Analpram HC cream, 1% and 2.5%

Name: Analpram HC cream, 1% and 2.5%

Description

Analpram HC Cream is a topical preparation containing hydrocortisone acetate 1% or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor * , isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water.

Analpram HC Lotion is a topical preparation contain-ing hydrocortisone acetate 2.5% w/w and pramoxine hydro-chloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, Forlan-L, glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water.

Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formulas, the chemical names, molecular formulas and molecular weights 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

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

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.

Pharmacokinetics:   The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION .)

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage

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

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

Overdosage

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

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