Hydrocortisone

Description

Hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11Β)-. Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP. The vehicle of ALA-SCALP includes isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride.

Uses and Indications

Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses.

Limitations of Use: There are no teratogenic or nonteratogenic effects reported in the available data.

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

Hydrocortisone Lotion is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation. Use in these individuals may lead to severe allergic reactions.

Warnings and Precautions

Rx only. This product is intended for external use only and is not suitable for ophthalmic use.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Factors that may increase systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the use of occlusive dressings.

Patients receiving high doses of potent topical steroids, particularly when applied to extensive areas or under occlusive dressings, should be monitored periodically for signs of HPA axis suppression. Recommended laboratory tests for this evaluation include the urinary free cortisol test and the ACTH stimulation test. If evidence of HPA axis suppression is detected, it is advisable to withdraw the drug, reduce the frequency of application, or consider substituting a less potent steroid. Recovery of HPA axis function typically occurs promptly and completely upon discontinuation of the drug; however, in rare cases, signs and symptoms of steroid withdrawal may arise, necessitating the use of supplemental systemic corticosteroids.

Pediatric patients may be at an increased risk for systemic toxicity due to the proportionally larger amounts of topical corticosteroids they may absorb. In cases where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate therapeutic measures should be initiated. Additionally, in the presence of dermatological infections, it is essential to employ an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid should be discontinued until the infection is adequately controlled.

Side Effects

Patients may experience a range of local adverse reactions associated with the use of topical corticosteroids. Common local reactions include burning, itching, irritation, and dryness. Other local effects may manifest as folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria. In cases where irritation develops, it is recommended that the topical corticosteroid be discontinued and appropriate therapy initiated.

Systemic absorption of topical corticosteroids has been observed, leading to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression in some patients. This may result in manifestations of Cushing's syndrome, hyperglycemia, and glucosuria. Signs and symptoms of steroid withdrawal may also occur, necessitating the use of supplemental systemic corticosteroids.

In pediatric patients, the use of topical corticosteroids has been associated with 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 an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

In the presence of dermatological infections, it is crucial to initiate the use of an appropriate antifungal or antibacterial agent. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

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 warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Hydrocortisone (hydrocortisone lotion), 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 ACTH stimulation. Symptoms 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. Prolonged use of corticosteroids may adversely affect the growth and development of pediatric patients.

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

Pregnant patients should be aware that this medication is classified as Pregnancy Category C. Corticosteroids, including those in this class, have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in animal studies.

Currently, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids. Therefore, the use of topical corticosteroids during pregnancy should be considered only if the potential benefits outweigh the potential risks to the fetus. It is advised that drugs in 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

Monitoring should continue until the patient is stable and any potential complications are addressed. Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is critical for ongoing management and future reference.

Healthcare professionals are encouraged to familiarize themselves with local protocols and guidelines regarding overdose management to ensure optimal patient outcomes.

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, 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 use 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 switch to a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may necessitate the use of supplemental systemic corticosteroids.

Pediatric patients may experience proportionally greater absorption of topical corticosteroids, making them more susceptible to systemic toxicity. Reports of HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been documented in this population. Manifestations of adrenal suppression in pediatric patients can 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.

Local adverse reactions associated with topical corticosteroids are infrequent but may occur more frequently 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.

For reporting suspected adverse reactions, individuals are encouraged to contact Allegis Holdings, LLC at 1-866-633-9033 or the FDA at 1-800-FDA-1088 or visit https://fda.gov/Safety/MedWatch/.

Patient Counseling

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

It is important for healthcare providers to emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. Additionally, patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.

Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for reevaluation of the treatment plan.

For parents of pediatric patients, it is crucial to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area, as these garments may act as occlusive dressings and could exacerbate potential side 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 ºC (68 to 77 ºF), as defined by the United States Pharmacopeia (USP) guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may benefit from specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Allegis Holdings LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)