Acella Hydrocortisone Acetate - Pramoxine Singles

Name: Acella Hydrocortisone Acetate - Pramoxine Singles

Usual Adult Dose for Psoriasis

Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: Apply a thin film to the affected area 3 to 4 times a day, depending on severity of condition.

Comments:
-Should only be used externally
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; should discontinue use of occlusive dressings if an infection develops.
-For cleansing the anogenital area, the rectal lotion should be applied with a tissue or cotton ball.
-If redness, pain, irritation, or swelling persists, the topical foam should be discontinued; not for prolonged use.

Rectal foam: Apply to affected area 3 to 4 times a day.

Comments:
-The applicator supplied should be used for anal administration.
-For perianal use, a small amount should be transferred to a tissue and gently rubbed in.
-If no clinical improvement within 2 or 3 weeks after starting therapy, or if patient's condition worsens, the rectal foam should be discontinued.

Approved indications:
-Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
-Rectal foam: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region

Usual Pediatric Dose for Dermatitis

Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: Apply a thin film to the affected area 3 to 4 times a day, depending on severity of condition.

Comments:
-Should only be used externally
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; should discontinue use of occlusive dressings if an infection develops.
-For cleansing the anogenital area, the rectal lotion should be applied with a tissue or cotton ball.
-If redness, pain, irritation, or swelling persists, the topical foam should be discontinued; not for prolonged use.

Rectal foam: Apply to affected area 3 to 4 times a day.

Comments:
-The applicator supplied should be used for anal administration.
-For perianal use, a small amount should be transferred to a tissue and gently rubbed in.
-If no clinical improvement within 2 or 3 weeks after starting therapy, or if patient's condition worsens, the rectal foam should be discontinued.

Approved indications:
-Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
-Rectal foam: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region

Usual Pediatric Dose for Psoriasis

Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: Apply a thin film to the affected area 3 to 4 times a day, depending on severity of condition.

Comments:
-Should only be used externally
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions; should discontinue use of occlusive dressings if an infection develops.
-For cleansing the anogenital area, the rectal lotion should be applied with a tissue or cotton ball.
-If redness, pain, irritation, or swelling persists, the topical foam should be discontinued; not for prolonged use.

Rectal foam: Apply to affected area 3 to 4 times a day.

Comments:
-The applicator supplied should be used for anal administration.
-For perianal use, a small amount should be transferred to a tissue and gently rubbed in.
-If no clinical improvement within 2 or 3 weeks after starting therapy, or if patient's condition worsens, the rectal foam should be discontinued.

Approved indications:
-Rectal cream, rectal lotion, topical cream, topical foam, topical lotion: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
-Rectal foam: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region

Renal Dose Adjustments

Data not available

Other Comments

Administration advice:
-Avoid contact with eyes.
-Do not use under occlusive dressings or diapers without physician supervision.
-Rectal foam, rectal lotion, topical foam, topical lotion: Shake well before each use.
-Rectal foam: Do not insert any part of the aerosol container directly into the anus.
-Topical foam: Do not insert the aerosol container into the vagina or anus.
-Rectal foam, topical foam: Consult the manufacturer's product information for administration instructions.

Storage requirements:
-Rectal foam, topical foam: Aerosol container should not be stored at temperatures above 49C (120F); should store upright at controlled room temperature 20C to 25C (68F to 77F); should not refrigerate.

General:
-Not recommended for prolonged use.

Monitoring:
-Endocrine: Urinary free cortisol and ACTH stimulation tests

Hydrocortisone / pramoxine topical Breastfeeding Warnings

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a harmful effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

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