Hydrocortisone Anti-Itch

Description

Hydrocortisone Anti-Itch Cream is a topical formulation designed to alleviate itching and inflammation. The product is presented in a net weight of 0.5 ounces (14 grams).

Uses and Indications

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

Limitations of use include that the product should not be used for more than 7 days unless directed by a healthcare professional. Any other uses or prolonged use beyond this duration should be undertaken only under the advice and supervision of a doctor.

No teratogenic or nonteratogenic effects have been reported.

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 that the affected area be cleaned with mild soap and water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should 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 prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application to the genital area is contraindicated in patients with vaginal discharge due to the potential for exacerbating the condition.

• The product should not be administered rectally using fingers, mechanical devices, or applicators.

• Patients should not exceed the recommended dosage unless directed by a healthcare professional.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted. Rectal bleeding is also a contraindication for use.

Contact with the eyes should be avoided during application.

Warnings and Precautions

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

General precautions include avoiding application in the genital area if there is a vaginal discharge present. For the treatment of diaper rash, consultation with a healthcare professional is recommended prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice 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. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider. Rectal bleeding is another critical reason to stop use and contact a physician immediately.

In cases of ingestion, it is essential to obtain emergency medical help or contact a Poison Control Center right away.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if rectal bleeding occurs. It is advised that patients do not initiate the use of any other hydrocortisone product without first consulting a healthcare professional.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone Anti-Itch (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 for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years, it is advised to consult a doctor prior to use.

In cases of external anal and genital itching, it is recommended that children under 12 years of age also consult a doctor before application.

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

There are no specific statements regarding the use of Hydrocortisone Anti-Itch 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 are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Recommended actions include contacting a poison control center or emergency medical services for guidance on appropriate management strategies. Supportive care should be initiated as necessary, which may involve airway management, intravenous fluids, and symptomatic treatment tailored to the patient's condition.

Healthcare professionals should remain vigilant and consider the possibility of drug interactions or underlying health conditions that may exacerbate the effects of an overdose. Continuous assessment and monitoring of vital signs are crucial in managing the patient's safety and well-being during this critical period.

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 text.

Patient Counseling

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

Patients should be informed not to use the product in the genital area if they have a vaginal discharge. It is important for patients to consult a doctor for the treatment of diaper rash and to ask for guidance regarding its use.

Healthcare providers should counsel patients 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. Patients should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor, especially if rectal bleeding occurs.

While using this product, patients should be cautioned to avoid contact with the eyes. They should not use the product more than directed unless specifically instructed to do so by a doctor. Additionally, 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 a configuration that includes a crimped tube, with the Lot Number and Expiration Date clearly indicated on the crimp of the tube.

It is essential to store the product at a controlled temperature range of 20ºC to 25ºC (68ºF to 77ºF) to ensure its stability and efficacy. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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