Get your patient on Analpram Hc (Hydrocortisone Acetate And Pramoxine Hydrochloride)

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Analpram Hc prescribing information

Indications & Usage

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

Dosage & Administration

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

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

Adverse Reactions

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

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.

Referenced Image

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

Referenced Image

pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C 17 H 27 NO 3 .HCl; mol. wt.: 329.87

Pharmacology

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.

How Supplied/Storage & Handling

HOW SUPPLIED:

Analpram HC ​® ​Cream 2.5% 1 oz tube                  (83107-019-01)

12 x 4 gram tubes     (83107-019-12)

30 x 4 gram tubes     (83107-019-30)

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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