Home Papkit

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film. The frequency of application may range from two to four times daily, contingent upon the severity of the condition being treated. For conditions such as psoriasis or other recalcitrant disorders, occlusive dressings may be utilized to enhance the therapeutic effect. However, it is imperative to discontinue the use of occlusive dressings if an infection develops in the treated area.

Contraindications

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

This medication is intended for external use only and should be applied as directed by a physician. Contact with the eyes must be avoided. It is contraindicated to use this medication for any disorder other than the one for which it was prescribed. The treated skin area should not be occluded unless specifically directed by a physician. In pediatric patients, tight-fitting diapers or plastic pants should not be used in the diaper area during treatment, as these may act as occlusive dressings.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria, particularly with the use of more potent steroids, application over large surface areas, prolonged use, or the addition of occlusive dressings. Signs and symptoms of steroid withdrawal may infrequently occur, necessitating supplemental systemic corticosteroids.

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.

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 laboratory tests for this assessment include the urinary free cortisol test and the ACTH stimulation test. Should evidence of HPA axis suppression be detected, it is advisable to consider withdrawing the medication, reducing the frequency of application, or switching to a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

Particular caution should be exercised when prescribing topical corticosteroids to children, as they may absorb larger amounts relative to their body surface area, increasing their risk for systemic toxicity. In cases where irritation occurs, the use of topical corticosteroids should be halted, and appropriate alternative therapies should be initiated.

In the presence of dermatological infections, it is essential to implement suitable antifungal or antibacterial treatments. If there is no prompt improvement in the infection, the corticosteroid should be discontinued until adequate control of the infection is achieved.

Patients are advised to report any signs of local adverse reactions, especially when using occlusive dressings, to their healthcare provider.

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, although 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 is a noted greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Manifestations of adrenal suppression in children may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, have been observed.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. In cases where dermatological infections are present, appropriate antifungal or antibacterial agents should be initiated. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Drug Interactions

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 certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.

For patients receiving high doses of potent topical corticosteroids, particularly when applied to large areas of the body or under occlusive dressings, it is recommended that they undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. The urinary free cortisol test and ACTH stimulation test are both useful in monitoring potential HPA axis suppression in these patients.

Packaging & NDC

The table below lists all NDC Code configurations of Home Papkit (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

There is no specific information available 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 classified as pregnancy category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenic effects 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 the necessity of treatment and monitor for any potential effects on both the mother and the developing fetus.

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 may require careful consideration when using topical corticosteroids, as these agents are primarily metabolized in the liver and subsequently excreted by the kidneys. While specific dosing adjustments for patients with reduced kidney function are not detailed, it is important to monitor these patients closely due to the potential for altered pharmacokinetics. Additionally, some topical corticosteroids and their metabolites are excreted into the bile, which may influence their overall clearance in patients with renal impairment. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to ensure safe and effective use.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, caution is advised when administering topical corticosteroids, as their metabolism may be altered, leading to increased systemic effects. 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. Therefore, patients with hepatic impairment who are receiving a large dose of a potent topical steroid, particularly when applied to a large surface area or under an occlusive dressing, should be monitored periodically for signs of HPA axis suppression. This 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. Overall, careful evaluation and monitoring are essential for patients with compromised liver function to mitigate potential risks associated with altered drug metabolism and systemic effects.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be vigilant in monitoring for signs of overdosage, particularly in patients who may have used excessive amounts or applied the medication over large surface areas or under occlusive dressings.

In cases of suspected overdosage, it is essential to assess the patient for potential symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, hyperglycemia, and other metabolic disturbances.

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care tailored to the symptoms presented. In severe cases, particularly those involving significant systemic effects, further medical intervention may be required. Continuous monitoring and evaluation of the patient's clinical status are recommended to ensure appropriate management and recovery.

Nonclinical Toxicology

Corticosteroids are generally recognized as 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 models. However, there are no adequate and well-controlled studies in pregnant women regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be considered only when the potential benefits outweigh the 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.

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility associated with topical corticosteroids. Furthermore, studies aimed at evaluating mutagenicity with prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Local adverse reactions associated with topical corticosteroids have been reported infrequently, with an increased incidence 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.

Systemic absorption of topical corticosteroids has been associated with reversible 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 use of occlusive dressings.

Additionally, signs and symptoms of steroid withdrawal have been reported infrequently, which may necessitate the administration of supplemental systemic corticosteroids.

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 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 important to prevent potential adverse reactions.

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 them against using tight-fitting diapers or plastic pants on a child being treated in the diaper area. These garments can act as occlusive dressings, which may lead to increased risk of adverse effects.

Storage and Handling

The product is supplied in accordance with the following specifications: it should be stored at a temperature range of 20-25°C (68-77°F), adhering to the guidelines set forth by USP Controlled Room Temperature. It is imperative to keep the product out of the reach of children to ensure safety.

Additional Clinical Information

Laboratory tests relevant for monitoring include the urinary free cortisol test and the ACTH stimulation test. Clinicians should ensure that patients are informed about the proper use of the medication, which is intended for external application only and should be used strictly as prescribed. Patients must avoid contact with the eyes and should not use the medication for any conditions other than those specified by their physician.

Additionally, it is important to advise patients against occlusive dressings on treated areas unless specifically directed by a healthcare provider. Any signs of local adverse reactions, particularly under occlusive conditions, should be reported. For pediatric patients, parents should be cautioned against using tight-fitting diapers or plastic pants in the treated diaper area, as these may act as occlusive dressings.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Home Papkit as submitted by International Brand Management, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)