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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it is indicated for external genital, feminine, and anal itching.

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

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. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of anal itching, it is essential to cleanse the affected area with mild soap and warm water, ensuring a thorough rinse. After cleansing, gently dry the area by patting or blotting with bathroom tissue or a soft cloth before applying the medication.

For children under 12 years of age, consultation with a doctor is recommended before using the product for anal itching.

Contraindications

Use of this product is contraindicated in the following situations:

• Application in the eyes is prohibited due to potential for irritation or damage.

• The product should not be used for diaper rash, as it may not be suitable for this condition.

• It is contraindicated for external genital or feminine itching in patients with vaginal discharge, as this may indicate an underlying condition requiring different treatment.

• Exceeding the recommended daily dosage is not advised unless directed by a healthcare professional, to prevent potential adverse effects.

• The product must not be administered rectally using fingers or any mechanical device or applicator, as this may lead to complications.

Warnings and Precautions

For external use only. This product is not intended for internal application.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional prior to use to ensure safety for both the mother and child.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-888-222-1222 without delay.

Patients should 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. It is important to note that this product, as well as any other hydrocortisone product, should not be used for longer than 7 days. Additionally, if bleeding occurs near the anus while using this product for anal itching, patients should stop use and seek medical advice promptly.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use in the eyes, for diaper rash, and for external genital or feminine itching in the presence of vaginal discharge. Additionally, patients should not exceed the recommended daily dosage unless directed by a healthcare professional, nor should the product be used rectally with fingers or any mechanical device or applicator.

Participants are advised 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. It is important not to use this or any other hydrocortisone product for longer than 7 days. Patients should also seek medical attention if bleeding occurs near the anus when the product is used for anal itching.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-888-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 (anti-pruritic). 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 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. Additionally, for children under 12 years, consultation with a doctor is recommended before using the medication for anal 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-888-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and hives. Skin-related effects noted are skin atrophy, striae, and telangiectasia. Systemic effects, particularly adrenal suppression, have been observed with prolonged use or application over large areas.

Localized infections at the site of application have been reported, along with instances of contact dermatitis and hypopigmentation. Secondary infections and perioral dermatitis have also been documented. Other skin reactions include acneiform eruptions, folliculitis, and a burning or stinging sensation upon application. Additionally, dryness or irritation of the skin, increased hair growth in the area of application, and changes in skin color have been noted. Other unspecified adverse reactions have also been reported.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately. Patients should be instructed to contact a Poison Control Center at 1-888-222-1222 without delay. This information is vital for ensuring prompt and appropriate care in case of an emergency.

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 to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use. In cases of anal itching, it is important to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with bathroom tissue or a soft cloth before application. Additionally, for children under 12 years, a doctor's consultation is recommended before using the product for anal itching.

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)