Hydrocortisone

Description

No description information is available for the 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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it 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. There are no teratogenic or nonteratogenic effects associated with this drug.

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 cleanse 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 medication 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 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 due to the potential for exacerbating underlying conditions. It is also contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

Additionally, while using this product, 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 or any mechanical device or applicator is contraindicated to ensure safe usage.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek medical assistance immediately or contact the Poison Control Center at 1-800-222-1222.

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 symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products unless directed by a healthcare provider.

Additionally, patients must seek emergency medical help if rectal bleeding occurs. It is crucial to monitor for these symptoms to ensure patient safety and effective management of their condition.

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 recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a doctor. Rectal bleeding is another serious condition that necessitates immediate medical attention.

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 healthcare professional before use. For children under 12 years of age, it is advised to seek medical guidance for the treatment of external anal and genital itching.

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.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

Lactation

There is no specific information available regarding the use of Hydrocortisone Anti-Itch Cream 1% in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this medication in lactating mothers and breastfed infants have not been established. Healthcare professionals should exercise caution when recommending this product to lactating mothers, considering the lack of data on excretion in breast milk and potential effects on 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 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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable time frame, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

It is imperative to monitor the patient closely for any evolving symptoms and to provide symptomatic treatment as required. Documentation of the incident and any interventions performed should be meticulously recorded for future reference and quality assurance.

In summary, while specific overdosage information is not available, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose situations, ensuring patient safety and optimal outcomes.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222 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. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should consult a doctor for appropriate alternatives.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms clear up and then recur within a few days. It is essential to inform patients not to begin the use of any other hydrocortisone product without first consulting a healthcare professional.

Healthcare providers should emphasize that patients must stop using the product and consult a doctor if rectal bleeding occurs. While using the product, patients should be reminded to avoid contact with their eyes. Furthermore, patients should be instructed not to exceed the recommended dosage unless directed by a doctor and to refrain from 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 room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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)