Hydrocortisone

Description

The drug is identified by SPL Code 34089-3 and 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 several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, iron oxide red, and iron oxide yellow.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, and cosmetics. Additionally, it is indicated for the management of itching related to psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

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 aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external anal itching in adults, it is recommended to clean the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

The use of this product is contraindicated in the following situations:

External feminine itching should not be treated with this product if there is a vaginal discharge; medical consultation is advised. Additionally, the product is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The initiation of any other hydrocortisone product should only occur under the direction of a healthcare provider. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, this product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. Healthcare professionals should advise patients not to initiate the use of any other hydrocortisone product unless specifically directed by a physician.

In cases of external anal itching, patients must adhere strictly to the recommended dosage and should not exceed the directed amount unless instructed by a healthcare provider. Additionally, patients should be cautioned against inserting this product into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications.

Emergency medical assistance should be sought immediately if the product is ingested. Patients or caregivers should contact a Poison Control Center without delay in such instances.

Patients are advised to discontinue use and consult their healthcare provider if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs. Prompt medical consultation is essential in these situations to ensure appropriate management and care.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to monitor symptoms closely; if symptoms persist for more than 7 days, worsen, or if there is a recurrence of symptoms after they have cleared, patients are advised to stop use and consult a doctor. Additionally, any occurrence of rectal bleeding should prompt immediate medical consultation.

While using this product, patients should take care to avoid contact with the eyes. It is also recommended that patients do not initiate the use of any other hydrocortisone product unless specifically directed by a healthcare professional. For those using the product for external anal itching, it is crucial to adhere strictly to the directed dosage and to refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Drug Interactions

The initiation of any additional hydrocortisone product should be undertaken only under the guidance of a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated 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 aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor. In cases of external anal itching, it is advised that children under 12 years of age consult a doctor prior to use.

It is important to keep this medication out of reach of children. If ingested, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information available 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

There is no specific information available regarding the use of Hydrocortisone Ointment 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 on the importance of discussing their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or the potential for excretion of hydrocortisone in breast milk. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

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 the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to document all findings and interventions thoroughly to ensure continuity of care and facilitate further evaluation if required.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, prioritizing patient safety and symptom management.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients experiencing external feminine itching accompanied by vaginal discharge should be instructed to consult a doctor for further evaluation.

For those considering the treatment of diaper rash, it is essential to recommend that they consult a healthcare professional prior to use. Patients should be informed to discontinue use and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve only to reoccur within a few days. Additionally, patients should be cautioned to stop use and consult a doctor promptly if rectal bleeding occurs.

While using this product, patients must be advised to avoid contact with the eyes. It is important to inform patients not to initiate the use of any other hydrocortisone product unless specifically directed by a healthcare provider. For external anal itching, patients should be instructed not to exceed the recommended dosage unless advised by a doctor. Furthermore, patients should be clearly informed not to insert this product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59°F to 86°F (15°C to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the topical medication to the affected area no more than 3 to 4 times daily. For adults experiencing external anal itching, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application. The use of this product is not recommended for children under 2 years of age without consulting a doctor, and children under 12 years of age should also seek medical advice before use.

Clinicians should counsel patients to read all label directions carefully before using the medication and to retain the carton, as it contains important information.

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)