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Procto-Med Hc

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This product has been discontinued

Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
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 2016
Label revision date
December 12, 2017
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
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 2016
Label revision date
December 12, 2017
Manufacturer
Leading Pharma, LLC
Registration number
ANDA089682
NDC root
69315-302
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 is a topical corticosteroid, which means it is a type of synthetic steroid used to reduce inflammation and relieve itching. It contains hydrocortisone, a compound that works by decreasing the immune response in the skin, helping to alleviate symptoms associated with various skin conditions. This cream is commonly used to treat inflammatory and itchy skin disorders that respond to corticosteroids.

When applied to the skin, hydrocortisone cream can be absorbed and acts similarly to corticosteroids taken by mouth or injected. It is effective for conditions that cause redness, swelling, and discomfort, providing relief from these symptoms.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. If you are experiencing skin issues that cause discomfort, these medications can provide relief from symptoms like redness and irritation.

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) associated with these medications, making them a safer option for many individuals. Always consult with your healthcare provider to determine the best treatment for your specific skin condition.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. This should be done 2 to 4 times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you might use occlusive dressings (coverings that keep the medication in place) to enhance the treatment's effectiveness.

However, if you notice any signs of infection, it's important to stop using the occlusive dressings immediately. In such cases, you should seek appropriate antimicrobial therapy (medications that fight infections) to address the infection before continuing with your treatment. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (an extreme allergic reaction) to any of the ingredients in topical corticosteroids, you should avoid using these medications. It's important to be aware that using these products when you have such a history can lead to serious allergic reactions.

Additionally, be cautious with the potential for misuse or abuse of topical corticosteroids, as they are classified as controlled substances. This means they should be used only as directed by your healthcare provider to prevent dependence (a condition where your body becomes reliant on a substance) and other complications. Always follow your doctor's instructions and discuss any concerns you may have about your treatment.

Side Effects

You may experience some local side effects when using this medication, including burning, itching, irritation, and dryness of the skin. Other possible reactions are folliculitis (inflammation of hair follicles), acne-like eruptions, and changes in skin color. In some cases, you might also notice skin thinning, stretch marks, or secondary infections.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing’s syndrome, which can cause weight gain and other symptoms, as well as increased blood sugar levels. If you are using this medication for children, be aware that they may be more prone to these effects, including growth delays and increased pressure in the brain, which can manifest as headaches or bulging fontanelles (the soft spots on a baby’s head). Additionally, signs of steroid withdrawal may occur, and children may absorb more of the medication, increasing the risk of side effects.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. While there are no specific warnings listed, you should consider having laboratory tests to evaluate your body's hormone production, particularly tests like the urinary free cortisol test and the ACTH stimulation test. These can help assess the function of your hypothalamic-pituitary-adrenal (HPA) axis, which is crucial for your body's response to stress.

If you experience any unusual symptoms or have concerns while taking this medication, it's advisable to stop using it and consult your doctor for further guidance. Always prioritize your health and communicate openly with your healthcare provider about any changes you notice.

Overdose

Using topical corticosteroids (medications applied to the skin to reduce inflammation) can sometimes lead to absorption into your body, which may cause effects beyond the skin. This means that while these medications are intended for local treatment, they can occasionally enter your bloodstream and affect other parts of your body.

If you suspect an overdose, look for signs such as unusual changes in mood, increased appetite, or swelling. It’s important to seek immediate medical help if you experience severe symptoms or if you have concerns about how the medication is affecting you. Always consult your healthcare provider if you have questions about the use of topical corticosteroids or if you think you may have used too much.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with corticosteroids, which are a type of medication often used to reduce inflammation. These medications are classified as Pregnancy Category C, meaning that while they may be necessary in some cases, they have shown potential risks in animal studies, including teratogenic effects (which can cause developmental issues in the fetus).

Currently, there are no well-controlled studies in pregnant women to fully understand the risks associated with using topical corticosteroids. Therefore, you should only use these medications during pregnancy if your healthcare provider believes the benefits outweigh the potential risks to your baby. It's also advised to avoid using large amounts or applying them extensively or for long periods while pregnant. Always consult with your healthcare provider before starting or continuing any medication during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while systemically administered corticosteroids (those taken by mouth or injection) do appear in breast milk, the amounts are generally not expected to harm your baby. However, when it comes to topical corticosteroids (those applied directly to the skin), it is unclear whether enough of the medication can be absorbed into your bloodstream to affect your breast milk.

Given this uncertainty, it's best to be cautious when using topical corticosteroids while nursing. Always consult with your healthcare provider to discuss the safest options for 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), Cushing’s syndrome (a hormonal disorder), and increased pressure in the brain. Signs of these issues can include slowed growth, delayed weight gain, low hormone levels, headaches, and swelling in the eyes.

To minimize risks, you should use the smallest amount of topical corticosteroids necessary to effectively treat your child's condition. Long-term use of these medications can also affect a child's growth and development, so it's crucial to follow your healthcare provider's guidance closely.

