FEVICID Cream Ref.[115682] Active ingredients: Clobetasol propionate Clotrimazole

General

Clotrimazole should be used cautiously during pregnancy. It should be used with caution in patients with medical history or allergies. Topical application of clotrimazole is contraindicated in the children under the age of 2, unless recommended by the physician.

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing' 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 a 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.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

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.

Certain areas of the body, such as the face, groin, and axillae, are more prone to 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, Clobetasol Propionate Cream 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 Clobetasol Propionate Cream should receive the following information and instructions:

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.

This medication should not be used for any disorder other than that for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.

Patients should report any signs of local adverse reactions to the physician.

None have been reported on local application. Avoid using other topical medications, harsh or abrasive soaps, or cosmetics on the affected area.

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 this Cream in children under 12 years of age is not recommended. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing' syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing' 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.

Clotrimazole has not been associated with teratogenic effects but following oral administration of high doses to rats, there was evidence of fetotoxicity. The relevance of this effect to topical application in humans is not known. However, clotrimazole has been used in pregnant patients for over a decade without attributable effects. It is therefore recommended that clotrimazole should be used in pregnancy only when considered necessary by the clinician.

The medicinal product has no influence on the ability to drive or operate machinery.

FEVICID CREAM is generally well tolerated when used for two-week treatment periods. Burning sensation, stinging sensation, Erythema, stinging, irritation; hypersensitivity reactions; contact dermatitis, and itching of skin may occur on applied portion which disappear shortly after application.

Use of large amounts of FEVICID CREAM over prolonged periods can lead to sufficient systemic levels, which produces adrenal suppression, Cushing's syndrome.

None known.