Usual Adult Dose for Osteoarthritis

40 drops topically per knee 4 times a day

Comments:

• Use the lowest effective dose for the shortest duration consistent with treatment goals; application in an amount exceeding or less than the recommended dose has not been studied and is therefore, not recommended.
• To avoid spillage dispense 10 drops at a time directly onto knee or into hand then onto knee; repeat until all drops have been applied.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

• Nonsteroidal anti-inflammatory drugs (NSAIDs) 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.
• 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 greater risk for serious GI events.

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to active substance or any 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
• In the setting of coronary artery bypass graft (CABG) surgery

Dialysis

Data not available

Other Comments

Administration advice:

• Apply to clean, dry skin
• To avoid spillage, dispense 10 drops at a time either directly onto the knee or first into the hand and then onto knee; spread topical solution evenly around front, back, and sides of the knee
• Repeat procedure until entire dose (40 drops) has been applied and the knee is completely covered with solution; treat other knee if symptomatic
• Wash hands after applying solution
• Avoid showering/bathing for 30 minutes after application
• Do not apply solution to open wounds
• Avoid contact with eyes and mucous membranes; if eye contact occurs, immediately wash out eye with water or saline and consult a physician if irritation persists for than 1 hour
• Do not apply external heat and/or occlusive dressings to treated knees
• Avoid wearing clothing over the application site until the treated area has dried
• Protect treated knee(s) from natural or artificial sunlight
• If applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to knee, wait until the treated area is dry
• Avoid skin to skin contact with other people until the knee(s) is completely dry

• Combination with other NSAIDs should be avoided unless the benefit outweighs the risk; if used, laboratory monitoring should be performed periodically.

• 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 instructed to read the US FDA-approved patient labeling (Medication Guide).
• 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.