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Proctozone-Hc

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Active ingredient
Hydrocortisone 25 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 2015
Label revision date
May 7, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 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 2015
Label revision date
May 7, 2023
Manufacturer
Rising Pharma Holdings, Inc.
Registration number
ANDA040879
NDC root
64980-324
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

Proctozone-HC is a topical cream that contains hydrocortisone (a type of corticosteroid) at a concentration of 2.5%. It is primarily used to relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. Hydrocortisone works by reducing inflammation and suppressing the immune response in the affected area, helping to alleviate discomfort and promote healing.

This cream is designed for application on the skin and is formulated to be easily absorbed. It is particularly effective for treating conditions that cause redness, swelling, and itching, making it a useful option for managing various dermatological issues.

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) or nonteratogenic effects (which refer to other types of harmful effects) associated with these medications. This makes them a safer option for managing your skin concerns.

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 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 treat 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 allergic reactions to any ingredients in topical corticosteroids, you should avoid using them. Additionally, if you experience any irritation while using these medications, stop using them immediately and seek appropriate treatment. It's also important not to use topical corticosteroids if you have a skin infection; instead, you should treat the infection with the right antifungal or antibacterial medication. If you do not see improvement quickly, discontinue the corticosteroid until the infection is properly managed.

Side Effects

You may experience a range of local side effects, including burning, itching, irritation, and dryness at the application site. Other possible reactions are folliculitis (inflammation of hair follicles), acne-like eruptions, and skin changes such as hypopigmentation (lightening of the skin) and atrophy (thinning of the skin). In some cases, allergic reactions like contact dermatitis and secondary infections may occur.

Systemically, this medication can lead to reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which may result in symptoms similar to Cushing’s syndrome, such as increased blood sugar levels (hyperglycemia) and glucose in the urine (glucosuria). Children are particularly vulnerable to these effects, including potential growth issues and increased intracranial pressure, which can manifest as headaches or bulging fontanelles (soft spots on a baby’s head). If you notice signs of steroid withdrawal, you may need additional systemic corticosteroids.

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), symptoms of Cushing’s syndrome (a condition caused by excess cortisol), high blood sugar levels, and sugar in your urine. You should be especially cautious if you are using strong steroids over large areas of your skin, for long periods, or with occlusive dressings (coverings that trap moisture). Children are at a higher risk for these side effects because they may absorb more of the medication.

If you are using a large dose of a potent topical steroid, it’s important to have regular check-ups to monitor your hormone levels through tests like the urinary free cortisol test and the ACTH stimulation test. If you notice any irritation on your skin, stop using the corticosteroid and consult your doctor for appropriate treatment. Additionally, if you have a skin infection, make sure to use the right antifungal or antibacterial medication, and discontinue the corticosteroid until the infection is under control.

Overdose

When you use topical corticosteroids (medications applied to the skin to reduce inflammation), be aware that they can sometimes be absorbed into your body in amounts that may lead to systemic effects (effects that impact the entire body). This means that while these medications are intended for localized treatment, they can occasionally cause side effects that affect your overall health.

If you suspect an overdose, look for signs such as unusual changes in mood, increased blood sugar levels, or other unexpected symptoms. It’s important to seek immediate medical help if you experience severe reactions or if you are unsure about the effects you are experiencing. Always consult your healthcare provider if you have concerns about your medication use or if you notice any unusual symptoms.

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 confirm the safety of topical corticosteroids (those applied to the skin). Therefore, you should only use these medications during pregnancy if your healthcare provider believes the benefits outweigh the risks to your baby. It's also advised to avoid using them extensively, in large amounts, or for long periods while pregnant. Always consult with your doctor before starting or continuing any medication during pregnancy.

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 (taken into the body) corticosteroids are known to be present in breast milk in amounts that are unlikely to harm your infant.

However, it's still wise to be cautious when using topical corticosteroids (those applied directly to the skin) while nursing. Always consult with your healthcare provider to ensure the safety of both you and your baby.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for your child, it's important to be aware that children may be more sensitive to these treatments than adults. This is due to their larger skin surface area relative to their body weight. As a result, there is a risk of serious side effects, such as HPA axis suppression (a disruption in hormone production), Cushing’s syndrome (a condition caused by excess cortisol), and increased pressure in the brain.

To minimize these risks, you should use the smallest amount of the medication necessary to achieve the desired effect. Be vigilant for signs of potential complications, which can include slowed growth, delayed weight gain, low cortisol levels, headaches, and bulging fontanelles (the soft spots on a baby’s head). If you notice any of these symptoms, consult your child's healthcare provider promptly. Chronic use of corticosteroids can affect your child's growth and development, so careful management is essential.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for Proctozone-HC (hydrocortisone 2.5% cream) does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment.

