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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

Additionally, this drug provides temporary relief for external anal and genital itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area, not exceeding 3 to 4 applications per day. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge, as this may indicate an underlying condition that requires medical evaluation. Additionally, it is advised to consult a healthcare professional for the treatment of diaper rash to ensure appropriate care.

During use, it is essential to avoid contact with the eyes to prevent irritation. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated to avoid potential injury or complications.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application in the genital area in the presence of vaginal discharge. Healthcare professionals should advise patients to consult a physician for the appropriate treatment of diaper rash.

While using this product, it is imperative to avoid contact with the eyes. Patients should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Patients must be advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. Additionally, the use of any other hydrocortisone product should not commence without prior consultation with a healthcare professional.

In the event of rectal bleeding, patients should stop using the product and consult a doctor immediately. If the product is ingested, it is crucial to seek medical assistance or contact Poison Control without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor for the treatment of diaper rash.

During the use of this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a healthcare professional. Additionally, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, patients should not begin the use of any other hydrocortisone product without consulting a doctor. In the event of rectal bleeding, immediate medical consultation is also recommended.

This product should be kept out of reach of children. If swallowed, patients should seek medical assistance or contact a Poison Control center promptly.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application. The same frequency of application, not more than 3 to 4 times daily, applies. For children under 12 years of age, consultation with a doctor is recommended before use.

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

The available data does not indicate any specific warnings or precautions regarding the use of hydrocortisone cream during pregnancy. There are no contraindications noted for its use in pregnant patients, nor are there any recommended dosage modifications or safety concerns associated with its application during this period. Healthcare professionals should consider the benefits and risks when prescribing hydrocortisone cream to women of childbearing potential, although current evidence does not suggest significant fetal risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, it is essential to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of the 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic contact dermatitis, and other hypersensitivity reactions. These events have been documented in the context of routine pharmacovigilance activities.

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 the genital area if they have a vaginal discharge. Patients should be encouraged to consult a doctor for the treatment of diaper rash.

Providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be cautioned against using any other hydrocortisone product without first consulting a doctor. Additionally, patients should be informed to stop use and seek medical advice if rectal bleeding occurs.

While using this product, patients must be reminded to avoid contact with the eyes. It is essential to communicate that patients should not exceed the directed dosage unless specifically instructed to do so by a doctor. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

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 a controlled temperature range of 20 to 25 °C (68 to 77 °F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The route of administration for the product is topical. 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)