Lotagen

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Lotagen

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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 Lotagen

Property Description
Active ingredient Policresulen (INN)
Form Aqueous Solution, Suppositories, Ointment
Pharmacological class Antiseptic, Hemostatic, Astringent
Common route Topical Application (cutaneous, mucosal)
Origin Synthetic, Polymeric Organic Acid

What Type of Medicine is Policresulen?

Policresulen (INN), often recognized under the trade name Lotagen, is a chemically synthetic drug entity, derived as a polycondensation product of formaldehyde and meta-cresolsulfonic acid. It is classified as an antiseptic, a hemostatic, and a strong astringent agent. The unique chemical process that creates this polymeric organic acid is the foundational aspect that defines its highly acidic and locally confined function.

The general therapeutic purpose of this class of medicine is clinically recognized for promoting the management of local tissue damage. For instance, it is commonly used in contexts where tissue cleansing and minor localized bleeding control are required.


Policresulen's Available Forms and General Therapeutic Role

Policresulen is formulated exclusively for topical application onto affected skin or mucous membranes. Its core dosage forms include the common aqueous solution (often a concentrate), as well as vaginal suppositories and specialized cutaneous ointment bases, allowing for versatile site-specific delivery. The drug’s general therapeutic function is rooted in its ability to achieve selective coagulation and antimicrobial action. This mechanism involves the targeted denaturation of proteins found specifically in damaged or diseased cells, which facilitates tissue regeneration.


Defining the Composition and Chemical Differentiation

The core active ingredient is Policresulen. The molecule's high polymeric structure is a crucial differentiating factor because it prevents significant absorption into the bloodstream when applied topically. This property ensures that the drug's powerful astringent and antiseptic effects are maximally concentrated at the immediate area of application, minimizing the risk of systemic exposure and reinforcing its specialized local tissue management function.

What side effects are possible with Lotagen?

Possible Side Effects and Safety Information

The safety profile for Policresulen, as documented in official prescribing information, is predominantly characterized by localized effects at the site of topical application. The high molecular weight of the drug limits systemic absorption, which aligns with the local nature of most reported adverse reactions.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to standard regulatory frequency standards:

  • Very Common: Vaginal dryness.
  • Common: Burning sensation in the vagina; Discharge of shreds of mucous membrane.
  • Not Known: Systemic allergic reactions up to anaphylaxis (the most serious documented event); Vaginal candidiasis; Pruritus vulvae; Urticaria; Discomfort in the vagina; Foreign body sensation in the vagina.

These effects primarily fall under the Reproductive System and Breast Disorders class, with severe systemic allergic potential documented under Immune System Disorders.

General Safety and Constraints

Certain local effects are noted in regulatory documents. Local irritation, such as burning or pain, is described as occasional and typically transient. The label specifies that the discharge of necrotic tissue is considered an expected sign of the local therapeutic effect.

Safety notes include a requirement to avoid washing with soaps that trigger irritation during the treatment period. Furthermore, the product must be discontinued if severe local irritation occurs.

Population-Specific Safety Considerations

Official labeling requires specific caution for certain populations:

  • Pregnancy and Breastfeeding: Use is restricted to cases that are strictly indicated and must follow a specific risk-benefit assessment. Application to the cervix should be avoided in pregnant women, especially during advanced stages.

Overdose and Emergency Response

Lotagen Overdose and When to Seek Help

Note on Product Identity: The trade name Lotagen is associated with different products in human and veterinary medicine, complicating a single, unified overdose profile. In some pharmaceutical contexts, Lotagen refers to a combination product containing Losartan and Hydrochlorothiazide, used to manage high blood pressure. Separately, the name has been historically applied to a topical agent containing policresulen (metacresolsulphonic acid and formaldehyde), used as an antiseptic and astringent for local treatment or in veterinary practice.


Potential Overdose Manifestations (Lotagen - Losartan/Hydrochlorothiazide)

An overdose of a combination product containing losartan and hydrochlorothiazide is primarily associated with symptoms relating to their mechanism of action. Excessive intake may lead to profound hypotension (severely low blood pressure), which can manifest as dizziness, lightheadedness, and fainting. Hydrochlorothiazide, a diuretic, may also cause excessive fluid and electrolyte loss, resulting in dehydration and electrolyte imbalance, such as low potassium levels (hypokalemia).