Before using Proctozone-HC, it’s a good idea to discuss your kidney health with your healthcare provider to ensure that this treatment is safe and appropriate for you. They can provide personalized advice based on your individual health needs.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using corticosteroids, as these medications are mainly processed in the liver. Some topical corticosteroids can also affect your body's hormone levels, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which may lead to hormonal imbalances. If you are using a strong topical steroid over a large area of your skin or under a bandage, your doctor may recommend regular tests, such as urinary free cortisol and ACTH stimulation tests, to check for any signs of HPA axis suppression.

Should any issues arise, your healthcare provider might suggest reducing the amount you use, applying it less frequently, or switching to a weaker steroid. Always communicate with your doctor about your liver condition, as it can change how your body processes these medications and may increase the risk of side effects.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are using, especially if you are applying potent topical corticosteroids (a type of anti-inflammatory medication) over large areas of your skin or using them for a long time. These medications can sometimes be absorbed into your body and may lead to issues like hormonal imbalances, high blood sugar, or other health concerns.

If you are using these types of steroids, your doctor may recommend tests, such as the urinary free cortisol test or the ACTH stimulation test, to check how your body is responding. Regular evaluations can help ensure that you stay healthy while using these treatments. Always keep your healthcare provider informed about all medications and treatments you are using to avoid potential interactions and complications.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° and 25° C (68° and 77° F). It’s acceptable for the temperature to occasionally range from 15° to 30° C (59° to 86° F), but try to keep it as close to the recommended range as possible. Always keep the container tightly closed to protect its contents.

For safety, make sure to keep the product out of the reach of children. This will help prevent any accidental misuse or ingestion. Following these guidelines will help you use the product safely and effectively.

Additional Information

You may need to undergo specific laboratory tests if your healthcare provider recommends it. These tests include the urinary free cortisol test, which measures the level of cortisol in your urine, and the ACTH stimulation test, which assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests can help in diagnosing conditions related to hormone levels and adrenal function.

FAQ

What is Proctozone-HC?

Proctozone-HC is a hydrocortisone cream containing 2.5% hydrocortisone, used as a topical corticosteroid for anti-inflammatory and antipruritic effects.

What are the indications for using Proctozone-HC?

Proctozone-HC is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

How should I apply Proctozone-HC?

Apply a thin film of Proctozone-HC to the affected area two to four times daily, depending on the severity of your condition.

Are there any contraindications for Proctozone-HC?

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

What are the possible local adverse reactions?

Local adverse reactions may include burning, itching, irritation, dryness, and acneiform eruptions, among others.

What systemic adverse reactions can occur?

Systemic adverse reactions may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria.

Is Proctozone-HC safe to use during pregnancy?

Proctozone-HC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies on its teratogenic effects.

Can Proctozone-HC be used while breastfeeding?

Caution should be exercised when using Proctozone-HC during breastfeeding, as it is not known if it can be absorbed into breast milk.

What should I do if irritation develops?

If irritation develops, discontinue the use of Proctozone-HC and consult your healthcare provider for appropriate therapy.

How should Proctozone-HC be stored?

Store Proctozone-HC tightly closed at 20° – 25° C (68° – 77° F), and keep it out of the reach of children.

Packaging Info

The table below lists all NDC Code configurations of Proctozone-Hc (hydrocortisone 2.5%), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proctozone-Hc.
Details

FDA Insert (PDF)

This is the full prescribing document for Proctozone-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

Proctozone-HC (Hydrocortisone Cream, USP 2.5%) contains 25 mg of hydrocortisone per gram in a water-washable base composed of purified water, propylene glycol, glyceryl monostearate SE, cholesterol, isopropyl myristate, polysorbate 60, cetyl alcohol, sorbitan monostearate, polyoxyl 40 stearate, sorbic acid, methylparaben, and propylparaben.

Hydrocortisone is chemically defined as Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-, with a molecular formula of C21H30O5 and a molecular weight of 362.46. The CAS Registry Number for hydrocortisone is 50-23-7. This formulation belongs to the class of topical corticosteroids, which are primarily synthetic steroids utilized for their anti-inflammatory and antipruritic properties.

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 medication.

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 the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment. However, if an infection develops during the course of therapy, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should be initiated 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 where irritation develops, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. The presence of dermatological infections necessitates the use of an appropriate antifungal or antibacterial agent. If a favorable response to treatment does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

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 certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, making them more vulnerable to systemic toxicity.

