Pramoxine-HC Otic Drops

Generic name: hydrocortisone, chloroxylenol and pramoxine hydrochloride
Dosage form: otic liquid
Drug class:Otic steroids with anti-infectives

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

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

DESCRIPTION:
Each 1 mL for otic administration contains:
Hydrocortisone .....10 mg
Chloroxylenol .....1 mg
Pramoxine HCl .....10 mg

Inactive ingredients: In an aqueous vehicle containing Isopropyl Alcohol and Propylene Glycol.
Hydrocortisone (cortisol) (11ß, 17,21-trihydroxy pregn-4-ene-3,20-dione) is an anti-inflammatory and antipruritic agent. Chloroxylenol is a broad spectrum bactericidal agent which occurs as white crystals with a phenolic odor. It is soluble in alcohol, ether and alkali hydroxides. Chemically it is (4-chloro-3,5-dimethyl phenol or meta-chloroxylenol). Pramoxine (4-[3-(butoxyphenoxy)propyl-]morpholine), used as the hydrochloride salt, is a topical anesthetic.

CLINICAL PHARMACOLOGY:
This product is effective as both an antibacterial and antifungal agent. Hydrocortisone is a corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory action of topical corticosteroids is not clear. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to the systemically-administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Metabolized primarily in the liver, corticosteroids are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Chloroxylenol in low concentrations is a germicide that may be used to treat bacterial and fungal infections. It is halogenated phenol, non-toxic, non-corrosive, non-staining with high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity to