Novacort

Each gram of Novacort contains 2.0% (20 mg) Hydrocortisone Acetate and 1.0% (10 mg) Pramoxine Hydrochloride (HCI). Other Ingredients: Aloe Polysaccharide, Benzyl Alcohol, Biopeptide CL, Cetyl Alcohol, Dimethicone, Dimethyl Isosorbide, Glycerin, Glyceryl Stearate, Hydroxypropyl Methylcellulose, PEG-100 Stearate, Phenoxyethanol, Poloxamer 407, Propylene Glycol, Purified Water, Stearoxytrimethylsilane, Stearyl Alcohol, and Witch Hazel Distillate.

Hydrocortisone Acetate
Hydrocortisone Acetate is a topical corticosteroid anti-inflammatory and anti-pruritic agent. Chemically, Hydrocortisone Acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-C23H32O6] with a molecular weight of 404.50. Chemically, Hydrocortisone Acetate is represented by the following structural formula:

Pramoxine Hydrochloride
Pramoxine Hydrochloride (Pramoxine HCl) is a topical anesthetic agent. Chemically, Pramoxine Hydrochloride is [4-(3-(p-butoxyphenoxy)propyl) morpholine Hydrochloride

C17H27NO3. • HCI] with a molecular weight of 329.87. Chemically, Pramoxine Hydrochloride is represented by the following structural formula: 

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 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 the nerve endings with which it comes into contact.

Pharmacokinetics

The extent of percutaneous absorption of topical steroids 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 of topical corticosteroids. 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 corticosteroids and their metabolites are also excreted into the bile.

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

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 infections, skin atrophy, striae, and miliaria. Possible local adverse reactions associated with pramoxine include burning and stinging.

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) in accordance with physician’s directions or as directed otherwise by a physician. 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. Use with occlusive dressings or diapers should be under physician supervision.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

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Chicago, IL 60654

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