Patients receiving high doses of potent topical corticosteroids, particularly when applied to large areas of the body or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. Recommended laboratory tests for this assessment include the urinary free cortisol test and the ACTH stimulation test.

In cases where irritation occurs, the use of topical corticosteroids should be discontinued immediately, and appropriate alternative therapies should be initiated. Additionally, if dermatological infections are present, it is essential to start treatment with an appropriate antifungal or antibacterial agent. Should there be no prompt improvement in the infection, the corticosteroid treatment must be halted until the infection is adequately managed.

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, dryness, and folliculitis. Other local effects may consist of hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

Systemic adverse reactions, while less frequent, can be serious. These include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

In pediatric patients, there is a noted greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome. Specific manifestations of HPA axis suppression in this population may include intracranial hypertension, which can present as bulging fontanelles, headaches, and bilateral papilledema. Additionally, adrenal suppression may lead to 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, chronic corticosteroid therapy has the potential to interfere with the growth and development of pediatric patients.

Drug Interactions

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.

For patients receiving high doses of potent topical corticosteroids, particularly when applied to large areas of the body or under occlusive dressings, it is recommended that they undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. The urinary free cortisol test and ACTH stimulation test are both useful in monitoring potential HPA axis suppression in these patients.

Packaging & NDC

The table below lists all NDC Code configurations of Proctozone-Hc (hydrocortisone 2.5%), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proctozone-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 HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.

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 adrenocorticotropic hormone (ACTH) stimulation. Additionally, signs 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 consider that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenic effects 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 the necessity of corticosteroid therapy in this population and monitor for any potential effects on fetal development.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Proctozone-HC (hydrocortisone 2.5% cream). Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, caution is warranted when administering topical corticosteroids, as their metabolism may be altered, potentially leading to increased systemic effects. 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. This is particularly concerning for patients with compromised liver function. For patients receiving a large dose of a potent topical steroid applied to extensive areas of the skin or under occlusive dressings, periodic evaluation for evidence of HPA axis suppression is recommended. This can be assessed through urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Overall, careful monitoring and assessment are essential for patients with hepatic impairment to mitigate potential risks associated with altered drug metabolism and systemic absorption of topical corticosteroids.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be aware that overdosage may occur, particularly with prolonged use or application over large surface areas.

In cases of suspected overdosage, it is essential to monitor for potential symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, and other hormonal imbalances.

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. In severe cases, particularly those involving significant systemic absorption, further evaluation and intervention may be necessary. Healthcare providers should consider consulting a poison control center or a specialist in toxicology for guidance on specific management strategies tailored to the individual patient's needs.

Regular assessment and monitoring of the patient's clinical status are crucial to mitigate any adverse effects resulting from overdosage.

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

Local adverse reactions associated with topical corticosteroids have been reported infrequently, with an increased occurrence noted when occlusive dressings are used. 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.

Systemic absorption of topical corticosteroids has been linked to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. In pediatric populations, reports have indicated HPA axis suppression, Cushing’s syndrome, and intracranial hypertension following the use of topical corticosteroids. Manifestations of adrenal suppression in these patients 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.

Additionally, infrequent cases of steroid withdrawal symptoms have been observed, which may necessitate the administration of supplemental systemic corticosteroids.

For reporting suspected adverse reactions, healthcare professionals are encouraged to contact Rising Pharmaceuticals, Inc. at 1-844-874-7464 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Patient Counseling

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

It is essential for patients to understand that this medication should not be used for any condition other than the specific disorder for which it was prescribed. Healthcare providers should emphasize the importance of adhering to this guidance to ensure safety and efficacy.

Patients should also be advised 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 reactions.

In addition, patients must be encouraged to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing. Prompt reporting can facilitate timely management of any issues that may arise.

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

Storage and Handling

The product is supplied in a tightly closed container to ensure integrity and stability. It should be stored at a temperature range of 20° to 25° C (68° to 77° F), with excursions permitted between 15° and 30° C (59° and 86° F) in accordance with USP Controlled Room Temperature guidelines. Additionally, it is essential to keep the product out of the reach of children to ensure safety.

Additional Clinical Information

Patients may undergo specific laboratory tests to assess their condition, including the urinary free cortisol test and the ACTH stimulation test. These tests are essential for clinicians to evaluate adrenal function and diagnose related disorders effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Proctozone-Hc as submitted by Rising Pharma Holdings, 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 Proctozone-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 (ANDA040879) 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.

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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.