Anusol hc

Overdose

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

Anusol HC price

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 the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Therapeutic indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Date of revision of the text

Name of the medicinal product

Qualitative and quantitative composition

Anusol-HC® 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30).

Store at 20°–25°C (68°–77°F). See USP controlled room temperature. Store away from heat. Protect from freezing.

Manufactured for: Salix Pharmaceuticals, Inc., Raleigh, NC 27615. Revised: Oct 2011

Special warnings and precautions for use

No information provided.

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 addition of occlusive dressings.

If HPA axis suppression is noted (by using the urinary free cortisol and ACTH stimulation tests) an attempt should be made to withdraw the drug or to reduce the frequency of application.

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. 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 urinary free cortisol test and the ACTH stimulation test may be helpful in evaluating the HPA axis suppression.

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteriods. Studies to determine mutagenicity with 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 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 administered to a nursing woman.

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 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.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Dosage (Posology) and method of administration

Anusol-HC® 2.5% (Hydrocortisone Cream, USP) should be applied to the affected area 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 the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

No information provided.