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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
July 1, 2020
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
July 1, 2020
Manufacturer
Actavis Pharma, Inc.
Registration number
ANDA087795
NDC root
0472-0321
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone Cream, USP 1% is a topical corticosteroid, which means it is a type of synthetic steroid used to reduce inflammation and relieve itching. This cream contains hydrocortisone, a substance that helps manage skin conditions that respond to corticosteroids, such as rashes or other inflammatory skin issues. Each gram of the cream provides 10 mg of hydrocortisone in a water-washable base, making it easy to apply to the skin.

You can use Hydrocortisone Cream to help alleviate the discomfort associated with various skin conditions. It works by targeting the underlying inflammation and itching, providing you with relief from these symptoms. Remember, this cream is intended for external use only and should not be applied to the eyes.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. These conditions, known as corticosteroid-responsive dermatoses, can cause discomfort and irritation, and using these medications can provide significant relief.

It's important to note that the information provided does not mention any teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects, meaning that there are no known risks of these types associated with the use of topical corticosteroids. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. Depending on how severe your condition is, you may need to do this two to four times a day. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in contact with the skin) to enhance the treatment's effectiveness.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. In that case, it's important to seek appropriate antimicrobial therapy (medications that treat infections) to address the infection properly. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any of the ingredients in topical corticosteroids, you should avoid using these medications. Additionally, if you experience irritation while using a topical corticosteroid, stop using it immediately and seek appropriate treatment.

It's also important to note that if you have a skin infection, you should use the right antifungal or antibacterial treatment first. Do not continue using the corticosteroid until the infection is properly managed and you see improvement.

Side Effects

You may experience some local side effects when using topical corticosteroids, including burning, itching, irritation, and dryness of the skin. Other possible reactions are folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acne-like eruptions, and changes in skin color. In some cases, you might also notice skin thinning, stretch marks, or secondary infections. If you develop irritation, it's important to stop using the product and seek appropriate treatment.

There are also general precautions to consider. Using topical corticosteroids can lead to systemic absorption, which may cause issues like adrenal suppression, Cushing’s syndrome (a hormonal disorder), and elevated blood sugar levels. In children, these medications can result in growth delays and other serious conditions, such as increased pressure in the brain. If you notice any concerning symptoms, consult your healthcare provider for guidance.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including potential suppression of your body's hormone production (known as HPA axis suppression), which can cause symptoms like Cushing’s syndrome, high blood sugar, and sugar in your urine. This risk increases if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don’t see improvement quickly.

If you are using a strong topical steroid on a large area or under a dressing, your doctor may want to check your hormone levels periodically with tests like the urinary free cortisol test or the ACTH stimulation test. If these tests show signs of hormone suppression, your doctor may suggest reducing the steroid use or switching to a less potent option. Children are particularly at risk for systemic side effects, so extra caution is advised.

While there are no specific emergency instructions provided, it’s always best to consult your doctor if you have concerns or experience unusual symptoms. If you need to stop using the medication, reach out to your healthcare provider for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Corticosteroids, a type of medication often used to reduce inflammation, may pose risks during pregnancy. Studies in laboratory animals have shown that these drugs can cause birth defects (teratogenic effects) even at low doses when given systemically. Additionally, more potent corticosteroids have been linked to similar risks when applied to the skin. However, there are no well-controlled studies in pregnant women to confirm these effects from topical (skin-applied) corticosteroids.

Because of these concerns, it is important to use topical corticosteroids during pregnancy only if the potential benefits outweigh the risks to your baby. You should avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

When using corticosteroids while breastfeeding, it's important to be aware of how they may affect you and your baby. While it is unclear if applying corticosteroids to the skin can lead to enough absorption into your bloodstream to appear in breast milk, systemic (whole-body) corticosteroids are known to pass into breast milk in amounts that are unlikely to harm your infant.

However, it's wise to be cautious with topical corticosteroids (those applied directly to the skin) while nursing. If you have concerns or questions about using these medications, consider discussing them with your healthcare provider to ensure the best care for both you and your baby.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for children, it's important to be aware that they may be more sensitive to side effects than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious conditions like adrenal suppression (a decrease in hormone production) and Cushing’s syndrome (a hormonal disorder), as well as increased pressure in the brain.

To minimize risks, you should use the smallest amount of the medication necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby’s head). Long-term use of these medications can affect your child's growth and development, so regular check-ups with your healthcare provider are essential.