Geriatric Use

As you age, your body may respond differently to medications, including topical corticosteroids. Older adults can be more sensitive to the side effects of these treatments, so it's important to use them with caution. While there are no specific dosage changes recommended for seniors, you should be aware that the risk of side effects, such as HPA axis suppression (a condition where the body’s hormone production is affected), may be higher.

If you or a loved one is using large amounts of topical corticosteroids or wearing occlusive dressings (which cover the skin), regular check-ups are advised to monitor for any signs of HPA axis suppression. Additionally, keep in mind that older adults may have reduced kidney function, which can influence how the body processes these medications. Always consult with a healthcare provider to ensure safe and effective use.

Renal Impairment

If you have kidney issues, it's important to be cautious when using topical corticosteroids, as these medications are processed mainly in the liver and excreted by the kidneys. Some of these steroids can also enter the bile. Because of this, there is a risk of systemic absorption, which can lead to a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression. This means your body may not produce enough of certain hormones, and monitoring may be necessary.

If you are using a strong topical steroid over a large area of skin or under a bandage, your healthcare provider may recommend regular checks for HPA axis suppression. This can be done through tests that measure cortisol levels in your urine and assess your adrenal function. If any suppression is detected, your doctor may suggest reducing the amount you use, applying it less often, or switching to a weaker steroid. Generally, your hormone levels should return to normal quickly after stopping the medication, but in rare cases, you might experience withdrawal symptoms that could require additional treatment with systemic corticosteroids. Always discuss any concerns with your healthcare provider to ensure safe use of these medications.

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 bile, which is produced by the liver. If you are using a strong topical steroid over a large area of your skin or under a covering, your doctor may need to monitor your hormone levels to check for a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression. This can be done through specific tests that measure cortisol levels in your urine and how your body responds to stimulation.

If signs of HPA axis suppression are detected, your healthcare provider may suggest reducing the amount of the steroid you use, changing to a less potent option, 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 while using these medications.

Drug Interactions

It's important to be aware that certain conditions can increase how much of a medication your body absorbs, especially when using strong topical steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). This can lead to potential side effects, so discussing your medication use with your healthcare provider is crucial.

If you're using a potent topical steroid in these ways, your doctor may recommend regular check-ups to monitor your body's hormone levels. Tests like the urinary free cortisol test and the ACTH stimulation test can help assess if your body's hormone production is being affected. Always keep an open line of communication with your healthcare provider about any medications or tests to ensure your safety and well-being.

Storage and Handling

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

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

Additional Information

If you're concerned about the effects of a medication on your body's hormone regulation, specific laboratory tests can help. The urinary free cortisol test and the ACTH (adrenocorticotropic hormone) stimulation test are useful for assessing whether your hypothalamic-pituitary-adrenal (HPA) axis is being suppressed. These tests can provide important insights into how your body is responding to treatment. If you have questions about these tests or their implications, be sure to discuss them with your healthcare provider.

FAQ

What is hydrocortisone cream?

Hydrocortisone cream is a topical corticosteroid used as an anti-inflammatory and anti-pruritic agent.

How should I use hydrocortisone cream?

Apply a thin film of hydrocortisone cream to the affected area 2 to 4 times daily, depending on the severity of your condition.

What are the common side effects of hydrocortisone cream?

Common local side effects include burning, itching, irritation, dryness, and skin atrophy. Systemic effects may include reversible HPA axis suppression and hyperglycemia.

Are there any contraindications for using hydrocortisone cream?

Yes, it is contraindicated in patients with a history of hypersensitivity to any of its components.

Can hydrocortisone cream be used during pregnancy?

Hydrocortisone cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

What should I do if I develop an infection while using hydrocortisone cream?

If an infection develops, discontinue the use of occlusive dressings and seek appropriate antimicrobial therapy.

What precautions should I take when using hydrocortisone cream on children?

Use the least amount necessary for effective treatment, as children may absorb larger amounts and be more susceptible to systemic effects.

How should hydrocortisone cream be stored?

Store hydrocortisone cream at controlled room temperature between 15°-30°C (59°-86°F) and do not freeze.

Packaging Info

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

Packaging configurations for Procto-Med Hc.
Details

FDA Insert (PDF)

This is the full prescribing document for Procto-Med Hc, 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 cream is a topical formulation belonging to the class of synthetic corticosteroids, utilized for their anti-inflammatory and anti-pruritic properties. The active ingredient, hydrocortisone, is chemically designated as Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-, with a molecular formula of C21H30O5 and a molecular weight of 362.46. The cream contains 2.5% hydrocortisone, providing 25 mg of the active ingredient per gram.

The cream base comprises cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, and citric acid solution, along with sodium citrate solution for pH adjustment.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of 2 to 4 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. Use in these individuals may lead to severe allergic reactions or exacerbation of existing conditions.

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of the medication.

Evaluation of the Hypothalamic-Pituitary-Adrenal (HPA) Axis

Monitoring the function of the HPA axis is crucial in patients receiving this treatment. The following laboratory tests are recommended to assess potential HPA axis suppression:

  • Urinary Free Cortisol Test: This test measures the level of cortisol in the urine and can provide insight into adrenal function.

  • ACTH Stimulation Test: This test evaluates the adrenal glands' response to adrenocorticotropic hormone (ACTH) and is useful in determining the integrity of the HPA axis.

