Hydrocortisone

Description

Hydrocortisone is a white to off-white, odorless, crystalline powder. It is characterized by its solubility in alcohol and chloroform, with slight solubility in water. The chemical name of hydrocortisone is 11β,17,21-trihydroxypregn-4-ene-3,20-dione, and its molecular formula is C21H30O5. The molecular weight of hydrocortisone is 362.46. Inactive ingredients include citric acid, sodium citrate, sodium chloride, and water for injection.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor irritations and rashes. Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers accordingly to prevent misuse in this age group.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, use is contraindicated if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In these instances, discontinue use and consult a doctor before initiating any other hydrocortisone product. Furthermore, do not use if the packaging is broken.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is contraindicated for the treatment of diaper rash; patients should be instructed to consult a physician for appropriate management in such cases.

In instances where the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients must discontinue use of this product. They should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Additionally, the product should not be used if the packaging is broken, as this may compromise safety and efficacy. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate contact with a Poison Control Center is essential for appropriate management.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes. It is contraindicated for the treatment of diaper rash; patients are advised to consult a doctor for appropriate treatment options in such cases.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not use this product if the packaging is broken.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 should not use this medication. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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.

Pregnancy

Hydrocortisone cream has not been 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 fetal outcomes. As such, healthcare professionals should consider the benefits and risks of hydrocortisone cream use in pregnant patients on a case-by-case basis, taking into account the lack of specific data regarding its safety profile in this population.

Lactation

There is no specific information available regarding the use of Hydrocortisone cream in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, immediate action is crucial. If the substance is ingested, it is imperative to contact a Poison Control Center without delay.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the specific substance involved. Monitoring the patient for any adverse effects is essential, and supportive care should be provided as necessary.

Management procedures may include symptomatic treatment and monitoring of vital signs. It is important to follow established protocols for the specific substance in question, as well as any additional recommendations from the Poison Control Center.

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 contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash, and they should consult a doctor for appropriate alternatives.

Patients should be made aware that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product. They should not begin using any other hydrocortisone product without first consulting a doctor.

Additionally, healthcare providers should instruct patients to avoid using the product if the packaging is broken, as this may indicate compromised safety or efficacy.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. It is contraindicated for use in children under 2 years of age. There is no additional information available regarding laboratory tests, abuse potential, 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)