Alacort

Description

Hydrocortisone is chemically defined as pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5, and it has a molecular weight of 362.47 g/mol. ALA-CORT (Hydrocortisone Cream USP) is available in two strengths: the 1% formulation contains 10 mg of hydrocortisone USP per gram in a cream base, while the 2.5% formulation contains 25 mg of hydrocortisone USP per gram in a cream base. The cream base is composed of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, and sorbic acid.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of two to four times daily, depending on the severity of the condition being treated.

For the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment. However, if an infection occurs, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should be initiated to address the infection.

Contraindications

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

In cases of irritation, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, in the presence of dermatological infections, it is essential to use an appropriate antifungal or antibacterial agent. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate therapeutic measures should be initiated.

In cases where dermatological infections are present, it is imperative to administer an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid treatment should be halted until the infection is adequately managed.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. If evidence of HPA axis suppression is detected, it is advisable to withdraw the corticosteroid, reduce the frequency of application, or consider switching to a less potent steroid. Generally, recovery of HPA axis function occurs swiftly and completely upon discontinuation of the corticosteroid; however, in rare instances, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, rendering them more vulnerable to systemic toxicity.

For monitoring HPA axis suppression, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test.

Side Effects

Patients using topical corticosteroids may experience a range of local adverse reactions. Commonly reported reactions include burning, itching, irritation, and dryness of the skin. Other local effects may include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

In addition to local reactions, systemic absorption of topical corticosteroids has been associated with serious adverse effects. Some patients may experience reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which can lead to manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Signs and symptoms of steroid withdrawal may also occur, necessitating the use of supplemental systemic corticosteroids.

Particular caution is warranted in pediatric patients, as reports indicate that they may be at increased risk for HPA axis suppression, Cushing’s syndrome, and intracranial hypertension when using topical corticosteroids. Manifestations of adrenal suppression in this population can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Alacort (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome compared to mature patients, primarily due to a larger skin surface area relative to body weight. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.

Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to adrenocorticotropic hormone (ACTH) stimulation. Additionally, signs of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

To mitigate these risks, the administration of topical corticosteroids in pediatric patients should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. It is important to note that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated teratogenic effects associated with systemic administration of corticosteroids at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenicity following dermal application in laboratory animals. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only when the anticipated benefits outweigh the potential risks to the fetus. It is advised that these medications not be used extensively, in large amounts, or for prolonged periods in pregnant patients to minimize any potential adverse fetal outcomes. Healthcare professionals should carefully consider these factors when prescribing corticosteroids to women of childbearing potential.

Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.

Caution should be exercised when topical corticosteroids are administered to lactating mothers.

Renal Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with renal impairment, systemic absorption of topical corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

For patients receiving large doses of potent topical steroids applied to extensive areas or under occlusive dressings, periodic evaluation for HPA axis suppression is recommended. This can be assessed through urinary free cortisol and ACTH stimulation tests. Should HPA axis suppression be detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver, with subsequent excretion occurring via the kidneys. In patients with hepatic impairment, the metabolism and clearance of corticosteroids may be affected, necessitating careful consideration of dosing and monitoring.

Topical corticosteroids and their metabolites are also excreted into the bile, which may further complicate their use in individuals with compromised liver function. Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This potential effect raises particular concerns for patients with hepatic impairment, who may be at increased risk for such suppression.

For patients receiving a large dose of a potent topical steroid, especially when applied to a large surface area or under an occlusive dressing, it is essential to evaluate them periodically for evidence of HPA axis suppression. Monitoring should include assessments of urinary free cortisol levels and ACTH stimulation tests to ensure that any adverse effects on the HPA axis are identified and managed appropriately.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be indicated, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the addition of occlusive dressings.

Patients receiving high doses of potent topical steroids applied to extensive areas or under occlusive dressings should be periodically evaluated for signs of HPA axis suppression, utilizing urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is recommended to withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Recovery of HPA axis function is typically prompt and complete upon discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may necessitate supplemental systemic corticosteroids.

Pediatric patients may exhibit increased susceptibility to HPA axis suppression and Cushing’s syndrome due to a higher skin surface area to body weight ratio. Reports indicate that pediatric patients receiving topical corticosteroids have experienced HPA axis suppression, Cushing’s syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids may occur, particularly with the use of occlusive dressings. These reactions include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Patient Counseling

Patients should be informed that this medication is to be used strictly as directed by their physician and is intended for external use only. They must be cautioned to avoid contact with the eyes to prevent irritation or injury.

It is essential for patients to understand that this medication should not be used for any condition other than the specific disorder for which it was prescribed. They should be advised against bandaging or covering the treated skin area in a manner that creates an occlusive environment, unless specifically instructed by their physician.

Patients are encouraged to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for medical evaluation or adjustment of treatment.

For parents of pediatric patients, it is important to advise them against using tight-fitting diapers or plastic pants on children receiving treatment in the diaper area. Such garments may act as occlusive dressings and could potentially exacerbate any adverse effects.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20 to 25 °C (68 to 77 °F), as defined by the United States Pharmacopeia (USP). It is essential to ensure that the storage conditions are maintained within this temperature range to preserve the integrity and efficacy of the product.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test as helpful tools in this assessment. These tests can provide valuable insights into the functioning of the HPA axis in subjects under evaluation.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Alacort as submitted by Crown Laboratories. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)