Pramosone Cream

(Hydrocortisone Acetate And Pramoxine Hydrochloride)

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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.

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Pramosone Cream Prescribing Information

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	Hypertrichosis	Maceration of the skin
Itching	Acneiform eruptions	Secondary infection
Irritation	Hypopigmentation	Skin atrophy
Dryness	Perioral dermatitis	Striae
Folliculitis	Allergic contact dermatitis	Miliaria

DESCRIPTION: Pramosone ® Cream 1%

is a topical preparation
containing hydrocortisone acetate 1% 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.

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

₂₃H

₃₂O

₆; mol.wt.: 404.50

Referenced Image

pramoxine hydrochloride

4-(3-(p-butoxyphenoxy)propyl)morpholine
hydrochloride

C

₁₇H

₂₇NO

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.

Pramosone Cream

Dosage & Administration

Pramosone Cream Prescribing Information

Pramosone Cream Prior Authorization Resources

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