Carmol (corticosteroids)

Overdose

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Undesirable effects

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1:

Therapeutic indications

CARMOL® HC (Hydrocortisone Acetate Cream USP, 1%) is indicated forthe relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Name of the medicinal product

Carmol (CORTICOSTEROIDS) price

Qualitative and quantitative composition

CARMOL® HC (Hydrocortisone Acetate Cream USR1%) is supplied in:

1 oz. (28 g) tube NDC 10337-550-52
3 oz. (85 g) tube NDC 10337-550-19

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Pharmacist: Dispense in tight containers as specified in DSP.

Manufactured for: Doak Dermatologics, A Subsidiary Of Bradleyfharmaceuiicais, Inc., Fairfield, New Jersey 07004-2402 USA. www.bradpharm.com. Manufactured by: Entreprises Importfab, Inc. Pointe-Claire, QC CANADA

Special warnings and precautions for use

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-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 additions of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, 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. (See PRECAUTIONS-Pediatric Use.) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. 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.

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

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the affect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

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.

It is not known whether topical 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 administered to a nursing woman.

Pediatric patients may demonstrate greater susceptibility to a topical corticos-teroid-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.

Dosage (Posology) and method of administration

CARMOL® HC (Hydrocortisone Acetate Cream DSP, 1%) is generally applied to the affected area as a thin film two to four times daily, depending on the severity of the condition. 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.

Interaction with other medicinal products and other forms of interaction

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1:

No information provided.