Hydrocortisone

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations, inflammations, itching, and rashes associated with various conditions, including insect bites, eczema, psoriasis, and reactions to soaps, detergents, cosmetics, jewelry, poison oak, and poison sumac.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use.

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 2 to 4 times daily.

In the case of children under 2 years of age, there is no recommended dosage unless advised and supervised by a physician.

Contraindications

Use is contraindicated in patients with diaper rash; consultation with a healthcare professional is advised. Additionally, the product should not come into contact with the eyes. In the event of contact, it is essential to rinse thoroughly with water.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products unless they have first consulted with a healthcare provider. Additionally, this product is not indicated for use in diaper rash; consultation with a physician is recommended in such cases.

In the event of ingestion, it is crucial to seek emergency medical help or contact the Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. In such cases, patients should discontinue use of this product and refrain from starting any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, this product should not be used for diaper rash unless directed by a doctor.

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 aged 2 years and older may apply the medication to the affected area 2 to 4 times daily. For children under 2 years of age, there is no recommended dosage unless prescribed by a healthcare professional. Caution is advised when administering this medication to infants and toddlers, and it should only be used under medical supervision.

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.

Due to the lack of data, it is advisable to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of therapy.

Pregnancy

There is no information available regarding the use of Hydrocortisone lotion during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

Lactating mothers should consult a doctor before using this product. There is no specific information available regarding the potential for excretion of hydrocortisone lotion in breast milk or the associated risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact the Poison Control Center immediately.

Patients should be informed to stop using the product 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. It is important to emphasize that they should discontinue use of this product and refrain from starting any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, patients should be cautioned against using this product for diaper rash and should seek medical advice in such cases.

While using this product, patients must be advised to avoid contact with the eyes. If contact occurs, they should rinse their eyes thoroughly with water.

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 away from excessive heat or cold to maintain its integrity and efficacy. Prior to use, the product must be shaken well to ensure proper mixing of its components.

Additional Clinical Information

No further data are available.

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)