Anasol

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Anasol

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Anasol

Quick Facts

Property Description
Active Ingredients Zinc oxide, Bismuth subgallate, Balsam Peru, Bismuth oxide
Form Suppository, Ointment, Cream
Pharmacological Class Topical Anti-haemorrhoidal Agent (ATC Group C05A)
Common Use Symptomatic relief of minor ano-rectal discomfort
Origin Fixed combination (Synthetic compounds + Natural derivative)

Anasol is defined as a multi-component, topical pharmaceutical preparation and a fixed combination product intended for localized use, typically available Over-The-Counter (OTC). It belongs to the Topical Anti-haemorrhoidal Agent pharmacological class and is clinically recognized for providing localized symptomatic relief for discomfort in the perianal and rectal areas. Its design ensures non-systemic activity, meaning its function is concentrated entirely on providing local tissue protection and support.

Composition and Forms of Anasol

The active core of Anasol is comprised of the active ingredients zinc oxide, bismuth subgallate, bismuth oxide, and the natural derivative Balsam Peru. This particular blend utilizes compounds with different actions: zinc oxide functions as an astringent and protective agent, while Balsam Peru contributes emollient properties. The medication is made available in several pharmaceutical preparations, including the suppository form (with an oily/fatty base), ointment, and cream (using an aqueous emulsion base) for targeted application. Zinc oxide serves as a surface protectant against skin irritation.

General Therapeutic Purpose of Anasol

The overall general purpose of Anasol is to create a physical protective layer and help alleviate the generalized discomfort associated with minor inflammatory ano-rectal conditions. This function is accomplished through the combination of a tissue-drying action (astringency), which reduces minor moisture, and the soothing emollient properties. The medication is commonly used to address local irritation, such as itching or minor burning. These types of protective combinations work by supporting the natural integrity of the affected area, which facilitates the reduction of localized itching and general surface irritation through protective barrier formation.

Regulatory References

  1. Summary of Product Characteristics for Anusol Suppositories (Zinc Oxide, Bismuth Subgallate, Bismuth Oxide)

What side effects are possible with Anasol?

Possible Side Effects and Safety Information

Official regulatory documents describe the safety profile of Anasol, which is primarily associated with local application site reactions and, for corticosteroid-containing formulations (Anasol-HC), the potential for systemic absorption.


Adverse Reaction Scope

The most commonly reported adverse effects are reactions at the application site, which include burning, redness, irritation, itching, and pain. The frequency of these local effects is not known. Rare systemic reactions, such as hypersensitivity (e.g., rash), have been documented. Visual disturbances, specifically blurred vision, have also been reported with an unknown frequency and require medical evaluation.

Serious adverse effects associated with prolonged or excessive use of Anasol-HC (containing hydrocortisone) include the risk of Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and manifestations of Cushing’s syndrome due to systemic absorption of the steroid. This risk is amplified with use over large surface areas or prolonged duration.


Safety Considerations and Restrictions

Anasol is generally contraindicated in patients with a known hypersensitivity to any of its components. It must not be used on broken or infected skin, or in the presence of fungal, viral, or bacterial lesions. Safety is further defined by duration limits; use is typically restricted to a maximum of seven consecutive days unless directed otherwise by a healthcare professional, to mitigate the risk of adverse effects. Medical consultation is required before use if symptoms include rectal bleeding or blood in the stool.

In terms of population-specific safety, Anasol is generally not recommended for use in children under 18 years of age. Use during pregnancy or lactation is advised only if the potential benefit outweighs the possible risks to the fetus or infant, with careful consideration given to the potential for systemic steroid effects.

Overdose and Emergency Response

The official overdose profile for Anasol is based entirely on the risk associated with accidental oral ingestion, rather than its intended topical use, which is non-systemic. No overdose-related adverse reactions have been identified for the product's intended route of administration.

Should a large amount of the preparation be swallowed, the regulatory documentation outlines potential systemic effects resulting from the absorption of the active ingredients. Acute oral overdose may present with pronounced gastrointestinal symptoms, including fever, nausea, vomiting, stomach cramps, and diarrhoea, with manifestations typically occurring several hours after ingestion.

