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Anusol

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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 1984
Label revision date
June 1, 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 1984
Label revision date
June 1, 2023
Manufacturer
Salix Pharmaceuticals, Inc
Registration number
ANDA088250
NDC root
65649-401
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

Anusol-HC® 2.5% is a topical cream that contains hydrocortisone (a type of corticosteroid) as its active ingredient. This medication is primarily used to relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. The cream is designed for external use and works by reducing inflammation and irritation in the affected area.

Hydrocortisone, the key component of Anusol-HC, is absorbed through the skin and acts similarly to corticosteroids that are taken systemically. It helps to alleviate symptoms by targeting the underlying inflammation, making it effective for treating various skin issues.

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

You should apply Anusol-HC 2.5% (hydrocortisone cream) to the affected area two to four times a day, depending on how severe your condition is. This cream helps reduce inflammation and discomfort.

If you are managing psoriasis or other stubborn skin conditions, you can use occlusive dressings (coverings that keep the cream in place and enhance its effectiveness). However, if you notice any signs of infection, such as increased redness or pus, stop using the occlusive dressings immediately and consult your healthcare provider for appropriate antimicrobial (infection-fighting) treatment.

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 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. Always prioritize your health and consult with a healthcare professional if you have any concerns.

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, changes in skin color (hypopigmentation), and conditions like perioral dermatitis (skin irritation around the mouth). Additionally, you might notice skin thinning (atrophy), maceration (softening of the skin), increased hair growth (hypertrichosis), allergic reactions, or secondary infections.

It's important to be aware that using topical corticosteroids can sometimes lead to more serious effects, such as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can cause symptoms similar to Cushing’s syndrome (a hormonal disorder), high blood sugar, and glucosuria (sugar in urine). In children, there is a higher risk of these effects, including growth delays and signs of increased pressure in the brain, such as headaches and bulging fontanelles (soft spots on a baby's head). If you notice any concerning symptoms, please consult your healthcare provider.

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 similar to Cushing’s syndrome, high blood sugar levels, and sugar in your urine. These risks can increase if you use stronger steroids, apply them over large areas of skin, use them for a long time, or cover them with occlusive dressings (like bandages). 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 until the infection is under control.

It's important to monitor your health while using these medications. If tests show signs of HPA axis suppression, you may need to reduce how often you apply the drug or stop using it altogether. Most people recover quickly and completely after discontinuing the medication, but some may experience withdrawal symptoms that require additional treatment. Be aware that children may absorb more of the medication and could be at a higher risk for side effects. Regular lab tests, like the urinary free cortisol test and ACTH stimulation test, can help assess your hormone levels and ensure your safety while using these products.

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, in rare cases, you could experience symptoms that are not just localized to the area where you applied the medication.

If you suspect an overdose, look out for unusual symptoms such as increased thirst, frequent urination, or changes in mood. It’s important to seek immediate medical help if you experience any severe reactions or if you are unsure about your symptoms. Always consult your healthcare provider if you have concerns about the use of topical corticosteroids or if you think you may have used too much.

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’s 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

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 they can be absorbed into the bloodstream in significant amounts that would show up in breast milk.

Because of this uncertainty, it's best to be cautious when using topical corticosteroids while nursing. Always consult with your healthcare provider to discuss any medications you are considering and to ensure the safety of 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 these treatments than adults. This increased sensitivity can lead to serious side effects, such as adrenal suppression (a condition where the body doesn't produce enough hormones) and Cushing’s syndrome (a hormonal disorder caused by high levels of cortisol). Signs of these issues in children can include slowed growth, delayed weight gain, and unusual symptoms like headaches or bulging fontanelles (the soft spots on a baby's head).

To minimize risks, you should use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition. Prolonged use of these medications can potentially affect your child's growth and development, so it's crucial to follow your healthcare provider's guidance closely. Always consult with a doctor if you have concerns about your child's treatment.