When Immediate Medical Help is Required:

  • Contact emergency medical services immediately if a suspected overdose is accompanied by symptoms of severe hypotension (e.g., profound dizziness, fainting, or inability to be aroused) or signs of severe dehydration or electrolyte disturbance.

Topical Agent Overdose (Policresulen/Lotagen)

Information regarding systemic overdose from the topical use of policresulen (metacresolsulphonic acid), which is also marketed under the name Lotagen, is limited, as the product is intended for external or local application. In the event of accidental massive oral ingestion of the topical solution, professional medical advice should be sought without delay to manage potential chemical irritation and any systemic effects.

Therapeutic Uses of Lotagen

What Lotagen Treats: Main Uses and Benefits


The therapeutic function of Policresulen (Lotagen) is generally applied for localized, symptomatic support across key tissue domains relevant to conditions involving inflammatory or irritative states and minor surface bleeding. It is commonly used when symptoms create noticeable interference with daily comfort and require supportive management. Its primary relevance lies in topical application to damaged or inflamed tissues.

Symptom-Focused Therapeutic Areas

The medication is relevant in situations where symptoms cluster into patterns requiring support for local tissue repair. It is applied when appropriate to ease challenging symptoms across several areas, including managing gynecological lesions and inflammation, providing support for anorectal symptoms and hemostasis, and assisting healing for skin and oral ulcers. In clinical settings, it is used for conditions such as cervical erosions, vaginitis, hemorrhoids, anal fissures, slow-healing wounds, and oral ulcers.

Quick Fact: Supports Management of Localized Inflammation and Minor Bleeding


Patient Benefit and Symptom Management

Policresulen helps address symptoms including localized pain, itching (pruritus), and small-scale surface hemorrhage. It is applied to ease challenging symptoms by assisting with the local cleansing and removal of abnormal tissue and providing antiseptic support, which contributes to the natural process of tissue repair and may assist with maintaining functional stability when local lesions become noticeable. The use of this medication contributes to providing supportive relief that helps ease the overall symptom burden during difficult episodes.

Regulatory References

  1. DailyMed drug information on Policresulen

Eligibility and Restrictions for Use

Who Can and Cannot Use Lotagen?

The eligibility for using Lotagen (Policresulen) is strictly defined by official regulatory labeling, ensuring appropriate use of this topical astringent and antiseptic agent. Eligibility information is based on government-approved prescribing summaries.


Populations with Restrictions or Prohibitions

Eligibility Category Population / Condition Official Regulatory Status / Rule
Allowed Adults (18+ years) Standard approved population for labeled topical indications.
Contraindicated Known Hypersensitivity Absolute prohibition for patients allergic to Policresulen or excipients.
Contraindicated During Menstruation Prohibited for vaginal/cervical dosage forms.
Restricted Children and Adolescents (under 18) Not recommended; safety and efficacy are not established in these age groups.
Restricted Pregnancy (First Trimester) Contraindicated or highly restricted; use only when deemed absolutely necessary.
Restricted Lactation (Breastfeeding) Not recommended due to insufficient data on excretion into breast milk.
Conditional Patients using Latex Contraceptives Product acidity may compromise the integrity of latex condoms or diaphragms.

Official prescribing information confirms that use is limited to adults and is contraindicated if a patient has a known allergy. Use in children, adolescents, and during the first trimester of pregnancy is generally not recommended.

What should I know about interactions with other medicines?

Lotagen is a medicinal product whose active substance is Policresulen, a polycondensation product of metacresolsulfonic acid and formaldehyde, which acts as a topical antiseptic and hemostatic. In some countries, Lotagen is approved for veterinary use (cattle, horses, pigs, dogs, and cats), while the active ingredient Policresulen is also available in human formulations under other brand names (e.g., Albothyl, Faktu combination product).