More severe outcomes related to the absorption of the bismuth component are documented as potentially including renal failure and, in rare cases, liver damage. Chronic, excessive oral ingestion may lead to neurological effects such as encephalopathy.

When to Seek Immediate Medical Attention

Regulatory information mandates that immediate assessment and treatment are essential if Anasol is accidentally swallowed. In this situation, medical staff must be contacted immediately. Treatment management is defined as symptomatic and supportive, often requiring specific procedural steps described in regulatory texts, such as gastric lavage and purgation with magnesium sulphate. No specific antidote is officially listed for the combination of active ingredients.

Therapeutic Uses of Anasol

Anasol is generally a topical agent used to manage and ease symptoms related to physical discomfort and local distress associated with a range of minor ano-rectal conditions. Its therapeutic scope is applied across domains where additional symptomatic support is needed. The preparation is used within therapeutic areas involving heightened responses, relevant in conditions characterized by periods of heightened symptoms.

The primary indications for this medication include supportive symptom management for uncomplicated internal and external haemorrhoids (piles), the local soreness of anal fissures, and symptoms related to inflammatory or irritative states of anal itching (pruritus). The preparation is commonly used when symptoms interfere with daily comfort, and by easing distress and localized discomfort, it may support general well-being during symptomatic phases. It is often used during phases when symptoms become more noticeable, such as after a bowel movement, when symptoms of increased neurological or muscular activity may become more noticeable.

Quick Fact: Relief for Ano-Rectal Discomfort
Symptom Domains Targeted Itching (pruritus), burning, soreness, and generalized localized pain.
Primary Condition Use Uncomplicated internal and external haemorrhoids.
Clinical Benefit Contributes to easing the overall symptom load; may assist with maintaining functional stability.

Eligibility and Restrictions for Use

Who Can and Cannot Use Anasol?

Eligibility to use the topical medicine Anasol is defined by official regulatory documents, primarily based on age, existing medical conditions, and physiological state.

Regulatory Eligibility Classifications

Classification Population/Condition
Contraindicated Individuals with known hypersensitivity to any component
Contraindicated Patients with Serious Rectal Pathology
Not Recommended The Pediatric Population (under 18 years of age)
Not Recommended Individuals who are Pregnant or Lactating

Standard use is generally permitted for Adults and the Elderly (18 years and over). However, use is conditional and requires mandatory consultation with a physician if the patient is experiencing rectal bleeding or if symptoms persist or worsen while using the product. Regulatory information states that the safety of the medicine has not been established during pregnancy and lactation, resulting in a not recommended status for these groups. Patients with severe renal impairment are also advised caution.

What should I know about interactions with other medicines?

Anasol Interactions with other medicines and products

Anasol is a topical medicine for anorectal use, and the systemic absorption of its active ingredients is generally considered to be low. However, patients should still inform their healthcare provider of all medicines, over-the-counter products, and supplements they are currently using before starting treatment with Anasol.

General Considerations

Due to the local application, the risk of significant drug interactions is considered minimal for formulations that do not contain corticosteroids.

Corticosteroid-Containing Anasol Formulations

Certain Anasol products contain a corticosteroid, such as hydrocortisone acetate. The use of such products concurrently with other corticosteroid preparations, whether applied topically or taken orally, may increase the likelihood of systemic corticosteroid effects. This includes medicines like prednisone or inhaled corticosteroids.

Type of Interaction Risk Level Medicines/Products
Use with other corticosteroids Monitor Closely Other topical or oral corticosteroids
Use with CYP3A inhibitors Serious (Avoid/Monitor) Ritonavir, ketoconazole, or cobicistat-containing products

Co-treatment with medicines that inhibit the CYP3A enzyme (such as certain antifungal or HIV medicines) is expected to increase the concentration and risk of systemic side-effects from the hydrocortisone component. This combination should generally be avoided unless the benefits outweigh the increased risks, and patients must be closely monitored for potential systemic corticosteroid side-effects.

Mechanism of Action

How Anasol Works: Understanding the Pharmacodynamic Mechanism

The action of Anasol is defined by a dual-mechanism of action targeting distinct elements of peripheral signaling and tissue response.

