Hydrocortisone

Description

Hydrocortisone is a white to practically white crystalline powder. Chemically, it is identified as pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-. The molecular formula is C21H30O5, and it has a molecular weight of 362.47 g/mol. The 2.5% Cream formulation contains 25 mg of hydrocortisone, USP per gram, combined with a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid, and purified water. The 2.5% Ointment formulation also contains 25 mg of hydrocortisone, USP per gram, in a base of white petrolatum and mineral oil.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These conditions may include a variety of skin disorders that respond positively to corticosteroid treatment.

There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

The medication should be applied to the affected area as a thin film, with a frequency of 2 to 4 times daily, contingent upon the severity of the condition being treated.

For the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the therapeutic effect. 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 initiate treatment with 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 employ suitable antifungal or antibacterial agents. 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. Recommended monitoring parameters include urinary free cortisol and ACTH stimulation tests. Typically, recovery of HPA axis function is rapid and complete following the cessation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the administration 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. Therefore, careful consideration and monitoring are essential in this population.

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

Side Effects

Patients may experience a range of local and systemic adverse reactions associated with the use of this medication.

Local adverse reactions are commonly reported and include burning, itching, irritation, and dryness of the skin. Other local effects may consist of folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

Systemic adverse reactions, while less frequent, can be serious. These include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

In pediatric populations, there are additional concerns regarding systemic effects. Children may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Other potential effects include linear growth retardation, delayed weight gain, low plasma cortisol levels, absence of response to ACTH stimulation, bulging fontanelles, headaches, and bilateral papilledema. It is important to note that children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Furthermore, signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids in affected patients.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

No pediatric use information is provided in the drug insert. Therefore, the safety and efficacy of this medication in pediatric patients have not been established. Healthcare professionals should exercise caution when considering this medication for children, infants, or adolescents, as there are no available data to guide dosing or treatment outcomes in these populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Corticosteroids are generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. 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 used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is advised that drugs of this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

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, caution is advised when administering topical corticosteroids due to the potential for systemic absorption and associated effects. Systemic absorption of these agents has been linked to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating monitoring in this patient population.

Patients receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider substituting with a less potent steroid.

Recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which may necessitate the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted into the bile, caution is warranted in this population.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, a potential concern for patients with compromised liver function. Therefore, patients receiving a large dose of a potent topical steroid, particularly when applied to a large surface area or under an occlusive dressing, should be evaluated periodically for signs of HPA axis suppression.

In cases where HPA axis suppression is identified, it is recommended to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Notably, recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid. Regular monitoring and appropriate adjustments are essential to ensure the safety and efficacy of treatment in patients with hepatic impairment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, studies evaluating 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, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Reports indicate that pediatric patients receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. In this population, manifestations of adrenal suppression have included linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids have been noted, particularly with the use of occlusive dressings. These reactions may 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 instructed to use this medication strictly as directed by their physician. It is intended for external use only, and they must avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should emphasize that patients must not use this medication for any condition other than the one for which it was prescribed. This ensures the safety and efficacy of the treatment.

Patients should be advised that the treated skin area should not be bandaged or covered in a manner that creates an occlusive dressing, unless specifically directed by their physician. This is important to prevent potential adverse effects.

It is crucial for patients to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing. Prompt reporting can help manage any complications that may arise.

For parents of pediatric patients, it is important to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. These garments can act as occlusive dressings, which may lead to increased risk of adverse reactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Laboratory tests that may assist in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression include the urinary free cortisol test and the ACTH stimulation test. Clinicians may consider these tests when assessing patients for potential HPA axis dysfunction.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)