Since Policresulen is primarily intended for local application to the skin or mucous membranes, its systemic absorption into the bloodstream is considered minimal. Consequently, the potential for typical systemic drug-drug interactions (e.g., those involving liver enzymes like cytochrome P450) is low.

However, local interactions remain a concern for topical treatments. Due to the high acidity of Policresulen solutions, patients are generally advised to avoid the concurrent local use of other drugs or products in the same area. Specifically, combining Policresulen with other topical antiseptic or disinfectant agents should be avoided, as this may lead to chemical reactions that diminish the efficacy of both treatments or increase local irritation. To ensure safety and efficacy, it is recommended to discuss all concurrent medications and topical treatments with a healthcare professional.

Mechanism of Action

Lotagen, which is policresulen, operates through a localized, physicochemical mechanism of action, primarily targeting pathologically altered or necrotic tissue at the site of application. The compound is highly acidic, and this property is the core biological target modifier. The hydrogen ion concentration induces the denaturation and subsequent coagulation of cellular and tissue proteins. This interaction causes an immediate, selective necrosis and sloughing of the targeted tissue layers due to the physical precipitation of cellular macromolecules. Downstream physiological consequences include localized vasoconstriction and the coagulation of blood proteins, leading to a modulation of local blood flow and promotion of hemostasis. This dual action modifies the tissue environment via macromolecular precipitation and local circulatory restriction.

Dosage and Administration Information

Administration Scope and Route

Policresulen (Lotagen) is for topical/mucosal application and is not for oral ingestion. Administration utilizes specific dosage forms: the vaginal suppository or concentrate solution for gynecological use, and the aqueous solution for use as a buccal rinse. Standard regimens specify one suppository per application or approximately half a capful for the rinse.

Dosing Schedule and Frequency

Dosing is characterized by localized, specific protocols. The vaginal suppository is typically administered as a single unit dose once every two days. For the buccal solution, use is generally limited to up to four times daily and is specifically scheduled after meals and at bedtime to ensure appropriate contact time with the mucosa. Children aged 2 years and older may use the buccal solution, though those under 12 require supervision.

Procedural Conditions and Duration

Treatment courses are short-term and limited. Vaginal use is not to exceed 9 days, and the buccal rinse is limited to 7 days unless otherwise directed. Standard instructions detail specific procedural requirements: the vaginal suppository may be briefly immersed in water for easier insertion, and administration is advised to occur at night before going to bed. Furthermore, vaginal treatment is discontinued during menstruation, and sexual intercourse is avoided during the course of vaginal treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lotagen

The research primarily explores Policresulen as a substance studied for its local application in specific gynecological and anorectal conditions involving localized lesions or inflammation. The evidence base includes controlled clinical trials, non-comparative multicenter studies, and retrospective analyses, where researchers primarily investigated short-term outcomes related to localized symptoms and tissue changes.


Evidence for Use in Gynecological Lesions and Inflammation

Policresulen was studied for conditions characterized by inflammatory or irritative states of the vaginal and cervical tissue. Researchers explored the application of Policresulen in its solution or suppository forms, often comparing the substance to a placebo or other locally applied treatments. Studies focused on adult women, including those experiencing certain symptoms associated with postmenopausal status. The findings describe patterns observed in the studies related to physical discomfort and local tissue status, including the rate of re-epithelialization (tissue regeneration) and the frequency of local hemostasis (cessation of minor bleeding) observed over short- to intermediate-term periods. What remains uncertain is the long-term outcome data following treatment.


Evidence for Use in Anorectal Symptoms and Hemostasis

The research for anorectal symptoms, including hemorrhoids and anal fissures, involves controlled clinical studies and multicenter reports. The research examined outcomes related to physical discomfort and localized bleeding in adult patients. Studies reported measurements related to the change in patient-reported outcomes describing perceived discomfort, such as pain and itching, over short time intervals. However, the isolated contribution of Policresulen remains unclear in much of the data, as many studies examined fixed-combination products with other active ingredients.


