Usual Adult Dose for Atopic Dermatitis

Apply a thin layer to affected area four times a day
Duration of therapy: Up to 8 days

Comments:

• An interval of at least 3 to 4 hours should be left between applications.
• Safety and efficacy of use beyond 8 days has not been established; use beyond 8 days may result in higher systemic levels and increase the likelihood of contact dermatitis.
• Application to greater than 10% body surface area may increase the risk for drowsiness.

Uses: For the short term management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus

Usual Adult Dose for Dermatitis

Apply a thin layer to affected area four times a day
Duration of therapy: Up to 8 days

Comments:

• An interval of at least 3 to 4 hours should be left between applications.
• Safety and efficacy of use beyond 8 days has not been established; use beyond 8 days may result in higher systemic levels and increase the likelihood of contact dermatitis.
• Application to greater than 10% body surface area may increase the risk for drowsiness.

Uses: For the short term management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus

Usual Adult Dose for Eczema

Apply a thin layer to affected area four times a day
Duration of therapy: Up to 8 days

Comments:

• An interval of at least 3 to 4 hours should be left between applications.
• Safety and efficacy of use beyond 8 days has not been established; use beyond 8 days may result in higher systemic levels and increase the likelihood of contact dermatitis.
• Application to greater than 10% body surface area may increase the risk for drowsiness.

Uses: For the short term management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus

Usual Adult Dose for Lichen Simplex Chronicus

Apply a thin layer to affected area four times a day
Duration of therapy: Up to 8 days

Comments:

• An interval of at least 3 to 4 hours should be left between applications.
• Safety and efficacy of use beyond 8 days has not been established; use beyond 8 days may result in higher systemic levels and increase the likelihood of contact dermatitis.
• Application to greater than 10% body surface area may increase the risk for drowsiness.

Uses: For the short term management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus

Usual Adult Dose for Pruritus

Apply a thin layer to affected area four times a day
Duration of therapy: Up to 8 days

Comments:

• An interval of at least 3 to 4 hours should be left between applications.
• Safety and efficacy of use beyond 8 days has not been established; use beyond 8 days may result in higher systemic levels and increase the likelihood of contact dermatitis.
• Application to greater than 10% body surface area may increase the risk for drowsiness.

Uses: For the short term management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly: Lower doses should be considered. There may be an increased risk of drowsiness and over sedation reflective of the increased frequency of concurrent hepatic, renal, or cardiac impairment and increased likelihood of concomitant disease and concomitant drug therapy in the elderly. Systemic doxepin meets the American Geriatrics Society Beers list criteria as a medication that is potentially inappropriate for use in the elderly.

Precautions

Safety and efficacy 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 use only; not for ophthalmic, oral, or intravaginal use
• Avoid use of occlusive dressings

Storage requirements:

• Store at or below 27C (80F).

General:

• Clinical studies did not include a sufficient number of patients 65 years or older and it is therefore unknown if they respond differently than younger patients.
• If excessive drowsiness occurs, consider reducing frequency of applications, amount of cream applied, and/or percentage of body surface area treated, or discontinuing therapy.

Patient advice:

• Advise patients of the possibility of drowsiness and to not operate heavy machinery, including driving a motor vehicle while using this drug.