Analpram HC

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION : Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

DESCRIPTION: Analpram HC ® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ® , isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23 H 32 O 6 ; mol. wt.: 404.50 pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17 H 27 NO 3 .HCl; mol. wt.: 329.87 hydrocortisone acetate pramoxinehcl

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS. )

HOW SUPPLIED: Analpram HC ® Cream 1% 1 oz tube (NDC 83107-018-01) Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx Only Manufactured for: Legacy Pharma Inc. Georgetown, Grand Cayman KY1-9012 Toll free: 1-800-727-7151 Aquaphor ® is a registered trademark of Beiersdorf AG. 69035IWK Rev. 01/25 ©2024 Reproduction prohibited