Usual Adult Dose for Acute Gout

Initial dose: 200 mg orally twice a day
Maximum dose: 400 mg orally per day
Duration of therapy: 7 days is usually adequate

Comment:

• 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: Use: For the relief of signs and symptoms of acute gouty arthritis

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 150 mg orally twice a day
Maximum dose: 400 mg orally per day

Comment:

• 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, rheumatoid arthritis, and ankylosing spondylitis

Usual Adult Dose for Osteoarthritis

Initial dose: 150 mg orally twice a day
Maximum dose: 400 mg orally per day

Comment:

• 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, rheumatoid arthritis, and ankylosing spondylitis

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 150 mg orally twice a day
Maximum dose: 400 mg orally per day

Comment:

• 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, rheumatoid arthritis, and ankylosing spondylitis

Usual Adult Dose for Bursitis

Initial dose: 200 mg orally twice a day
Maximum dose: 400 mg orally per day
Duration of therapy: 7 to 14 days is usually adequate

Comment:

• 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 acute painful shoulder, including acute subacromial bursitis and supraspinatus tendinitis.

Usual Adult Dose for Tendonitis

Initial dose: 200 mg orally twice a day
Maximum dose: 400 mg orally per day
Duration of therapy: 7 to 14 days is usually adequate

Comment:

• 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 acute painful shoulder, including acute subacromial bursitis and supraspinatus tendinitis.

Renal Dose Adjustments

• Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function and a lower daily dose is advised.

Liver Dose Adjustments

• Use caution; lower daily doses may be required in patients with acute or chronic hepatic disease.
• 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 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:

• Take twice a day with food.

General:

• Response to therapy can usually be seen within 1 week of beginning treatment in half of patients with osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis; others may take longer to respond.
• 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.
• 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, 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.