Geriatric Use

As you care for older adults, it's important to be aware that they may be more sensitive to the side effects of topical corticosteroids, which are medications often used to reduce inflammation and treat skin conditions. While there are no specific dosage changes recommended for older patients, caution is advised due to this increased sensitivity.

Additionally, using these medications for a long time or applying them over large areas of skin can lead to a condition called HPA axis suppression, where the body’s hormone production is affected. This is particularly concerning for older adults, so it's essential to monitor for any signs of this issue. Always consult with a healthcare provider to ensure safe and effective use of these treatments.

Renal Impairment

If you have kidney problems, 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 body's hormone regulation, specifically the hypothalamic-pituitary-adrenal (HPA) axis. If you experience signs of HPA axis suppression, which can be checked through specific tests, your healthcare provider may recommend reducing the use of the corticosteroid or stopping it altogether.

When you discontinue the medication, your HPA axis function usually returns to normal quickly. However, in rare cases, you might experience withdrawal symptoms, which could require additional corticosteroid treatment. Always consult your healthcare provider for personalized advice and monitoring if you have renal impairment while using corticosteroids.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed from your body through your kidneys. Some of these medications can also be found in your bile. If you use topical corticosteroids, there is a risk of affecting your body's hormone balance, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which can lead to suppression of hormone production.

If tests show that your HPA axis is suppressed, such as through urinary free cortisol and ACTH stimulation tests, your healthcare provider may recommend reducing the use of the corticosteroid or stopping it altogether. Fortunately, most people recover their hormone function quickly and completely after stopping the medication. However, in rare cases, you might experience withdrawal symptoms, which could require additional corticosteroid treatment. Always consult your healthcare provider for personalized advice and monitoring.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if they include topical corticosteroids. These medications can sometimes be absorbed into your body in a way that affects your hormone levels, potentially leading to conditions like Cushing’s syndrome, high blood sugar, or other health issues. Factors that can increase this absorption include using stronger steroids, applying them over large areas of skin, using them for a long time, or covering them with dressings.

Additionally, if you are undergoing tests like the urinary free cortisol test or the ACTH stimulation test, let your doctor know about your corticosteroid use. These tests can help assess how well your body’s hormone system is functioning. Always keep your healthcare provider informed to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature according to the United States Pharmacopeia (USP). It's important to keep the product protected from freezing, as exposure to low temperatures can damage it.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

If you're undergoing evaluation for conditions related to the hypothalamic-pituitary-adrenal (HPA) axis, two tests may be particularly useful: the urinary free cortisol test and the ACTH (adrenocorticotropic hormone) stimulation test. These tests help assess how well your body’s stress response system is functioning and can provide important information about your health. If your doctor recommends these tests, they will explain what to expect and how to prepare for them.

FAQ

What is Anusol-HC® 2.5%?

Anusol-HC® 2.5% is a topical corticosteroid cream containing hydrocortisone 2.5% as the active ingredient, used for anti-inflammatory and antipruritic (itch relief) purposes.

How should I use Anusol-HC® 2.5%?

You should apply Anusol-HC® 2.5% to the affected area two to four times daily, depending on the severity of your condition.

What are the possible side effects of Anusol-HC® 2.5%?

Possible local side effects include burning, itching, irritation, dryness, and skin atrophy, among others.

Are there any contraindications for using Anusol-HC® 2.5%?

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

Can I use Anusol-HC® 2.5% 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 Anusol-HC® 2.5% safe for pediatric patients?

Pediatric patients may be more susceptible to side effects, including HPA axis suppression and Cushing’s syndrome, so use should be limited to the least amount necessary.

What should I do if I experience irritation while using Anusol-HC® 2.5%?

If irritation develops, you should discontinue use and consult your healthcare provider for appropriate therapy.

How should Anusol-HC® 2.5% be stored?

Store Anusol-HC® 2.5% at 20° to 25°C (68° to 77°F) and protect it from freezing.

