Hydrocortisone and Pramoxine Suppository

Generic name: hydrocortisone acetate and pramoxine hydrochloride
Dosage form: suppository
Drug class:Anorectal preparations

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

For Rectal Administration

Rx Only

Hydrocortisone and Pramoxine Suppository Description

Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy–(11b) with the following structural formula:

Pramoxine Hydrochloride is a topical anesthetic agent designed chemically as 4-(3-(butoxyphenoxy)propyl)morpholine hydrochoride with the following structural formula:

Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg and pramoxine hydrochloride, USP 18 mg in a specially blended hydrogenated vegetable base.

Hydrocortisone and Pramoxine Suppository - Clinical Pharmacology

In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces.

Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Indications and Usage for Hydrocortisone and Pramoxine Suppository

Hydrocortisone acetate and pramoxine hydrochloride suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

Contraindications

Hydrocortisone acetate and pramoxine hydrochloride suppositories are contraindicated in those patients having a history of hypersensitivity to...