Hydrocortisone

Description

Hydrocortisone 1% Cream is a topical formulation containing hydrocortisone as the active ingredient. The product is identified by the National Drug Code (NDC) 70512-101-30 and is supplied in a quantity of 28.4 grams. This cream is designed for dermatological use, providing anti-inflammatory effects.

Uses and Indications

This drug is indicated for the relief of itching and rashes associated with various dermatological conditions, including eczema, psoriasis, and seborrheic dermatitis. It is also effective for alleviating itching caused by contact with irritants such as poison ivy, poison oak, and poison sumac, as well as insect bites. Additionally, this drug provides temporary relief of external anal itching and genital itching, which may arise from exposure to soaps, detergents, cosmetics, and jewelry.

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 adults and children over 2 years of age, the medication should be applied to the affected area no more than 3 to 4 times per day. Prior to application for external anal itching in adults, it is recommended to cleanse the affected area with mild soap and water, followed by thorough rinsing. The area should then be gently dried by patting with bathroom tissue or a soft cloth before applying the medication.

For children under 2 years of age, the use of this medication is not advised; consultation with a doctor is necessary. Additionally, for children under 12 years of age, it is recommended to consult a doctor before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought or the Poison Control Center contacted.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes, for treating diaper rash, or in the presence of vaginal discharge. It is imperative that users adhere strictly to the recommended dosage; exceeding this dosage may lead to adverse effects.

Healthcare professionals should advise patients to consult a physician prior to use if they are pregnant or breastfeeding. Patients must be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is essential that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

When utilizing this product, it is critical to avoid inserting it into the rectum using fingers or any mechanical device or applicator, as this may result in complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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, or if there is vaginal discharge. Additionally, patients should not exceed the recommended dosage. Prior to use, individuals who are pregnant or breastfeeding should consult a healthcare professional.

In clinical practice, patients are advised to discontinue use and seek medical advice 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 also important to refrain from using any other hydrocortisone products without consulting a doctor.

While using this product, patients must avoid inserting it into the rectum using fingers or any mechanical device or applicator.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone Cream 1%. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the medication to the affected area no more than 3-4 times per day. For children under 2 years of age, the medication is contraindicated, and a healthcare professional should be consulted prior to use. Additionally, for children under 12 years of age, it is recommended to consult a doctor before administration.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider before using this medication. The potential risks and benefits must be carefully considered in these populations. There is limited data available regarding the safety of this medication during pregnancy and lactation, and therefore, healthcare professionals are advised to evaluate the individual circumstances of each patient.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 event of overdosage, the administration of more than the recommended dosage may lead to adverse effects. Healthcare professionals should be vigilant in monitoring patients for potential symptoms associated with overdosage, which can vary depending on the specific medication involved.

Recommended Actions

Upon suspicion of overdosage, it is imperative to assess the patient's clinical status and initiate appropriate management procedures. This may include supportive care and symptomatic treatment as necessary. Healthcare providers should consider contacting a poison control center for guidance on specific interventions and management strategies tailored to the substance involved.

Potential Symptoms

Symptoms of overdosage can manifest in various ways, and their severity may depend on the amount ingested and the individual patient's response. Common symptoms may include, but are not limited to, gastrointestinal disturbances, neurological changes, and cardiovascular effects. Continuous monitoring and evaluation are essential to ensure patient safety and to mitigate any potential complications arising from the overdosage.

In all cases, prompt recognition and intervention are critical to managing the consequences of overdosage effectively.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use due to potential teratogenic effects. In cases where the condition worsens, symptoms persist for more than seven days, or symptoms resolve and then recur within a few days, it is recommended to discontinue use and seek medical advice. Additionally, individuals should refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

No relevant information regarding carcinogenicity, mutagenicity, or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact the Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

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 a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hydrocortisone Cream 1%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)