Proctocort

Description

Hydrocortisone is a synthetic corticosteroid classified as an anti-inflammatory and antipruritic agent. Its chemical structure is defined as pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-, with a molecular formula of C21H30O5 and a molecular weight of 362.47. Proctocort® (Hydrocortisone Cream USP), 1%, contains 10 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 drug.

Dosage and Administration

The medication should be applied to the affected area as a thin film, with frequency ranging from two to four times daily, contingent upon the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the therapeutic effect.

In the event that an infection develops, 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. This contraindication is essential to prevent potential allergic reactions that may exacerbate the patient's condition.

Warnings and Precautions

Healthcare professionals should be aware of the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression when administering this treatment. It is essential to evaluate the patient's HPA axis function to ensure safe use of the medication.

To assess HPA axis suppression, the following laboratory tests are recommended:

• Urinary Free Cortisol Test: This test measures the amount of cortisol excreted in the urine over a 24-hour period and can provide insight into adrenal function.

• ACTH Stimulation Test: This test evaluates the adrenal glands' response to adrenocorticotropic hormone (ACTH) and is useful in determining the integrity of the HPA axis.

Regular monitoring of these parameters is advised to identify any potential suppression early and to guide appropriate management strategies.

Side Effects

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

Local adverse reactions are common and 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. In cases where irritation develops, it is recommended that topical corticosteroids be discontinued and appropriate therapy instituted.

Systemic adverse reactions, although less frequent, can occur and include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

Pediatric patients are particularly susceptible to certain adverse reactions, including greater risk of topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome. Additional concerns in this population may involve intracranial hypertension, 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 signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Drug Interactions

Conditions that enhance systemic absorption of topical steroids include the use of more potent steroids, application over extensive surface areas, prolonged usage, and the incorporation of occlusive dressings.

Patients who are administered a large dose of a potent topical steroid, particularly when applied to a significant surface area or under an occlusive dressing, should undergo periodic evaluations for potential hypothalamic-pituitary-adrenal (HPA) axis suppression. Recommended assessments include the urinary free cortisol test and the ACTH stimulation test to monitor for signs of HPA axis suppression. Regular monitoring is advised to ensure patient safety and to adjust treatment as necessary based on test results.

Packaging & NDC

The table below lists all NDC Code configurations of Proctocort (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 consider that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of topical corticosteroids. While there are no specific dosage adjustments recommended for this population, caution is advised due to the potential for heightened sensitivity and the likelihood of reduced kidney function in geriatric patients.

It is important to conduct periodic evaluations for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly in patients who are receiving large doses or utilizing occlusive dressings. Additionally, geriatric patients may be at an elevated risk for systemic absorption and associated adverse effects, especially when the medication is applied over extensive surface areas or used for prolonged durations. Therefore, careful monitoring and consideration of these factors are essential when prescribing topical corticosteroids to elderly patients.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Teratogenic effects have been observed in laboratory animals when corticosteroids are administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenicity following dermal application in these 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 when the potential benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively, in large amounts, or for prolonged periods in pregnant patients 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, systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

Patients receiving large doses of potent topical steroids, especially when applied to extensive 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 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. Additionally, the potential for systemic effects from topically applied corticosteroids should be taken into account in patients with renal impairment, as sufficient absorption may occur.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, the metabolism and excretion of corticosteroids may be affected, leading to potential systemic effects. It is important to note that some topical corticosteroids and their metabolites are also excreted into the bile, which may further complicate their use in this population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This risk is particularly relevant for patients with compromised liver function. Therefore, patients receiving a large dose of a potent topical steroid, especially when applied to a large surface area or under an occlusive dressing, should be monitored periodically for signs of HPA axis suppression. Monitoring can be conducted using urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Fortunately, recovery of HPA axis function is generally prompt and complete upon discontinuation of the corticosteroid.

Given that topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, the potential for these effects may be more pronounced in patients with hepatic impairment. Therefore, careful consideration and monitoring are warranted when prescribing corticosteroids to this patient population.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in amounts sufficient to elicit systemic effects. Healthcare professionals should be aware of this possibility when prescribing or recommending these medications.

In the event of overdosage, it is crucial to monitor for potential symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, signs of adrenal suppression, Cushing's syndrome, or other hormonal imbalances.

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. Healthcare providers should assess the patient's clinical status and consider the need for further intervention based on the severity of symptoms observed. Regular monitoring and follow-up may be necessary to ensure the resolution of any adverse effects.

For specific management protocols and recommendations, healthcare professionals are advised to consult relevant clinical guidelines and 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, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Local adverse reactions associated with topical corticosteroids have been reported infrequently in postmarketing experience, with an increased occurrence noted when occlusive dressings are used. 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.

In pediatric patients, there have been reports of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension following the use of topical corticosteroids. 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.

Patients are encouraged to report any suspected adverse reactions, particularly local reactions under occlusive dressings, to Salix Pharmaceuticals at 1-800-321-4576 or to the FDA at 1-800-FDA-1088 or via www.fda.gov/medwatch. Additionally, parents of pediatric patients should be advised against the use of tight-fitting diapers or plastic pants in children being treated in the diaper area, as these may act as occlusive dressings.

Patient Counseling

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

Healthcare providers should advise patients not to use this medication for any condition other than the specific disorder for which it was prescribed. It is important to ensure that patients understand the necessity of adhering to the prescribed use to avoid complications.

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. This is crucial to prevent potential adverse effects.

Additionally, patients should be 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 essential 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, potentially exacerbating skin reactions or interfering with the treatment's effectiveness.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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. These assessments can provide valuable insights for clinicians managing patients potentially affected by HPA axis dysfunction.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Proctocort as submitted by Salix Pharmaceuticals, Inc. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)