Packaging Info

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

Packaging configurations for Anusol.
Details

FDA Insert (PDF)

This is the full prescribing document for Anusol, 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

Anusol-HC® 2.5% is a topical corticosteroid formulation containing hydrocortisone 2.5% as the active ingredient. Hydrocortisone, with the chemical name Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-, is a synthetic steroid utilized for its anti-inflammatory and antipruritic properties. The cream is presented in a water-washable dosage form and includes the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer homopolymer, sodium lauryl sulfate, edetate disodium, sodium hydroxide for pH adjustment, 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 noted in the available data.

Dosage and Administration

Anusol-HC 2.5% (hydrocortisone cream, USP) is indicated for topical application to the affected area. The recommended frequency of application is two to four times daily, with the specific frequency determined by the severity of the condition being treated.

For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be employed to enhance the therapeutic effect. However, if signs of infection occur, the use of occlusive dressings should be immediately discontinued, and appropriate antimicrobial therapy should be initiated.

Contraindications

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

In cases of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If irritation develops, topical corticosteroids must be discontinued, and if a favorable response to the infection treatment does not occur promptly, the corticosteroid should be stopped 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, which may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent steroids, application over extensive body areas, prolonged treatment duration, and the use of occlusive dressings.

In cases where irritation occurs, it is imperative to discontinue the use of topical corticosteroids and initiate appropriate therapeutic measures. Should dermatological infections arise, the application of suitable antifungal or antibacterial agents is recommended. If there is no prompt favorable response, the corticosteroid should be halted until the infection is adequately managed.

Monitoring for HPA axis suppression is crucial. If suppression is detected, as indicated by urinary free cortisol and ACTH stimulation tests, efforts should be made to withdraw the corticosteroid or reduce the frequency of its application. Typically, recovery of HPA axis function is rapid and complete following discontinuation of the drug. However, in rare instances, signs and symptoms of steroid withdrawal may present, necessitating the use of supplemental systemic corticosteroids.

Pediatric patients are particularly vulnerable to systemic toxicity due to their potential for greater absorption of topical corticosteroids. Therefore, careful consideration and monitoring are essential when prescribing these medications to this population.

To evaluate HPA axis suppression, healthcare professionals may utilize the urinary free cortisol test and the ACTH stimulation test as part of their monitoring strategy.

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, acneiform eruptions, hypopigmentation, perioral dermatitis, striae, miliaria, skin atrophy, maceration of the skin, hypertrichosis, allergic contact dermatitis, and secondary infections.

In addition to local reactions, systemic absorption of topical corticosteroids has been associated with serious adverse effects, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Infrequently, patients may also experience signs and symptoms of steroid withdrawal, which may necessitate the use of supplemental systemic corticosteroids.

Pediatric patients are particularly vulnerable to the adverse effects of topical corticosteroids. They may exhibit a greater susceptibility to HPA axis suppression and Cushing’s syndrome compared to adults. Reports indicate that pediatric patients receiving topical corticosteroids have experienced HPA axis suppression, Cushing’s syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

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 corticosteroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.

In the context of monitoring for potential HPA axis suppression, the urinary free cortisol test and the ACTH stimulation test are recommended for evaluating the extent of suppression. Regular assessment may be necessary for patients at higher risk due to the aforementioned conditions that increase systemic absorption.

Packaging & NDC

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

Packaging configurations for Anusol.
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 higher skin surface area to body weight ratio. 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. 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. Prolonged use of corticosteroids may adversely affect the growth and development of pediatric patients.

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.

It is important to note that systemic absorption of topical corticosteroids can result in reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, a concern that may be particularly relevant for geriatric patients. Factors that can enhance systemic absorption include prolonged use and application over large surface areas, conditions that may be more prevalent in the elderly population.

Healthcare providers should monitor elderly patients for signs of HPA axis suppression, as they may be more susceptible to the systemic effects of these medications. Regular assessment and vigilance in this demographic are essential to ensure safe and effective treatment outcomes.

