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications.
• Advise patients not to engage in activities requiring mental alertness or motor coordination, including driving, until the effects of this drug are realized.