Pramcort Cream

Name: Pramcort Cream

Pramcort Cream - 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 & usage

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

Laboratory tests

The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test.

Nursing mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.  Systemically administered corticosteroids are secreted into breast milk in quantities NOT likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Dosage & 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.

Label and Carton

label

carton

PRAMCORT 
hydrocortisone acetate and pramoxine hydrochloride cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-150
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 10 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN  
CETYL ALCOHOL  
ISOPROPYL PALMITATE  
LANOLIN ALCOHOLS  
MINERAL OIL  
PANTHENOL  
POLYOXYL 40 STEARATE  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
WATER  
SORBIC ACID  
STEARIC ACID  
TRIETHANOLAMINE LAURYL SULFATE  
PETROLATUM  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:49908-150-30 1 TUBE, WITH APPLICATOR in 1 CARTON
1 30 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/30/2011
Labeler - Rochester Pharmaceuticals (134473771)
Revised: 07/2017   Rochester Pharmaceuticals
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