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 resulting from various conditions. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it is indicated for seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Hydrocortisone USP 1% is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching.

For optimal results, the affected area should be cleaned and dried prior to application. Hydrocortisone USP 1% should be applied topically to the affected area as needed, typically not exceeding four times daily. Care should be taken to avoid contact with the eyes and mucous membranes. The duration of treatment should be limited to the shortest period necessary to achieve the desired therapeutic effect. If symptoms persist or worsen, the patient should be advised to consult a healthcare professional.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

This product should not be applied in the eyes, used for diaper rash, or for external genital or feminine itching in the presence of vaginal discharge. It is imperative that patients do not exceed the recommended daily dosage unless directed by a physician. Additionally, this product should not be administered rectally using fingers or any mechanical device or applicator.

Patients should be instructed to consult a doctor before using this product if they are concurrently using any other hydrocortisone product.

If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients must discontinue use and seek medical advice. It is important to note that this or any other hydrocortisone product should not be used for longer than 7 days. Furthermore, if bleeding occurs due to anal itching, patients should stop use and consult a healthcare professional.

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

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only. Pregnant or breastfeeding individuals are advised to consult a health professional prior to use. The product should not be applied in the eyes, used for diaper rash, or for external genital or feminine itching if there is a vaginal discharge present. Additionally, patients should not exceed the recommended daily dosage unless directed by a healthcare provider. The product should not be administered rectally using fingers or any mechanical device or applicator.

Patients are instructed 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 stop use if bleeding occurs due to anal itching, as continued use of this or any other hydrocortisone product beyond 7 days is not recommended.

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 should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 regarding the potential for overdose with this medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the individual and the circumstances surrounding the event. In cases where an overdose is suspected, it is crucial to monitor the patient closely for any adverse effects that may arise.

Recommended actions in the event of an overdose include immediate assessment of the patient's condition, including vital signs and level of consciousness. Supportive care should be initiated as necessary, and appropriate interventions should be implemented based on the clinical presentation.

Healthcare professionals are advised to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the medication involved. Additionally, reporting any cases of suspected overdose to the appropriate regulatory authorities can contribute to the ongoing safety monitoring of the medication.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and follow established protocols in the event of an overdose scenario.

Nonclinical Toxicology

Pregnant and lactating individuals are advised to consult a healthcare professional prior to the use of this product.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety of children and to address any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in a configuration that ensures safety and efficacy. It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

For optimal storage, the product should be maintained in a secure location, away from direct sunlight and extreme temperatures. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to ensure the integrity of the product. Special handling needs may include avoiding exposure to moisture and ensuring that the product is stored in its original packaging until use.

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)