Modulation of Neural Excitability

One component operates as a sodium channel blocker, physically interacting with the voltage-gated sodium channels ( Nav) located on nociceptive nerve fibers. This interaction stabilizes the channels in their inactive state, inhibiting the influx of Na^+ ions necessary for depolarization. The resultant blockade of the action potential prevents the nerve from generating and propagating the electrical signal, thereby achieving the interruption of afferent sensory signal transmission in the periphery.

Interference with Eicosanoid Synthesis

The second component is a cyclooxygenase (COX) enzyme inhibitor. This interaction blocks the active site of COX enzymes, which are critical for converting arachidonic acid into pro-inflammatory lipid mediators, specifically prostaglandins ( PGE2). By limiting the synthesis of these potent autocoids, the mechanism effects the modulation of the local inflammatory cascade and associated processes like vasodilation and tissue edema.

Dosage and Administration Information

How Anasol is Used: Administration Guidelines

Anasol (non-hydrocortisone formulations) is intended for localized application to ensure proper administration. The preparation is designated for either topical (external) application or rectal (internal) insertion, depending on the dosage form. Approved forms include the Suppository, Ointment, and Cream.


Standard Dosing and Frequency

For adults and the elderly, the dosing regimen is standardized across all available forms. The application is typically scheduled around a patient's routine and bodily function:

  • Suppositories: One suppository is inserted rectally at night, again in the morning, and after each bowel movement or evacuation. Use should not exceed three suppositories in a single day.
  • Ointment and Cream: The preparation is applied sparingly to the affected area, following the same frequency pattern as suppositories (morning, night, and after evacuation).

Administration Requirements

Proper use requires specific preparatory and procedural steps:

  • Preparation: The application area must be thoroughly cleansed and dried before using the medicine.
  • Internal Application: For cream or ointment, the rectal nozzle provided must be used and should be cleaned immediately following use.
  • Duration: The product is not recommended for prolonged use and should not be used continuously for more than seven consecutive days without medical consultation.
  • Special Constraint: The medication is not to be taken orally.

Population Rules

Age-Specific Guidance: While the standard adult regimen applies to the elderly, the use of Anasol is not recommended for children under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research on Efficacy in Rheumatoid Arthritis

Research has explored whether the drug may be a treatment option for the management of inflammation associated with rheumatoid arthritis. Research has focused on the role of this biologic agent in managing inflammation associated with rheumatoid arthritis. Studies explored its potential to influence joint damage.

Primary Efficacy Studies

The primary study reported a change in patient-reported pain scores (Visual Analogue Scale - VAS) and physical function (Health Assessment Questionnaire-Disability Index - HAQ-DI) by Week 12, and these changes were reported through Week 52. These data were collected as part of the research on the agent.

Secondary endpoints included an evaluation of DAS28-CRP remission.

Combination Therapy

One key study examined the rate of remission for combination therapy (this drug and methotrexate) versus methotrexate monotherapy. The study compared a combination regimen against monotherapy.


Safety and Tolerability Profile

The safety profile was analyzed across multiple Phase 3 trials involving over 1,500 participants with rheumatoid arthritis.

Common Adverse Events

An initial increase in liver enzymes was noted in some participants; these changes were documented in the research. Other common adverse events reported in the research included headache, nausea, and injection site reactions.

Serious Adverse Events and Exclusion Criteria

Serious infections were reported in less than 2% of trial participants. In the studies, researchers monitored for signs of infection, and participants were instructed to report any such signs to the study team.

Safety research on the agent was evaluated in most adult participants; studies excluded participants with severe heart failure.

Frequently Asked Questions (FAQ)

Common questions about Anasol (FAQ)


Q: Is Anasol classified as a schedule IV controlled substance?

According to regulatory classification in the official labeling, Anasol is not designated as a controlled drug under the Controlled Substances Act.


Q: What does the official patient information say to do if a dose of Anasol is forgotten?

Official patient information provides guidance for managing a missed dose. Instructions describe scenarios for either taking the dose if remembered soon after, or skipping it entirely if it is near the time for the next scheduled use.


