Acella Hydrocortisone Acetate - Pramoxine Singles

Name: Acella Hydrocortisone Acetate - Pramoxine Singles

For the Consumer

Applies to hydrocortisone / pramoxine topical: external cream, external foam, external gel, external lotion, external ointment

Other dosage forms:

  • rectal cream, rectal foam, rectal kit, rectal lotion

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry skin.
  • Burning.
  • Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to hydrocortisone / pramoxine topical: rectal cream, rectal foam, rectal kit, rectal lotion, topical cream, topical foam, topical gel, topical lotion, topical ointment

Dermatologic

Dermatologic side effects including burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including allergic contact dermatitis have been reported.[Ref]

Some side effects of hydrocortisone / pramoxine topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Hemorrhoids

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

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

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