Geriatric Use

As you age, your skin may become more sensitive to medications, including topical corticosteroids. This means that older adults might experience stronger effects from these treatments due to natural changes in skin integrity and function. While there are no specific dosage adjustments needed for older patients, it's important for healthcare providers to be cautious when prescribing these medications.

Elderly individuals may also be more prone to side effects, so careful monitoring for any adverse reactions is essential. If you or a loved one is using a high dose of a topical corticosteroid or applying it under occlusive dressings (which cover the skin), regular check-ups are recommended to ensure that the body's hormone levels remain stable and to avoid potential complications.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are primarily processed in the liver and then excreted by the kidneys. Some of these medications can also affect your hormone levels, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which may need monitoring if you have renal impairment.

If you are using a strong topical corticosteroid over a large area of your skin or under a covering, your doctor may recommend regular checks for HPA axis suppression. This can be done through tests that measure cortisol levels in your urine and how your body responds to stimulation. If any suppression is detected, your healthcare provider may suggest reducing the medication, changing to a less potent steroid, or stopping it altogether. Fortunately, most people recover quickly and completely from any hormonal changes once the corticosteroid is discontinued, although some may experience withdrawal symptoms that could require additional treatment.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed by your kidneys. Some topical corticosteroids can also be found in your bile. If you use a strong topical steroid over a large area of your skin or under a covering, your doctor may need to monitor your hormone levels, specifically looking for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression. This can be done through tests that measure cortisol levels in your urine and how your body responds to stimulation.

If any suppression is detected, your healthcare provider may suggest reducing the amount of the steroid you use, changing to a weaker one, or stopping the medication altogether. The good news is that if you stop using the corticosteroid, your hormone levels usually return to normal quickly. Always consult your doctor for personalized advice and monitoring if you have liver issues.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any additional instructions provided with the product for optimal use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines included with your product.

Additional Information

If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. The urinary free cortisol test measures the level of cortisol in your urine, which can indicate how well your adrenal glands are working. Another useful test is the ACTH stimulation test, which assesses how your body responds to adrenocorticotropic hormone (ACTH), a hormone that stimulates cortisol production.

If you have any questions about these tests or their implications, it's a good idea to discuss them with your healthcare provider.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream, USP 1% is a topical corticosteroid indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Cream?

You should apply a thin film of Hydrocortisone Cream to the affected area two to four times daily, depending on the severity of your condition.

Are there any contraindications for using Hydrocortisone Cream?

Yes, you should not use Hydrocortisone Cream if you have a history of hypersensitivity to any of its components.

What are some common side effects of Hydrocortisone Cream?

Common local adverse reactions may include burning, itching, irritation, dryness, and folliculitis. If irritation develops, discontinue use and consult your doctor.

Can I use Hydrocortisone Cream if I am pregnant?

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies on teratogenic effects in pregnant women.

Is Hydrocortisone Cream safe for children?

Caution is advised when using Hydrocortisone Cream in children, as they may be more susceptible to systemic effects like HPA axis suppression and Cushing’s syndrome.

What should I do if I develop a skin infection while using Hydrocortisone Cream?

If a skin infection develops, discontinue the use of Hydrocortisone Cream and initiate appropriate antimicrobial therapy.

How should I store Hydrocortisone Cream?

Store Hydrocortisone Cream at controlled room temperature between 15° to 30°C (59° to 86°F) and avoid freezing.

Packaging Info

The table below lists all NDC Code configurations of Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

FDA Insert (PDF)

This is the full prescribing document for Hydrocortisone, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Hydrocortisone, USP is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)-. Its molecular formula is C21H30O5, and it has a molecular weight of 362.46 g/mol. Each gram of Hydrocortisone Cream USP, 1% contains 10 mg of hydrocortisone, USP, formulated in a non-staining water washable cream base. The cream base is composed of stearyl alcohol, glyceryl monostearate, polyoxyl 40 stearate, isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic acid, potassium sorbate, and purified water.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These conditions may include a variety of skin disorders that respond positively to corticosteroid treatment.

There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with the frequency of application ranging from two to four times daily, depending on the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment.

In cases where an infection develops, it is imperative to discontinue the use of occlusive dressings immediately and to initiate appropriate antimicrobial therapy to address the infection.

Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

In cases of irritation, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, in the presence of dermatological infections, it is essential to use an appropriate antifungal or antibacterial agent. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the application of occlusive dressings. In cases where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate alternative therapy should be initiated.

