Hydrocortisone 1%

Description

Hydrocortisone is a corticosteroid with the chemical formula C21H30O5 and a molecular weight of 362.46 g/mol. It is available in various dosage forms, including topical creams, ointments, and injectable solutions. Hydrocortisone appears as a white to off-white crystalline powder, which is odorless and slightly soluble in water. The inactive ingredients may vary depending on the formulation and route of administration.

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external genital and anal areas.

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

Dosage and Administration

When practical, the affected area should be cleansed with mild soap and warm water, followed by thorough rinsing. After cleansing, the area must be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application.

For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, the product is not recommended; consultation with a healthcare professional is advised.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be inserted into the rectum using fingers, mechanical devices, or applicators. In the event of bleeding, the user must discontinue use and consult a healthcare professional immediately. Should the condition worsen, or if symptoms persist for more than 7 days or resolve only to recur within a few days, medical advice should be sought.

Prior to initiating treatment with any other hydrocortisone product, consultation with a healthcare provider is recommended. This product is contraindicated in individuals with vaginal discharge, for the treatment of diaper rash, and in children under 2 years of age. For users addressing external anal itching, it is crucial not to exceed the recommended daily dosage unless directed by a physician.

In cases of bleeding, prompt consultation with a healthcare provider is essential. For children under 12 years of age, a doctor's advice should be obtained before use.

Emergency medical assistance should be sought immediately if the product is ingested, or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes. It is crucial to avoid inserting the product into the rectum using fingers or any mechanical device or applicator. In the event of bleeding, patients are advised to stop using the product and consult a doctor promptly.

If the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, patients should seek medical advice. Prior to using this product, individuals should consult a healthcare professional if they have a vaginal discharge, are treating diaper rash, or are considering its use on children under 2 years of age.

For users treating external anal itching, it is important not to exceed the recommended daily dosage unless directed by a doctor. Additionally, caregivers should consult a doctor before using this product on children under 12 years of age. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not have access to this product, and it must be kept out of their reach. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For the treatment of diaper rash, this product should not be used without consulting a healthcare professional, particularly in children under 2 years of age. For children under 12 years, it is recommended to consult a doctor prior to use.

For adults and children aged 12 years and older, the product may be applied to the affected area no more than 3 to 4 times daily. However, children under 12 years of age should not use this product without prior consultation with a healthcare provider.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns associated with the use of Hydrocortisone 1% ointment as indicated in the provided drug insert. Therefore, standard dosing and administration practices may be applied without modification for this population. However, healthcare providers should continue to monitor elderly patients for any potential adverse effects, as individual responses to treatment may vary.

Pregnancy

There are no specific statements regarding the use of Hydrocortisone 1% ointment during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks and benefits of using this medication in pregnant patients should be carefully considered. Healthcare professionals are advised to evaluate the necessity of treatment with Hydrocortisone 1% ointment in pregnant patients, taking into account the lack of data on its effects during pregnancy. It is recommended that women of childbearing potential discuss their treatment options with their healthcare provider to ensure the best outcomes for both the patient and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breast milk excretion or effects on breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 cases of overdosage, particularly for users experiencing external anal itching, it is crucial to adhere to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare professional.

Healthcare providers should be vigilant for potential symptoms that may arise from overdosage, although specific symptoms were not detailed in the available information. In the event of suspected overdosage, it is recommended that healthcare professionals assess the patient’s condition and provide appropriate management based on clinical judgment.

Monitoring and supportive care may be necessary, and any adverse effects should be documented and reported as per standard medical protocols. It is essential to communicate with the patient regarding the importance of following dosage instructions to prevent the risk of overdosage.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature between 15° and 30°C (59° and 86°F) to maintain its efficacy.

In the event that the seal has been broken, the product should not be used and must be returned to the place of purchase. For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed. Patients are also encouraged to read all label directions carefully and retain the carton, as it contains important information.

Drug Information (PDF)

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

View product document (PDF)