Usual Adult Dose for Rheumatoid Arthritis

Recommended dose: 20 mg orally once a day

Comments:

• The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
• Due to the long half-life, there is a progressive response to treatment over several weeks; the effect of therapy should not be assessed for 2 weeks.

Usual Adult Dose for Osteoarthritis

Recommended dose: 20 mg orally once a day

Comments:

• The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
• Due to the long half-life, there is a progressive response to treatment over several weeks; the effect of therapy should not be assessed for 2 weeks.

Renal Dose Adjustments

Mild to Moderate Renal Dysfunction: No adjustment recommended
Advanced Renal Disease: Not recommended

If treatment is necessary in patients with renal impairment, close monitoring of renal function is advised.

Liver Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested.

• 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

• This drug should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize side effects.

• CYP450 2C9 poor metabolizers: This drug should be used with caution in individuals with genetic polymorphisms in the CYP450 2C9 enzyme due to reduced metabolic clearance and consequently the risk for increased systemic exposure.

• Elderly: Consider starting at the low end of the dosing range due to the increased risk for adverse effects.

Precautions

US BOXED WARNINGS: CARDIOVASCULAR RISK AND GASTROINTESTINAL RISK:

• 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 and in patients with CV disease or risk factors for CV disease.
• This drug is contraindicated for the treatment of per-operative 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.

Dialysis

Data not available

Other Comments

Administration advice:

• May take orally once a day or in divided doses twice a day

• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• 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 or risk factors for cardiovascular disease, and higher doses.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Due to the increased risk for gastrointestinal (GI) complications, the need for combination therapy with a gastroprotective agent should be considered, especially for elderly patients.

• Blood pressure should be monitored closely during initiation and throughout course of therapy.
• Monitor for signs/symptoms of gastrointestinal bleeding.
• 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.

• 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.
• 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 shortness of breath, slurred speech, chest pain, or weakness on one side of the body occurs.
• 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.