Usual Adult Dose for Pain

Initial dose: Day 1: 400 mg orally once followed by an additional 200 mg orally if needed
Maintenance dose: 200 mg orally twice a day as needed

Comment:

• Carefully consider benefits and risks.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.

Use: For the management of acute pain.

Usual Adult Dose for Dysmenorrhea

Initial dose: Day 1: 400 mg orally once followed by an additional 200 mg orally if needed
Maintenance dose: 200 mg orally twice a day as needed

Comment:

• Carefully consider benefits and risks.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.

Use: For the treatment of primary dysmenorrhea.

Usual Adult Dose for Osteoarthritis

200 mg orally once a day OR 100 mg orally twice a day

Comments:

• Carefully consider benefits and risks.
• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of osteoarthritis.

Usual Adult Dose for Rheumatoid Arthritis

100 or 200 mg orally twice a day

Comments:

• Carefully consider benefits and risks.
• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of rheumatoid arthritis.

Usual Adult Dose for Ankylosing Spondylitis

200 mg orally once a day OR 100 mg orally twice a day

• If no effect after 6 weeks, consider increasing daily dose to 400 mg daily

Maximum dose: 400 mg per day

Comments:

• Carefully consider benefits and risks.
• If no effect is observed after 6 weeks at 400 mg per day, alternative treatments should be considered as a response is not likely.
• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of ankylosing spondylitis.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Age: 2 years or older:

Weight: 10 kg to 25 kg: 50 mg orally twice a day
Weight: Greater than 25 kg: 100 mg orally twice a day

Comments:

• Carefully consider benefits and risks.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• For pediatric patients who are CYP450 2C9 poor metabolizers, consider alternative treatment.

Use: For the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years or older.

Renal Dose Adjustments

Mild to moderate renal impairment: No dose adjustment recommended
Severe renal impairment (CrCl less than 30 mL/min): Avoid the use of in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if used, monitor patients for signs of worsening renal function

Liver Dose Adjustments

Mild hepatic impairment: No dose adjustment recommended
Moderate hepatic impairment (Child-Pugh Class B): Reduce dose by 50%
Severe hepatic impairment: Use not recommended

Dose Adjustments

CYP450 2C9 Poor Metabolizers (known or suspected based on genotype or previous history or experiences with other CYP450 2C9 substrates):

• Adults: Consider initiating treatment at one-half the lowest recommended dose
• Pediatrics: Consider alternative treatment

Elderly: Weight greater than 50 kg: No dose adjustment recommended
Elderly, Weight less than 50 kg: Initiate therapy at the lowest recommended dose

Precautions

US BOXED WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

• Cardiovascular Thrombotic Events: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including 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.
• Gastrointestinal (GI) Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious 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 peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS:

• Known hypersensitivity to this drug (e.g., anaphylactic reactions and serious skin reaction), or any of the product excipients
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• Demonstrated allergic-type reactions to sulfonamides
• In the setting of coronary artery bypass graft (CABG) surgery

Safety and efficacy have not been established in patients younger than 18 years except for those 2 to 17 years with Juvenile Rheumatoid Arthritis in which safety and efficacy have been established for up to 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take with or without food

For Patients with Difficulty Swallowing Capsules:

• Carefully sprinkle the entire contents of the capsule onto a level teaspoon of cool or room temperature applesauce and ingest immediately with water.

Storage requirements:

• The sprinkled capsule contents on applesauce are stable for up to 6 hours when stored in the refrigerator [36F to 46F (2C to 8C)].

General:

• 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.
• This drug is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Monitoring:

• Blood pressure should be monitored closely during initiation and throughout course of therapy.
• Monitor for signs and symptoms of edema including worsening heart failure and cardiac ischemia
• Monitor for signs/symptoms of gastrointestinal bleeding
• Monitor for rash
• 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 be instructed to read the US FDA-approved patient labeling (Medication Guide for NSAIDs).
• 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 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 talk to their health care provider before they use over the counter analgesics.

Frequently asked questions

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