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 but typically include emulsifiers, preservatives, and stabilizers to ensure product efficacy and stability.

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 irritants such as poison ivy, oak, and sumac. It is also effective for alleviating itching caused by insect bites, soaps, detergents, cosmetics, and jewelry. Additionally, this product may be used for 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:

The product should not be applied in or near the eyes due to the risk of irritation or injury. It is also contraindicated for rectal administration using fingers or any mechanical device or applicator, as this may lead to complications or adverse effects.

Additionally, the product should not be used for external feminine itching in the presence of vaginal discharge, as this may indicate an underlying condition that requires medical evaluation. It is also contraindicated for use in cases of diaper rash; consultation with a healthcare professional is advised in such instances.

Exceeding the recommended daily dosage is not advised unless directed by a healthcare provider.

Warnings and Precautions

For external use only. This product is contraindicated for application in or near the eyes, and it 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.

Prior to use, individuals should consult a doctor or pharmacist if they are currently 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 healthcare provider.

Users should discontinue use and seek medical advice if the condition worsens or fails to improve within 7 days, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with Poison Control should be established.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and awareness. The product is intended for external use only, and it is critical to avoid application in or near the eyes. Additionally, patients should not use the product by inserting it directly into the rectum using fingers or any mechanical device or applicator. It is contraindicated for external feminine itching in the presence of vaginal discharge and should not be used for diaper rash without consulting a healthcare professional.

While using this product for external anal itching, patients are advised not to exceed the recommended daily dosage unless directed by a physician. 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 sign that requires immediate medical attention.

In the event of accidental ingestion, patients should seek medical help or contact Poison Control immediately. These precautions are essential to ensure the safe use of the product and to mitigate potential adverse reactions.

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.

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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Hydrocortisone cream is not associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus associated with its use during this period. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in pregnant patients. Women of childbearing potential should be counseled accordingly, and the decision to use this medication should be made in consultation with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as necessary. It is advisable to have the product's labeling and any relevant medical history available to assist healthcare providers in determining the appropriate course of action.

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.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact Poison Control 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 healthcare professional. Lastly, it is essential to 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 a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently using any other hydrocortisone products. Patients are also instructed to discontinue use and seek medical advice if their condition worsens or fails to improve within 7 days, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

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)