Usual Adult Dose for Osteoarthritis

Oral Tablets and Oral Disintegrating Tablets:

• Initial dose: 7.5 mg orally once a day
• Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
• Maximum dose: 15 mg orally once a day

Oral Capsules:

• Initial dose: 5 mg orally once a day
• Maintenance dose: 10 mg orally once a day in patients requiring additional analgesia
• Maximum dose: 10 mg orally once a day

Comments:

• Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable.
• The lowest effective dose for the shortest duration possible consistent with individual treatment goals should be used.

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

Usual Adult Dose for Rheumatoid Arthritis

Oral Tablets and Oral Disintegrating Tablets:

• Initial dose: 7.5 mg orally once a day
• Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
• Maximum dose: 15 mg orally once a day

Comments:

• Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable.
• The lowest effective dose for the shortest duration possible consistent with individual treatment goals should be used.

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

Usual Adult Dose for Pain

30 mg IV bolus (over 15 seconds) once a day

Comments:

• Median time to meaningful pain relief was 2 to 3 hours in clinical trials; a non-NSAID with a rapid onset may be needed; some patients may not experience adequate analgesia for the first 24-hours.
• The lowest effective dose for the shortest duration possible consistent with individual treatment goals should be used.

Use: For the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

2 years or older:

Oral Tablets and Oral Disintegrating Tablets:
Weight: 60 kg or greater: 7.5 mg orally once a day

• No additional benefit has been demonstrated with doses above 7.5 mg/day.

Comments:

• Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable
• The oral tablets should not be used in children who weigh less than 60 kg.

Use: For the relief of signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis

Renal Dose Adjustments

Oral:

• Mild to moderate renal dysfunction: No adjustment recommended
• Severe renal dysfunction: Not recommended

Parenteral:

• Mild renal impairment: No adjustment recommended
• Moderate to severe renal impairment in patients at risk for renal failure due to volume depletion: Contraindicated
• Moderate to severe renal impairment: Not recommended

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Use with caution; monitor for adverse effects

Dose Adjustments

Elderly: Due to risk for NSAID-associated serious adverse reactions, benefits and risks should be carefully weighed before initiating therapy

Poor Metabolizers of CYP450 2C9 Substrates:

• Dose reduction should be considered as these patients may have elevated plasma levels due to reduced clearance

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, 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.
• 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.

CONTRAINDICATIONS:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to the active component or any of the ingredients
• History of asthma, urticaria, nasal polyps, or allergic-type reactions after taking aspirin or other NSAIDs
• In the setting of coronary artery bypass graft (CABG) surgery
• Patients with moderate to severe renal insufficiency at risk for renal failure due to volume depletion (injectable)
• Patients with phenylketonuria (oral disintegrating tablets)

Oral Tablets and Oral Disintegrating Tablets:

• Safety and efficacy have been established in pediatric patients 2 to 17 years with juvenile arthritis, however, use is not recommended in patients weighing less than 60 kg.

Oral Capsules and Parenteral Injection:

• Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:

• Oral Tablets and Oral Disintegrating Tablets: Maximum dose: 7.5 mg orally once a day
• Oral Capsules: Maximum dose: 5 mg orally once a day

Other Comments

Administration advice:
Tablets or Capsules:

• Take orally once a day with or without food

Oral Disintegrating Tablets:

• Take orally once a day with or without food
• Do not remove tablet from blister pack until just prior to dosing
• Peel blister pack open with clean, dry hands; remove tablet and place on tongue; liquid is not necessary

Parenteral Injection:

• For IV administration only
• Administer by IV bolus over 15 seconds
• To reduce risk of toxicity, patients should be well-hydrated prior to administration

Storage:
Parenteral Injection: Store at 15C to 25C (59F to 77F); do not freeze; protect from light

General:

• Oral formulations are not interchangeable with each other and should therefore, not be substituted.
• Undesirable side effects may be minimized by using the lowest effective dose for the shortest duration possible.
• Following initial response to therapy, the dose should be adjusted to suit individual patient needs.
• 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.

Monitoring:

• Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
• Gastrointestinal: Assess 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 be instructed to read the US FDA-approved patient labeling (Medication Guide for NSAIDs).
• Patients should seek medical advice for signs and symptoms of 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.

Frequently asked questions

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