Cormax

Cormax is a brand name medication included in a group of medications called Corticosteroids, very potent group IV. For more information about Cormax see its generic Clobetasol

Cormax is part of the drug class:

• Corticosteroids, very potent group IV

You should not use clobetasol topical if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have:

• any type of skin infection.

Steroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

FDA pregnancy category C. It is not known whether clobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether clobetasol topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Clobetasol topical should not be given to a child younger than 12 years old. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning or stinging at the application site

Less common

• Burning sensation of the skin
• dry skin
• flushing or redness of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• skin irritation
• skin rash, encrusted, scaly and oozing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)

Incidence not known

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• hair loss
• redness and scaling around the mouth
• thinning of the hair
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cough
• sore throat

Less common

• Body aches or pain
• changes in skin coloring
• congestion or cough
• dryness or soreness of the throat
• headache
• raised, dark red, wart-like spots on the skin, especially when used on the face
• skin discomfort
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Rx only
For Dermatologic Use Only - Not for Ophthalmic Use.

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 into the bile.

Clobetasol propionate ointment has been shown to depress the plasma levels of adrenal cortical hormones following repeated nonocclusive application to diseased skin in patients with psoriasis and eczematous dermatitis. These effects have been shown to be transient and reversible upon completion of a two-week course of treatment.

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.

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

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.

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.

Cormax Ointment is generally well tolerated when used for two-week treatment periods. The most frequent adverse reactions reported for clobetasol propionate ointment have been local and have included burning sensation, irritation, and itching. These occured in approximately 0.5% of the patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of  fingers, skin atrophy, and telangiectasia, 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 dermatifis, 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.

A thin layer of Cormax Ointment should be applied with gentle rubbing to the affected skin area twice daily, once in the morning and once at night.

Cormax Ointment is potent; therefore, treatment must be limited to two consecutive weeks, and amounts greater than 50 g per week should not be used, Cormax Ointment is not to be used with occlusive dressings.