CORMAX SCALP APPLICATION - clobetasol propionate solution 
DPT Laboratories, Ltd.

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Cormax
Scalp Application, 0.05% w/w
(Clobetasol Propionate Topical Solution, USP)
Rx only


Revised: May 2006
128430-0506

For Dermatologic Use Only
Not for Ophthalmic Use

DESCRIPTION

Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17-propionate, and it has the following structural formula:
Clobetasol_structural_formula
Clobetasol propionate has the molecular formula C25H32ClF05 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Each gram of Cormax Scalp Application contains 0.5 mg clobetasol propionate in a base composed of purified water, isopropyl alcohol (40% w/w), carbomer 934P, and sodium hydroxide.

CLINICAL PHARMACOLOGY

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.

Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see  DOSAGE AND ADMINISTRATION).

As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see  DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly 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, including clobetasol propionate and its metabolites, are also excreted in the bile.

Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) has the potential to depress plasma cortisol levels in some patients. However, hypothalamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a two-week course of treatment.

INDICATIONS AND USAGE

Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 mL per week because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in pediatric patients under 12 years of age.

CONTRAINDICATIONS

Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

PRECAUTIONS


General

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions that augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroid applied to a large surface area should be evaluated periodically for 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 generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Irritation is possible if Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.

In the presence of dermatologic 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.

Although Cormax Scalp Application is intended for the treatment of inflammatory conditions of the scalp, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.

As with other potent topical corticosteroids, Cormax Scalp Application should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.

Information for Patients

Patients using Cormax Scalp Application should receive the following information and instructions:

1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it is prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.
4. Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests

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

Carcinogenesis, Mutagenesis, 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 have revealed negative results.

Pregnancy: Teratogenic Effects: Pregnancy Category C

The more potent corticosteroids have been shown to be teratogenic in animals after dermal application. Clobetasol propionate has not been tested for teratogenicity by this route; however, it  is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential  than steroids that are less potent.

There are no adequate and well-controlled studies of the teratogenic effects of topically applied corticosteroids, including clobetasol, in pregnant women. Therefore, clobetasol and other topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and they 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 quantities 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 prescribed for a nursing woman.

Pediatric Use

Use of Cormax Scalp Application in pediatric patients under 12 years of age is not recommended.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression. Cushing's syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in  pediatric patients 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.

ADVERSE REACTIONS

Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) is generally well tolerated when used for two-week treatment periods.

The most frequent adverse events reported have  been local and have included burning and/or stinging sensation, which occurred in approximately 10% of the patients; scalp pustules, which occurred in approximately 1 % of the patients; and tingling, and folliculitis, each of which occurred in approximately 0.6% of the patients. Less frequent adverse events were itching and tightness
of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in approximately 0.3% of the patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

OVERDOSAGE

Topically applied Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP) can be absorbed in sufficient amounts to produce systemic effects (see  PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Cormax Scalp Application (Clobetasol Propionate Topical Solution , USP) should be applied to the affected scalp areas twice daily, once in the morning and once at night. Cormax Scalp Application is potent; therefore, treatment must be limited to two consecutive weeks and amounts greater than 50 mL per week should not be used. Carmax Scalp Application is not to be used with occlusive dressings.

HOW SUPPLIED

Cormax Scalp Application (Clobetasol Propionate Topical Solution, USP), 0.05% w/w is supplied in plastic squeeze bottles of 25 mL (NDC 55515-430-25), and 50 mL (NDC 55515-430-50).

Store at controlled room temperature 15-30°C (59-86°F). Do not refrigerate. Do not use near an open flame.

Rx only

Revised: May 2006

Mfd. for
Oclassen
DERMATOLOGICS

A Division of
Watson Pharma, Inc.,
Corona, CA 92880 USA

by DPT Labs, Ltd.,
San Antonio ,TX 78215


128430-0506

Package Label - Principal Display Panel

50 mL                    NDC 55515-430-50          

Cormax Scalp Application 0.05% w/w
(Clobetasol Propionate Topical Solution, USP)

For Dermatologic Use Only
Not For Ophthalmic Use

Rx Only
Cormax_Scalp_Appl_50_FL
Cormax_Scalp_Appl_50_CTN

CORMAX  SCALP APPLICATION
clobetasol propionate   solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63094-5430
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE B 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163094-5430-523.125 g In 1 BOTTLE, PLASTICNone
263094-5430-046.25 g In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07422001/09/199712/31/2009

Labeler - DPT Laboratories, Ltd. (832224526)
Revised: 05/2010DPT Laboratories, Ltd.