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 to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is advised that drugs of 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

Patients with renal impairment may experience altered pharmacokinetics of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. It is important to consider that some topical corticosteroids and their metabolites are also excreted into the bile.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, a condition that may be particularly relevant in patients with reduced kidney function. If HPA axis suppression is detected, as indicated by urinary free cortisol and ACTH stimulation tests, it is advisable to either withdraw the corticosteroid or reduce the frequency of its application.

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.

Hepatic Impairment

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

Topical corticosteroids, while generally used for localized treatment, can be systemically absorbed, leading to potential reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This risk is particularly pertinent in patients with compromised liver function. If HPA axis suppression is suspected, as indicated by urinary free cortisol and ACTH stimulation tests, it is recommended to either withdraw the corticosteroid or reduce the frequency of its application.

Upon discontinuation of the corticosteroid, recovery of HPA axis function is typically prompt and complete. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which may necessitate the administration of supplemental systemic corticosteroids. Therefore, close monitoring of patients with hepatic impairment is essential to ensure safe and effective use of corticosteroids.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in amounts sufficient to elicit systemic effects. Healthcare professionals should be vigilant in monitoring for signs of overdosage, particularly in patients who may have used these medications excessively or inappropriately.

Recommended Actions

In the event of suspected overdosage, it is crucial to assess the patient for any systemic effects that may arise from the corticosteroid absorption. Immediate evaluation and monitoring of the patient’s clinical status are recommended.

Potential Symptoms

Symptoms of corticosteroid overdosage may include, but are not limited to, signs of adrenal suppression, such as fatigue, weakness, and hypotension. Other systemic effects may manifest as Cushing's syndrome, characterized by weight gain, hypertension, and glucose intolerance.

Management Procedures

Management of corticosteroid overdosage should focus on supportive care and symptomatic treatment. If systemic effects are observed, it may be necessary to taper the corticosteroid dosage gradually to mitigate withdrawal symptoms and restore normal adrenal function. Consultation with a specialist in endocrinology may be warranted for severe cases or for further management strategies.

Healthcare professionals are advised to refer to the PRECAUTIONS section for additional information regarding the risks associated with the use of topical corticosteroids and to ensure appropriate patient education on the correct application and dosage of these medications.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility associated with topical corticosteroids. Additionally, investigations aimed at determining the mutagenicity of hydrocortisone have yielded negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, 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 use, and the addition of occlusive dressings.

In cases where HPA axis suppression is identified through urinary free cortisol and ACTH stimulation tests, it is recommended to withdraw the drug or reduce the frequency of application. Recovery of HPA axis function is typically prompt and complete following discontinuation of the drug; however, infrequent occurrences of steroid withdrawal symptoms may necessitate supplemental systemic corticosteroids.

Pediatric patients may experience proportionally greater absorption of topical corticosteroids, rendering them more susceptible to systemic toxicity. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in this population. Manifestations of adrenal suppression in pediatric patients may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as 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, acneiform eruptions, hypopigmentation, striae, perioral dermatitis, miliaria, folliculitis, maceration of the skin, hypertrichosis, secondary infection, and allergic contact dermatitis.

To report suspected adverse reactions, individuals are encouraged to contact Salix Pharmaceuticals at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Patient Counseling

Patients should be instructed to use this medication strictly as directed by their physician. It is intended for external use only, and they must avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should emphasize that patients must not use this medication for any condition other than the one for which it has been prescribed. This ensures the safety and efficacy of the treatment.

Patients should 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 important to prevent potential adverse reactions.

It is crucial for patients to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing. Prompt reporting can help manage any complications that may arise.

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

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. It is imperative to protect the product from freezing to maintain its integrity and efficacy.

Additional Clinical Information

The urinary free cortisol test and the ACTH stimulation test are valuable tools for clinicians in assessing hypothalamic-pituitary-adrenal (HPA) axis suppression in patients. These tests can provide critical insights into the functioning of the HPA axis, aiding in the diagnosis and management of related conditions.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Anusol as submitted by Salix Pharmaceuticals, 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 Anusol, 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 (ANDA088250) 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.