Dosage & administration
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Pramosone Cream prescribing information
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 | 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.
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.
HOW SUPPLIED: Pramosone® Cream 1% 1 oz tube (NDC 54766-716-04) 2 oz tube (NDC 54766-716-03)
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 Sebela Ireland Ltd.
By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.
Distributed by Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I Roswell, GA 30076
www.sebelapharma.com Toll Free 1-844-732-3521
Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Sebela International Limited.
#6988I PI716041014
©2014 Reproduction prohibited
