Hydrocortisone

Description

No description information is available for the specified drug.

Uses and Indications

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

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 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 physician prior to use.

In cases of external anal and genital itching, adults should first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is recommended before application.

Contraindications

Use is contraindicated in the genital area for patients with vaginal discharge; consultation with a doctor is advised. The product should not be used for the treatment of diaper rash without medical guidance. Additionally, the initiation of any other hydrocortisone product should only occur under a doctor's direction. Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare professional. Direct application into the rectum using fingers, mechanical devices, or isopropyl applicators is also contraindicated.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Additionally, patients should refrain from initiating the use of any other hydrocortisone products unless specifically directed by a healthcare professional.

In cases of rectal bleeding, patients must stop using the product and seek medical attention promptly.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients are advised not to initiate the use of any other hydrocortisone product unless directed by a healthcare professional. Rectal bleeding is another critical reason to stop use and seek medical advice.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 consult a doctor before use. For adults and children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age are advised to consult a doctor for the treatment of external anal and genital itching.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, the use of hydrocortisone cream should be carefully considered. Dosage adjustments may be necessary, and it is essential to seek guidance from a healthcare professional regarding appropriate dosing. Special precautions should be taken, and hydrocortisone cream should only be used if clearly needed and under the supervision of a healthcare provider 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.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 these contexts.

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 a Poison Control Center at 1-800-222-1222 if the medication is swallowed.

Patients should be informed to avoid any contact with the eyes, as this may lead to irritation or other complications.

It is important to counsel patients not to exceed the recommended dosage unless specifically directed by a healthcare professional.

Additionally, patients should be cautioned against inserting the medication directly into the rectum using fingers, mechanical devices, or isopropyl applicators, as this could result in adverse effects or complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15°C to 30°C (59°F to 86°F) and must be protected from freezing to maintain its efficacy.

Healthcare professionals are advised to read all label directions prior to use. It is important to retain the carton, as it contains essential information regarding the product.

Additional Clinical Information

Patients should be informed that the medication is administered topically. Clinicians are advised to counsel patients to read all label directions carefully before use and to retain the carton, as it contains important information regarding the medication.

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)