In patients with dermatological infections, it is essential to administer an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid should be discontinued until the infection is adequately controlled.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. Should HPA axis suppression be detected, it is advisable to withdraw the corticosteroid, reduce the frequency of application, or consider substituting a less potent steroid. Recovery of HPA axis function typically occurs rapidly and completely upon discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may arise, necessitating the use of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, making them more susceptible to systemic toxicity. Therefore, careful monitoring and consideration of dosage are crucial in this population.

For monitoring purposes, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test.

Side Effects

Patients using topical corticosteroids may experience a range of local adverse reactions. Commonly reported reactions include burning, itching, irritation, and dryness of the skin. Other local effects may include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

Serious adverse reactions associated with systemic absorption of topical corticosteroids have been noted, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria. Patients may also experience signs and symptoms of steroid withdrawal, which may necessitate the administration of supplemental systemic corticosteroids.

In pediatric populations, the use of topical corticosteroids has been linked to HPA axis suppression, Cushing’s syndrome, and intracranial hypertension. Manifestations of adrenal suppression in children may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension can present as bulging fontanelles, headaches, and bilateral papilledema.

If patients develop irritation, it is recommended that topical corticosteroids be discontinued and appropriate therapy initiated. In cases where dermatological infections are present, the use of an appropriate antifungal or antibacterial agent should be considered. Should a favorable response not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome compared to adults, primarily due to a larger skin surface area relative to body weight. Reports indicate that children receiving topical corticosteroids have experienced HPA axis suppression, Cushing’s syndrome, and intracranial hypertension.

In children, manifestations of adrenal suppression can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to adrenocorticotropic hormone (ACTH) stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

To mitigate these risks, the administration of topical corticosteroids in pediatric patients should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. Additionally, chronic corticosteroid therapy may adversely affect the growth and development of children.

Geriatric Use

Elderly patients may exhibit increased susceptibility to the systemic effects of topical corticosteroids, attributed to age-related changes in skin integrity and function. While there are no specific dosage adjustments recommended for this population, caution is advised when prescribing these medications to geriatric patients.

Increased sensitivity to side effects may occur in elderly patients, necessitating careful monitoring for adverse reactions. It is important for healthcare providers to conduct periodic evaluations for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly in patients receiving large doses or utilizing occlusive dressings. This vigilance is essential to ensure the safety and well-being of geriatric patients undergoing treatment.

Pregnancy

Corticosteroids are generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. However, there are no adequate and well-controlled studies in pregnant women that specifically evaluate the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only if the anticipated benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.

Caution should be exercised when topical corticosteroids are administered to lactating mothers.

Renal Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with renal impairment, systemic absorption of topical corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

Patients receiving large doses of potent topical steroids, especially when applied to extensive areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare cases, signs and symptoms of steroid withdrawal may manifest, which may require the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, the metabolism and excretion of corticosteroids may be affected, necessitating careful consideration of treatment regimens. Some topical corticosteroids and their metabolites are also excreted into the bile, which may further complicate their use in this population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with hepatic impairment who are receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, should be monitored periodically for signs of HPA axis suppression. This monitoring can be conducted using urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider substituting a less potent steroid. It is important to note that recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events related to overdosage to the appropriate regulatory authorities.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in pediatric patients receiving topical corticosteroids. In children, manifestations of adrenal suppression may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions associated with topical corticosteroids have been reported infrequently, though they may occur more frequently with the use of occlusive dressings. These reactions include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

For the reporting of suspected adverse events, individuals are encouraged to contact Actavis at 1-888-838-2872 or the FDA at 1-800-FDA-1088, or visit http://www.fda.gov/ for voluntary reporting of adverse reactions.

Patient Counseling

Healthcare providers should advise patients that this medication is to be used strictly as directed by their physician and is intended for external use only. Patients must be cautioned to avoid contact with the eyes to prevent irritation or injury.

It is important for healthcare providers to emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. Additionally, patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.

Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for reevaluation of the treatment plan.

For pediatric patients, healthcare providers should counsel parents to avoid using tight-fitting diapers or plastic pants on children being treated in the diaper area, as these garments may act as occlusive dressings and could exacerbate any potential adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Care must be taken to avoid freezing, as this may compromise the integrity of the product. Proper container requirements should be adhered to, ensuring that the product is kept in an appropriate environment to maintain its efficacy. Special handling needs should be observed to ensure optimal storage conditions are met.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Actavis Pharma, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA087795) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.