Usual Adult Dose for Acne

Recommended dose: Apply a thin layer to the entire affected area once a day at bedtime

Comments:

• Excessive amounts of the gel formulation will result in "pilling" or "caking," which prevents over-application.
• Warmth and/or stinging may occur after application.
• An apparent exacerbation of acne may occur during the first weeks of treatment, and should not be a reason to discontinue treatment.
• Patients with and without acne reported that the gel formulation was less irritating than the cream formulation.

Usual Adult Dose for Dermatoheliosis

Recommended dose: Apply a pea-sized amount to the entire affected area once a day at bedtime
Duration of therapy: 48 weeks (0.05% cream/emollient cream) and 52 weeks (0.02% cream)

Comments:

• Approximately 20 to 30 minutes prior to application, patients should wash their faces with a mild soap and pat the skin dry.
• Warmth and/or stinging may occur after application.
• Improvement in fine wrinkling may not be observed for up to 6 months.

Usual Pediatric Dose for Acne

12 years and older:

• Recommended dose: Apply a thin layer to the affected area once a day at bedtime

• Excessive amounts of the gel formulation will result in "pilling" or "caking," which prevents over-application.
• Warmth and/or stinging may occur after application.
• An apparent exacerbation of acne may occur during the first weeks of treatment, and should not be a reason to discontinue treatment.
• Patients with and without acne reported that the gel formulation was less irritating than the cream formulation.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Severe warmth or stinging on application: Use may be temporarily stopped or the frequency of application decreased until the patient is able to tolerate treatment.

Precautions

Safety and efficacy for most formulations in the treatment of acne have not been established in patients younger than 12 years. Consult with the manufacturer product information for more information.

Safety and efficacy for the palliation of fine lines and wrinkles have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for topical use only, and should be used with caution around mucous membranes.
• The gel formulation should be kept tightly closed when not in use.
• Cosmetics may be used during treatment, but the area should be thoroughly washed and dried before this drug is applied. The application of topical products should be separated by approximately 1 hour.

• The manufacturer product information should be consulted.

• Excessive application may increase the risk of skin irritation without improving efficacy. The gel formulation "pills" or "cakes" when excessive amounts are added to the skin, which may help patients to determine an appropriate amount to use.
• The 0.02% cream and 0.05% emollient cream formulations are not indicated to eliminate wrinkles, repair sun-damaged skin, reverse photoaging, and/or restore youthful/younger-looking skin.
• Safety and efficacy with the 0.05% emollient cream formulation have not been established in patients over 50 years of age and/or with moderate to heavy skin pigmentation; efficacy and safety of the 0.02% cream formulation have not been established in patients over 71 years of age.

• Excessive skin irritation
• Sunburns/increased photosensitivity

• Patients should be counseled on using appropriate sun protection while on therapy.
• Patients should be instructed to wash the affected area with a mild, non-medicated soap and pat the area dry before application. Patients should be told to avoid washing the area too frequently or scrubbing the skin too hard.
• Patients should be warned that benefits may not be seen for up to 8 weeks; initially, acne may look worse, but patients should not discontinue use during this time.
• Patients should be told to avoid contact with extremes in weather, other topical drugs, agents with strong drying effects, preparations with high alcohol concentrations, abrasive soaps, astringents, spices, and/or lime or lime peels to decrease the risk of skin irritation.
• Patients should be advised to speak to healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.