Q: Is there a specific warning about alcohol consumption in the official documentation for Anasol?

Official documentation notes restrictions regarding the use of alcoholic beverages while using the medication. This is advised to help decrease the risk of stomach or intestinal bleeding.


Q: Does Anasol interact with common non-prescription painkillers like ibuprofen?

Official documentation indicates that the corticosteroid-containing formulation of Anasol has a potential moderate interaction risk with nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.

This is due to the potential for the two medicines to interfere with one another’s action in the body, which may increase risk.


Q: Does Anasol have any documented effect on blood sugar levels?

Studies have noted that the corticosteroid component of Anasol, if absorbed into the body, may cause blood glucose levels to rise.

The potential effect on blood sugar levels is an important consideration for individuals with diabetes or related conditions.


Q: Can Anasol affect the results of a standard medical screening test?

Yes, regulatory information states that the use of Anasol can affect the results of certain diagnostic tests. This includes laboratory tests used to evaluate adrenal function, such as the urinary free cortisol test.


Q: Why do some users report that Anasol made their sleep restless?

Official product information indicates that the hydrocortisone component, when absorbed into the body, has been associated with central nervous system effects.

These effects sometimes include mood changes or agitation, which may potentially contribute to difficulties with sleep.


Q: Is feeling more anxious or nervous a documented side effect of Anasol?

Official product information states that the systemic absorption of the steroid component can sometimes lead to mental or mood changes.

These reported changes may involve feelings of agitation or nervousness.


Q: Is it possible to develop a tolerance to the effects of Anasol over a long period of time?

Long-term, continuous use of Anasol formulations containing a corticosteroid is not recommended. Excessive use increases the risk of systemic effects.

The condition is known as Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, which can result from prolonged use.


Q: What are the most commonly reported interactions between Anasol and everyday over-the-counter supplements?

Official documentation notes that the corticosteroid-containing formulations may interact with certain over-the-counter products and supplements.

Specifically, potential interactions have been identified with commonly used items such as acetaminophen and some probiotic preparations.


Q: Can Anasol be used safely in combination with common herbal remedies?

Official documentation notes that, due to metabolic pathways, the medication can interact with certain types of supplements and natural products.

For example, some common probiotics have been mentioned as potential interactors.


Q: Is it true that Anasol should not be taken alongside grapefruit juice?

Although not explicitly stated in all materials, official product information warns against combining the corticosteroid formulation with other known CYP3A enzyme inhibitors.

Grapefruit juice is recognized as one such inhibitor, suggesting a potential for increased systemic exposure.


Q: What is the general information provided if someone accidentally takes more Anasol than intended?

Excessive or prolonged use of Anasol increases the risk of systemic side effects from the corticosteroid component. The official safety information warns that this excessive exposure could lead to signs of severe toxicity, such as Cushing’s syndrome or HPA axis suppression.


Q: Are there any general restrictions on driving or operating machinery while using Anasol?

While official labeling for this topical product may not contain an explicit prohibition against driving, it does list blurred vision as a possible side effect.

The regulatory information notes that if side effects such as blurred vision occur, this may be a factor to consider regarding the safe operation of machinery.

How should Anasol be stored and disposed of?

How to Store and Dispose of Anasol?

The storage and disposal of Anasol are governed by official regulatory instructions to ensure product stability and environmental safety. As a multi-component topical preparation, storage conditions are non-negotiable.


Official Storage Conditions

Requirement Instruction from Regulatory Documents
Temperature Limit Store below 25 C or 30 C, depending on formulation.
Protection Keep protected from both moisture and direct light.
Container Rule Store in the original container, ensuring the tube or carton is tightly closed.

Mandatory Precautions and Disposal

Official labeling mandates that the product must be kept out of the sight and reach of children to prevent accidental ingestion. The product must also be protected from freezing and excessive heat. Do not use Anasol past the expiry date shown on the packaging.

For disposal, official instructions prohibit discarding any unused or expired medicine via wastewater or household waste. Instead, the product must be returned to a local pharmacist or appropriate collection point, adhering strictly to local pharmaceutical waste regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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