Proctofoam – HC (Hydrocortisone Acetate – Pramoxine HCl)

PROCTOFOAM™-HC

R & C

Hydrocortisone Acetate – Pramoxine HCl

Anorectal Therapy

Action And Clinical Pharmacology: Proctofoam-HC combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. tag_IndicationsIndications

Indications And Clinical Uses: The temporary relief of anorectal inflammation, pruritus, pain and swelling associated with hemorrhoids, proctitis, cryptitis, fissures, postoperative pain and pruritus ani.

Contra-Indications: The presence of active infection, abscess, extensive fistulas or sinus tracts, tuberculosis, varicella, vaccinia, acute herpes simplex, fungal infections, patients with a known sensitivity to any of the product’s components.

Manufacturers’ Warnings In Clinical States: Contents are flammable and the aerosol container may explode if heated.

Do not insert any part of the aerosol container into the anus. Do not use in presence of open flame or spark. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.

Precautions: Do not use on infected lesions unless accompanied by appropriate anti-infective agents. Discontinue use if sensitivity develops.

A complete rectal examination to rule out any contraindicated pathology should be completed before instituting therapy.

Pregnancy and Lactation: The safety of topical corticosteroids during pregnancy and lactation has not been established. The potential benefit should be weighed in these conditions against possible hazard to the fetus or the nursing infant. When indicated, they should not be used extensively, in large amounts or for prolonged periods of time on pregnant patients or nursing mothers.

Prolonged or excessive use of this product could produce systemic corticosteroid effects. To minimize this possibility, when long-term therapy is anticipated, interrupt treatment periodically.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Adverse Reactions: Occasionally, patients may experience itching, burning and/or pain upon application of the foam.

The following local adverse reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, local irritation, striae, skin atrophy, hypertrichosis, hypopigmentation and secondary infection. When occlusive dressings are used, pustules, miliaria, folliculitis and pyoderma may occur.

Adrenal suppression has occurred with prolonged use of large doses of topical corticosteroids, particularly under occlusion due to increased percutaneous absorption.

Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No specific symptoms or therapy known. However, overdosage is improbable at the concentrations of pramoxine and hydrocortisone per 18 g unit of Proctofoam-HC. In case of accidental ingestion, institute symptomatic treatment.

Dosage: Shake the aerosol container well before using. Insert 1 applicatorful into anus 2 or 3 times daily and after each bowel evacuation. To relieve discomfort following hemorrhoidectomy, remove wing-tip cap and replace with topical cap. Transfer foam to a perianal pad and apply directly to the operative site as often as required.

Availability And Storage: Each aerosol container with anal and topical applicator contains: 18 g of a mixture of hydrocortisone acetate USP 1%, pramoxine HCl USP 1% in a water-miscible mucoadhesive foam base formulated with cetyl alcohol, emulsif- ying wax, methylparaben, propylene glycol, propylparaben, steareth-10, triethanolamine, water and inert propellants, isobutane and propane. Each application provides 375 mg of mucoadhesive base containing 1% hydrocortisone acetate USP (3.75 mg/dose) and 1% pramoxine HCl USP (3.75 mg/dose). The aerosol container contains approximately 36 applications.

Contents are flammable and are under pressure. Do not use in presence of open flame or spark. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.

PROCTOFOAM™-HC R & C Hydrocortisone Acetate – Pramoxine HCl Anorectal Therapy

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