Hydrocortisone

Description

Hydrocortisone is a corticosteroid with the chemical formula C21H30O5 and a molecular weight of 362.46 g/mol. It is available in various dosage forms, including topical creams, ointments, and injectable solutions. Hydrocortisone appears as a white to off-white crystalline powder, which is odorless and slightly soluble in water. The inactive ingredients may vary depending on the formulation and route of administration.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to various conditions, including eczema, psoriasis, seborrheic dermatitis, and contact with poison ivy, oak, or sumac. It is also effective for alleviating itching caused by insect bites, soaps, detergents, cosmetics, jewelry, and external feminine and anal itching.

For any other uses of this product, healthcare professionals are advised to consult a physician.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product should be applied to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching, it is recommended that the area be cleaned with mild soap and warm water when practical. After cleaning, the area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

It is important to note that this product is not indicated for use in children under 2 years of age, or in children under 12 years of age with external anal itching. In such cases, consultation with a healthcare professional is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

Application in or near the eyes is prohibited due to the potential for irritation and damage to ocular tissues.

The product should not be administered rectally, either manually or with mechanical devices or applicators, as this may lead to adverse effects or complications.

It is contraindicated for external feminine itching in the presence of vaginal discharge, as this may indicate an underlying condition that requires medical evaluation.

Additionally, the product should not be used for diaper rash without consulting a healthcare professional, as this may necessitate a different therapeutic approach.

Warnings and Precautions

For external use only. This product is contraindicated for use in or near the eyes and should not be administered directly into the rectum using fingers, mechanical devices, or applicators. It is also not recommended for external feminine itching in the presence of vaginal discharge or for diaper rash; in such cases, consultation with a healthcare professional is advised.

Healthcare professionals should counsel patients to seek medical advice before using this product if they are concurrently using any other hydrocortisone product.

When utilizing this product for external anal itching, it is imperative not to exceed the recommended daily dosage unless specifically directed by a physician.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens or fails to improve within 7 days; symptoms resolve and then recur within a few days; or if rectal bleeding is observed.

It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Side Effects

Patients using this product should be aware that it is intended for external use only. It should not be applied in or near the eyes, nor should it be administered directly into the rectum using fingers or any mechanical device or applicator. Additionally, it is contraindicated for external feminine itching in the presence of vaginal discharge and should not be used for diaper rash without consulting a doctor.

While using this product for external anal itching, patients are advised not to exceed the recommended daily dosage unless directed by a healthcare professional. If the condition worsens or does not improve within 7 days, or if symptoms resolve and then return within a few days, patients should discontinue use and consult a doctor. Rectal bleeding is another serious concern that necessitates immediate medical attention.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control center.

Drug Interactions

Concurrent use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment with additional hydrocortisone formulations. This precaution is essential to avoid potential cumulative effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age, as well as those under 12 years experiencing external anal itching, should not use this medication without consulting a healthcare professional. It is important for healthcare providers to assess the appropriateness of treatment in these age groups to ensure safety and efficacy.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for hydrocortisone cream. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to corticosteroids in this population.

Monitoring for efficacy and adverse effects is recommended, as elderly patients may respond differently to treatment. It is advisable to evaluate the patient's overall health status and any concurrent medications that may influence the safety and effectiveness of hydrocortisone cream.

Pregnancy

There is no specific information available regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the clinical situation and the absence of documented risks.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the substance is ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and provide supportive care as necessary.

Management of overdosage should include the following steps:

1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Administer appropriate supportive measures based on the symptoms presented.

3. Decontamination: If the ingestion occurred recently, consider activated charcoal if the patient is alert and able to protect their airway.

4. Symptomatic Treatment: Address any specific symptoms that arise as a result of the overdosage.

It is crucial for healthcare professionals to remain vigilant and act promptly to mitigate the effects of an overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact Poison Control immediately if the product is swallowed. It is important to inform patients that the product should not be used in or near the eyes, and they should avoid using it by inserting it directly into the rectum with fingers or any mechanical device or applicator.

Patients should be cautioned against using the product for external feminine itching if they have a vaginal discharge, and they should not use it for diaper rash without consulting a doctor. Providers should instruct patients to discontinue use and consult a doctor if their condition worsens or does not improve within 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then return within a few days, or if rectal bleeding occurs.

When using this product for external anal itching, patients should be reminded not to exceed the recommended daily dosage unless directed by a doctor. Lastly, healthcare providers should encourage patients to consult with a doctor or pharmacist before using this product if they are currently using any other hydrocortisone product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is protected from freezing to maintain its integrity and efficacy. Proper handling should be observed to prevent exposure to extreme temperatures.

Additional Clinical Information

The medication is administered topically, with application to the affected area not exceeding 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)