Healthcare professionals should consider these tests when evaluating patients for potential HPA axis suppression to ensure appropriate management and intervention.

Side Effects

Patients may experience a range of local and systemic adverse reactions associated with the use of this medication.

Local adverse reactions are commonly reported and include burning, itching, irritation, and dryness of the skin. Other local effects may consist of folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

Systemic effects, although less frequent, can occur and include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

In pediatric populations, there is an increased risk of HPA axis suppression and Cushing’s syndrome. Additionally, children may experience intracranial hypertension, which can manifest as bulging fontanelles, headaches, and bilateral papilledema. Signs 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.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Furthermore, children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Drug Interactions

Conditions that enhance systemic absorption of topical steroids include the use of more potent formulations, application over extensive surface areas, prolonged usage, and the incorporation of occlusive dressings.

Patients who are administered a high dose of a potent topical steroid, particularly when applied to large areas of the skin or under occlusive dressings, should undergo regular evaluations for potential hypothalamic-pituitary-adrenal (HPA) axis suppression. Recommended assessments include the urinary free cortisol test and the ACTH stimulation test to monitor for signs of HPA axis suppression.

Packaging & NDC

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

Packaging configurations for Procto-Med Hc.
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 mature patients, 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.

Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to 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. It is important to note that chronic corticosteroid therapy may adversely affect the growth and development of children.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of topical corticosteroids. While there are no specific dosage adjustments recommended for this population, caution is advised due to the potential for heightened sensitivity.

Systemic absorption of topical corticosteroids can result in adverse effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression, which may be more pronounced in geriatric patients. Therefore, periodic evaluation for evidence of HPA axis suppression is recommended for patients receiving large doses or utilizing occlusive dressings, including those in the elderly demographic.

Additionally, it is important to consider that elderly patients may have reduced kidney function, which could impact the metabolism and excretion of corticosteroids. Healthcare providers should monitor these patients closely to ensure safe and effective use of topical corticosteroids.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated teratogenic effects associated with systemic administration of corticosteroids at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenicity following dermal application in laboratory animals. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only when the anticipated benefits outweigh the potential risks to the fetus. It is advised that these medications not be used extensively, in large amounts, or for prolonged periods in pregnant patients to minimize any potential adverse fetal outcomes. Healthcare professionals should carefully consider these factors when prescribing corticosteroids to women of childbearing potential.

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

Topical corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys, with some metabolites also eliminated via bile. In patients with renal impairment, systemic absorption of these corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

Patients receiving large doses of potent topical steroids, particularly when applied to extensive areas of skin 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 medication, reducing the frequency of application, or substituting a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which could necessitate the administration of supplemental systemic corticosteroids. Therefore, caution is warranted when administering topical corticosteroids to patients with renal impairment due to the potential for systemic absorption and associated effects.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, the metabolism and clearance of corticosteroids may be affected, necessitating careful consideration of dosing and monitoring.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with compromised liver function who are receiving large doses of potent topical steroids, especially when applied to extensive areas of the skin 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.

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. Regular monitoring and appropriate adjustments in therapy are essential to ensure the safety and efficacy of treatment in patients with hepatic impairment.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in amounts sufficient to elicit systemic effects. Healthcare professionals should be aware of this possibility when prescribing or recommending these medications.

In the event of overdosage, it is crucial to monitor for potential systemic effects that may arise from excessive use. Symptoms of systemic corticosteroid overdosage can include, but are not limited to, adrenal suppression, Cushing's syndrome, and other related endocrine disorders.

Management of overdosage should focus on the immediate assessment of the patient's clinical status. If systemic effects are suspected, appropriate interventions may include discontinuation of the corticosteroid and supportive care tailored to the symptoms presented. In cases of significant adverse effects, referral to a specialist may be warranted for further evaluation and management.

Healthcare professionals are advised to consult relevant guidelines and literature for specific management protocols and to report any adverse events associated with corticosteroid overdosage to the appropriate regulatory authorities.

Nonclinical Toxicology

Corticosteroids are classified as Pregnancy Category C, indicating that they are generally 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 regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be limited to situations where the potential benefits outweigh the risks to the fetus. It is advised that drugs within this class not be used extensively, in large amounts, or for prolonged periods in pregnant patients.

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility associated with topical corticosteroids.

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 glucosuria in some patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over large surface areas, prolonged treatment duration, and the use of occlusive dressings.

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

Local adverse reactions associated with topical corticosteroids have been reported infrequently; however, their occurrence may be more prevalent 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.

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 patients to understand that this medication should not be used for any condition other than the one for which it was prescribed. Providers should emphasize the necessity of following the prescribed treatment plan closely.

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. This is crucial to prevent potential adverse effects.

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

For parents of pediatric patients, it is essential to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. Such garments may act as occlusive dressings, which could lead to increased risk of adverse reactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific laboratory tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test as part of the assessment process. These tests can provide valuable insights into the functioning of the HPA axis.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Procto-Med Hc as submitted by Leading Pharma, LLC. 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 Procto-Med Hc, 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 (ANDA089682) 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.