Usual Adult Dose for Actinic Keratosis

3% Topical Gel:

• Apply a sufficient amount to cover each lesion twice a day; rub in gently
• Duration of therapy: 60 to 90 days

Comments:

• Complete healing of lesions may not be evident for up to 30 days following cessation of therapy.
• Lesions not responding to therapy should be carefully reevaluated and management reconsidered.

Use: For the topical treatment of actinic keratosis

Usual Adult Dose for Osteoarthritis

1% Topical Gel:
Lower Extremities including feet, ankles, or knees:

• Apply 4 g topically to the entire affected foot, knee, or ankle 4 times a day and rub in gently; the entire foot includes the sole, top of foot, and toes

Upper Extremities including hands, wrists, or elbow:

• Apply 2 g topically to the entire affected hand, wrist, or elbow 4 times a day and rub in gently; the entire hand includes the palm, back of hands, and fingers

Maximum dose: 32 g/day over all affected joints

• Do not exceed 8 g/day to any single joint of the upper extremities or 16 g/day to any single joint of the lower extremities

1.5% Topical Solution:

• Apply 40 drops topically to each affected knee 4 times a day; spread evenly around front, back, and sides of knee(s)

2% Topical Solution:

• Apply 40 mg (2 pump actuations) topically to each affected knee 2 times a day; dispense directly into palm of hand then apply evenly around front, back, and sides of knee(s)

Comments:

• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• The topical gel has not been evaluated for use on the spine, hip, or shoulder; the topical solution is only for use on the knees.
• Consult other comments/administration advice for specifics on administration.

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

Usual Adult Dose for Pain

1.3% Topical System:

• Apply 1 topical system to the most painful area twice a day

Comments:

• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Consult other comments/administration advice for specifics on administration.

Use: For the topical treatment of acute pain due to minor strains, sprains, and contusions.

Usual Pediatric Dose for Pain

1.3% Topical System:

6 years or older:

• Apply 1 topical system to the most painful area twice a day

Comments:

• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Consult other comments/administration advice for specifics on administration.

Use: For the topical treatment of acute pain due to minor strains, sprains, and contusions.

Renal Dose Adjustments

Advanced renal disease: Avoid use unless benefit is expected to outweigh risk of worsening renal function

Liver Dose Adjustments

Discontinue if liver disease develops, if abnormal liver tests persist or worsen, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.)

Dose Adjustments

Elderly patients may require lower doses due to increased risk for adverse effects and increased likelihood of concomitant cardiovascular, gastrointestinal, hepatic and/or renal dysfunctions.

• Systemic diclofenac meets the American Geriatrics Society Beers list criteria as a medication that is potentially inappropriate for use in the elderly.

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.
• NSAIDs are 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 of topical system have not been established in patients younger than 6 years.
Safety and efficacy of topical gel and topical solution have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
For Topical Administration Only

• Avoid contact with eyes and mucous membranes
• If eye contact occurs, immediately wash out eye with water or saline; consult a physician if irritation persists for more than 1 hour
• Do not apply to open wounds, skin infections, or peeling skin
• Limit exposure to natural or artificial sunlight (e.g., tanning beds and sunlamps) as skin may be more sensitive during therapy
• Do not apply heat and/or occlusive dressings over application sites
• Avoid concomitant use of other topical products (e.g., sunscreen, lotions, insect repellant) on treated site

1% Topical Gel:

• Dosing card (supplied in drug product carton) should be used for each application
• Squeeze gel onto dosing card evenly to the dosing line
• Apply gel using the dosing card, then use hands to gently rub gel into skin
• If treatment site is the hands, wait at least 1 hour to wash hands, otherwise wash hands after use
• Wait 10 minutes after application before covering treated skin with gloves or clothing
• Do not shower or bathe for at least 1 hour after applying
• Rinse dosing card, dry, and store for next use; do not share dosing card; if dosing card is lost, contact pharmacist for a replacement

3% Topical Gel:

• Apply enough gel to adequately cover each lesion; rub gently
• Wash hands after applying

1.5% Topical Solution:

• Apply to clean, dry skin; wash hands before and after applying
• To avoid spillage, apply 10 drops at a time either directly to knee(s) or place in hand then rubbed onto knee(s), repeat until all 40 drops have been applied and the knee is completely covered
• Avoid wearing clothing over application site until knee(s) is dry; avoid skin-to-skin contact between other people until knee(s) is completely dry
• Avoid showering/bathing for at least 30 minutes following application
• Do not apply sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to knee(s) until application site is completely dry

2% Topical Solutions:

• Apply to clean, dry skin; wash hands before and after applying
• Pump must be primed prior to first use; once primed no further priming is needed
• To prime, fully depress pump mechanism 4 times while holding bottle in upright position; discard expelled product
• Once primed, depress pump 2 times directly into palm of hand and then apply evenly around front, back, and sides of knee; repeat as needed for other knee
• Avoid wearing clothing over application site until knee(s) is dry; avoid skin-to-skin contact between other people until knee(s) is completely dry
• Avoid showering/bathing for at least 30 minutes following application
• Do not apply sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to knee(s) until application site is completely dry

1.3% Topical System

• Instruct patients to read the directions for use on the product packaging
• Topical system is supplied in resealable envelopes; keep envelopes sealed when not in use
• Apply to most painful area twice a day
• If patch begins to peel off, the edges may be secured with tape or with a mesh netting sleeve that is not occlusive
• Do not wear when bathing/showering
• Wash hands after applying, handling, or removing topical system

Storage Requirements:

• Gel (1%): Protect from freezing; store with dosing card
• Gel (3%): Protect from heat; avoid freezing
• Topical system (1.3%): Keep sealed in resealable envelopes when not in use

General:

• Use the lowest effective dose for the shortest duration consistent with individual patient 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.
• Avoid concomitant use with other NSAIDs.

Monitoring:

• Cardiovascular: Monitor blood pressure during initiation and periodically thereafter
• 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; obtain renal function tests periodically during long-term therapy
• Liver function: Monitor baseline transaminases and repeat periodically during long-term therapy
• Monitor blood counts periodically during long-term therapy

Patient Advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should understand that cardiovascular thrombotic events, gastrointestinal events, skin reactions, allergic reactions, hepatotoxicity, or edema may occur; they should be instructed when and where to seek medical advice should these occur.
• Patients should be instructed to talk with their healthcare provider regarding concomitant use of NSAIDs (including over the counter products) and aspirin while using this product.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug is not recommended for use during pregnancy or lactation.
• Patients should be instructed to avoid contact with eyes and mucosa; if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.