Hydrocortisone

Description

The product is identified by SPL Code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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, and contact with plants such as poison ivy, poison oak, or poison sumac. Additionally, it is effective for reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

For other potential uses of this product, healthcare professionals are advised to consult a physician.

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

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. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used for the treatment of diaper rash. Healthcare professionals are advised to instruct patients to consult a physician prior to use if they are concurrently using any other hydrocortisone products.

Patients should be closely monitored for any signs of worsening conditions or persistent symptoms. If the condition does not improve or if symptoms persist beyond 7 days, it is imperative to discontinue use and seek medical advice. Additionally, if symptoms resolve and then recur within a few days, patients should also stop using the product and consult a healthcare provider.

It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

In summary, patients should be advised to stop using the product and contact their healthcare provider if they experience any worsening of their condition or if symptoms persist for more than 7 days.

Side Effects

Patients should be aware that the product is for external use only and should not be applied in the eyes or used for the treatment of diaper rash.

In clinical practice, it is advised that patients consult a doctor before using this product if they are concurrently using any other hydrocortisone product.

Patients are also 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.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

Concurrent use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult a healthcare professional prior to initiating treatment with hydrocortisone if they are currently using any other hydrocortisone formulations. This is to prevent potential additive effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

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 kept out of reach of children. In the event of accidental ingestion, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. However, the use of this product is not recommended for children under 2 years of age; consultation with a healthcare professional is necessary before use in this age group.

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

The safety of this product during pregnancy has not been established, and it is contraindicated for use in pregnant patients. Women who are pregnant or planning to become pregnant should consult their healthcare provider prior to using this product to discuss potential risks and alternative options. It is essential to evaluate the benefits and risks in the context of individual patient circumstances.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical guidance are vital in managing cases of overdosage effectively.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of 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 room temperature, ensuring that it is protected from freezing and excessive heat to maintain its integrity. For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube. Proper handling and storage conditions are essential to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, it is advised to consult a doctor before use. 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)