Usual Adult Dose for Osteoarthritis

Loading dose: 1200 mg to 1800 mg orally; not to exceed 26 mg/kg
Maintenance dose: 1200 mg orally once a day
Maximum dose: 1800 mg or 26 mg/kg orally per day, whichever is less, in divided doses

Comments:

• A one-time loading dose may be given if quick onset of action is needed.
• Doses larger than 1200 mg orally per day on a chronic basis are reserved for patients weighing more than 50 kg, with normal renal and hepatic function, at low risk for peptic ulcer, and whose disease severity justifies maximal therapy.
• 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.

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

Usual Adult Dose for Rheumatoid Arthritis

Loading dose: 1200 mg to 1800 mg orally; not to exceed 26 mg/kg
Maintenance dose: 1200 mg orally once a day
Maximum dose: 1800 mg or 26 mg/kg orally per day, whichever is less, in divided doses

Comments:

• A one-time loading dose may be given if quick onset of action is needed.
• Doses larger than 1200 mg orally per day on a chronic basis are reserved for patients weighing more than 50 kg, with normal renal and hepatic function, at low risk for peptic ulcer, and whose disease severity justifies maximal therapy.
• 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.

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

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

6 to 16 years:

22 to 31 kg: 600 mg orally once a day
32 to 54 kg: 900 mg orally once a day
55 kg or greater: 1200 mg orally once a day
Maximum dose: 1200 mg orally per 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

Usual Pediatric Dose for Osteoarthritis

17 to 18 years:
1200 mg orally once a day
Maximum dose: 1200 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.

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

Usual Pediatric Dose for Rheumatoid Arthritis

17 to 18 years:
1200 mg orally once a day
Maximum dose: 1200 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.

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

Renal Dose Adjustments

Severe renal dysfunction (CrCl less than 30 mL/min):

• Initial dose: 600 mg orally once a day
• Maintenance dose: May increase cautiously to 1200 mg with close monitoring if insufficient relief of symptoms

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.

Dose Adjustments

Less than 50 kg:

• Initial dose: 600 mg orally once a day
• Maintenance dose: May increase cautiously to 1200 mg with close monitoring if insufficient relief of symptoms

• Doses larger than 1200 mg orally per day on a chronic basis are reserved for patients weighing more than 50 kg, with normal renal and hepatic function, at low risk for peptic ulcer, and whose disease severity justifies maximal therapy.

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 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

• Initial dose: 600 mg orally once a day
• Maintenance dose: May increase cautiously to 1200 mg with close monitoring if insufficient relief of symptoms.

Other Comments

Administration advice:

• Take orally once a day; doses may be divided in patients unable to tolerate single doses.

Storage requirements:

• Protect from light.
• Store at 25C (77F).

General:

• Doses should be individualized to the lowest effective dose for the shortest duration possible to minimize adverse effects.
• Physicians should ensure that patients tolerate doses of 600 mg to 1200 mg orally per day without gastroenterologic, renal, hepatic, or dermatologic adverse effects prior to increasing the dose.
• 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.