What is MiCort HC and how is it used?
MiCort HC is an over the counter and prescription medicine used to treat the symptoms of Atopic Dermatitis and Corticosteroid-responsive Dermatoses. MiCort HC may be used alone or with other medications.
MiCort HC belongs to a class of drugs called Corticosteroids, Topical.
It is not known if MiCort HC is safe and effective in children younger than 2 years of age.
What are the possible side effects of MiCort HC?
MiCort HC may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- worsening of your skin condition,
- redness, warmth, welling, oozing, or severe irritation on any treated skin,
- increased thirst,
- increased urination,
- dry mouth,
- fruity breath odor,
- weight gain (especially in your face or your upper back and torso),
- slow wound healing,
- thinning or discolored skin,
- increased body hair,
- muscle weakness,
- mood changes,
- menstrual changes, and
- sexual changes
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of MiCort HC include:
- burning and itching of the skin with pinhead-sized red blisters,
- burning, itching, and pain in hairy areas,
- pus at the root of the hair,
- 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, and
- softening of the skin
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of MiCort HC. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
MiCort™ HC Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w in a water washable base containing cetostearyl alcohol, ceteth 20, light mineral oil, petrolatum, propylparaben, butylparaben, citric acid, sodium citrate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents.
The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-C23H32O6; mol. wt.: 404.50
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
DOSAGE AND ADMINISTRATION
Topical corticosteroids are 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.
|MiCort™ HC Cream 2.5%||1 oz tube||(NDC 54766-835-04)|
|30 x 4 gram tubes||(NDC 54766-835-65)|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Protect from freezing.
Keep out of reach of children. Keep tube closed when not in use.
Manufactured for Sebela Ireland Ltd. By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A. Distributed by : Sebela Pharmaceuticals Inc., 645 Hembree Parkway, Suite I, Roswell, GA 30076. Revised: Dec 2017
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:
Maceration of the skin
No Information provided
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. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area and 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 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 following tests may be helpful in evaluating the HPA axis suppression:
Urinary free Cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, And 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 and hydro-cortisone have revealed negative results.
Pregnancy Category C
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 amounts 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 intra-cranial 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.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar 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 and their metabolites are also excreted into the bile.
Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressings.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Skin Problems and Treatments Resources
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Health Solutions From Our Sponsors