Health Professional Information

Hydrocortisone acetate 1%
Pramoxine hydrochloride 1%
Aerosol foam
 

• Therapeutic Classification
• Indications and Clinical Use
• Pharmacology of the Active Ingredients
• Dosage and Administration
• Contraindications
• Coverage

Therapeutic Classification

Proctofoam-HC is an anti-inflammatory and anti-pruritic and has emollient properties that aid soothing and lubricating the mucosa to make stool evacuation more comfortable.

Indications and Clinical Use

For the temporary relief of anorectal inflammation, pruritus, pain and swelling associated with hemorrhoids, proctitis, cryptitis, fissures, postoperative pain and pruritus ani.

Pharmacology of the Active Ingredients

Hydrocortisone acetate USP 1%: a topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. The anti-inflammatory action of hydrocortisone inhibits the inflammatory reaction to toxic or mechanical injury.

Pramoxine hydrochloride USP 1%: is a surface or local anesthetic, which is not chemically related to the "cain" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics. Pramoxine produces satisfactory surface anesthesia and is well tolerated on the skin and mucous membranes. It works by numbing the area that is treated.

Dosage and Administration

Shake the aerosol container before using. Insert 1 applicatorful into anus 2 or 3 times daily and after each bowel evacuation.

The foam may also be placed on a perianal pad and applied externally as required to relieve pain and itching.

One application contains 375 mg of mucoadhesive base containing 1% hydrocortisone acetate USP (3.75 mg/dose) and 1% pramoxine hydrochloride USP (3.75 mg/dose).

Contraindications

Proctofoam-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is contraindicated in patients with infection, abscess, extensive fistulas or sinus tracts, tuberculosis, varicella, vaccinia or acute herpes simplex. Proctofoam-HC is also contraindicated in the presence of fungal infection. Proctofoam-HC should not be used in patients with a sensitivity to any of the components.

Coverage

Proctofoam-HC is listed as a benefit on the following provincial government formulary drug plans: British Columbia, Alberta, New Brunswick, Nova Scotia, Newfoundland/Labrador and Yukon. It is also covered by the Non-Insured Health Benefits (NIHB) Program for First Nations and Inuit (Exception Centre), the Interim Federal Health (IFH) Program for refugees and by most private insurance plans.