Pram cream/ontment

Prescribing Information
NOVACORT® gel

DESCRIPTION
Each gram of Novacort® contains 2.0% (20 mg) Hydrocortisone acetate and 1.0% (10
mg) Pramoxine hydrochloride (HCI). Also contains 1.0% (10 mg) Aloe polysaccharide
and 5.0% (50 mg) Biopeptide combination of Palmitoyl oligopeptide, Polyglyceryl
methacrylate and Propylene glycol. Other ingredients: Benzyl alcohol, 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:

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 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.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
WARNINGS AND PRECAUTIONS
General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-
pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome,
hyperglycemia, and glucosuria in some patients. Conditions which augment systemic
absorption include the application of the more potent steroids, use over large surface
areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied over a large
surface area and under an occlusive dressing should be evaluated periodically for the
evidence of HPA axis suppression by using the urinary free cortisol and ACTH
stimulation tests. If HPA axis suppression is noted, an attempt should be made to
withdraw the drug, to reduce the frequency of application, or to substitute a less potent
steroid.
Recovery of HPA axis function is usually prompt and complete upon discontinuation of
the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring
supplemental systemic corticosteroids. Children may absorb proportionally larger
amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
(See WARNINGS AND PRECAUTIONS-Pediatric Use.) Keep out of reach of children.
If irritation develops, topical corticosteroids should be discontinued and appropriate
therapy instituted. Burning, itching, Irritation and dryness have been reported
infrequently following the use of topical corticosteroids.
In the presence of dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does not occur promptly,
the corticosteroid should be discontinued until the infection has been adequately
controlled.
Information for the Patient:
Patients using topical corticosteroids should receive the following information and
instructions:
1. This medication is to be used as directed by the physician. It is for external use 2. Patients should be advised not to use this medication for any disorder other than 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests:
The following tests may be helpful in evaluating the HPA axis suppression: (1) Urinary
free cortisol test; and (2) ACTH stimulation test.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of topical corticosteroids. Studies to determine
mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy. Teratogenic Effects. Category C:
Corticosteroids are generally teratogenic in laboratory animals when administered
systemically at relatively low dosage levels. The more potent corticosteroids have been
shown to be teratogenic after dermal application in laboratory animals. There are no
adequate and well-controlled studies in pregnant women on teratogenic effects from
topically applied corticosteroids. Therefore, topical corticosteroids should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in large
amounts, or for prolonged periods of time.
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.
Pediatric Use:
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-
induced HPA axis suppression and Cushing’s syndrome than mature patients because
of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and
intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation,
delayed weight gain, low plasma cortisol levels, and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include; bulging fontanelles,
headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount
compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of children.

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 infections, Skin Atrophy, Striae, and Miliaria.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce
systemic effects. (See WARNINGS AND PRECAUTIONS.)
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) 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.
HOW SUPPLIED
PACKAGE
10 count carton of 2.0 gram gel sample packs - not for resale
Each 2.0 gram gel pack contains multiple doses depending on the surface area treated.
STORAGE
Store at room temperature 15º-30ºC (59º-86ºF).
Keep tightly closed.
Rx only

www.novacort.com

U.S. Patents
#6,436,679; #6,271,214; #6,133,440; and #5,708,038
Distributed by:
Primus Pharmaceuticals, Inc.
Scottsdale, AZ 85251

Manufactured by:
Ei Inc
Kannapolis, NC 28083
2011 Primus Pharmaceuticals, Inc. All rights reserved. ISS. 1211 #12001

Source: http://www.novacort.com/Novacort_Pi.pdf