Key Evidence Gaps and Areas of Uncertainty

While evidence exists for short-term effects, the data quality varies across studies, with a prevalence of older trials and a reliance on non-comparative designs for some indications. The final contribution of Policresulen as a single agent is often complicated by studies involving combination products. Follow-up durations were limited across the majority of the published evidence, contributing to a lack of comprehensive data on long-term effects. Clinical studies primarily focused on adult populations, meaning data for certain groups, such as children or pregnant women, remain insufficient.

Key Studies & References

  1. DailyMed: POLICRESULEN solution

Frequently Asked Questions (FAQ)

Common questions about Lotagen (FAQ)


Q: Does Lotagen have the same purpose as other skin treatments I see advertised?

A: Official information indicates that Policresulen (the active substance in Lotagen) is classified as an antiseptic, hemostatic (stops minor bleeding), and astringent agent. Its function is rooted in achieving the selective coagulation of altered tissue and promoting an antimicrobial action. This localized function helps define its role relative to other topical agents.

Q: Does Lotagen interact with common pain relievers like ibuprofen?

A: Because Policresulen is approved solely for local topical application, its absorption into the general bloodstream is considered minimal. Official documents therefore state that the potential for systemic drug-drug interactions with oral medications, such as common pain relievers, is considered low.

Q: Can Lotagen be used alongside herbal supplements?

A: Regulatory guidance suggests avoiding the concurrent local use of other topical treatments or products in the same area due to the potential for local chemical interactions. Concurrent use of herbal supplements or other topical agents is generally advised to be discussed with a healthcare professional.

Q: Does Lotagen interfere with contraceptive pills?

A: Official product information notes that the acidity of Lotagen may compromise the physical integrity of certain localized barrier contraceptives, such as latex condoms or diaphragms, when applied vaginally. Systemic interference with oral contraceptive pills is generally not addressed in regulatory documents.

Q: Why does Lotagen foam or bubble up when applied to some wounds?

A: The mechanism of action for Lotagen involves the highly acidic Policresulen causing the denaturation and coagulation of cellular proteins in pathologically altered tissue. This physicochemical reaction at the application site may be associated with the visible local effects, such as foaming or bubbling, that some users observe.

Q: Does Lotagen have anti-inflammatory properties?

A: Official overviews primarily classify the drug as an antiseptic and hemostatic agent. However, some scientific literature suggests the substance is associated with properties that modulate localized inflammation and swelling in the treated area.

Q: Are there any known long-term side effects of Lotagen?

A: Most documented adverse effects are local (at the site of application) and generally transient due to the drug's minimal systemic absorption. Regulatory research summaries indicate that while evidence exists for short-term outcomes, the available data on long-term effects following treatment remain insufficient.

Q: Is Lotagen sold over the counter, or do I need a prescription?

A: The dispensing status of medicines containing Policresulen can vary significantly depending on the specific country and formulation. Some formulations are regulated as Human Over-the-Counter (OTC) drugs, while others require a prescription.

Q: Can Lotagen be used on broken skin or open wounds?

A: Official labeling indicates that Lotagen is intended for use in local tissue damage and lesions. Its mechanism involves selective coagulation and the elimination of damaged tissue, which is associated with promoting the natural process of re-epithelialisation (tissue regeneration).

Q: Is it normal to feel a slight burning or stinging sensation when applying Lotagen?

A: Official product documentation notes that local irritation, such as a burning or stinging sensation, can occasionally occur after application. This effect is described as generally transient, meaning it typically disappears soon after use.

Q: What should I do if I accidentally get Lotagen in my eyes?

A: The product is corrosive and should not come into contact with the eyes. Safety instructions advise that if accidental contact occurs, the eyes should be immediately rinsed with water for several minutes, and regulatory safety information advises seeking medical attention.

Q: What is the typical duration of treatment with Lotagen?

A: Official regulatory guidance defines the maximum duration of treatment courses for specific applications. For example, vaginal use should typically not exceed 9 days, and the buccal rinse is limited to 7 days, unless otherwise directed by a healthcare provider.

Q: Can Lotagen be used to treat bacterial infections?

A: Policresulen is classified as an antiseptic agent in official documents. This means it is characterized by a broad range of antimicrobial activity, including activity against common bacteria, fungi, and certain viruses.

Q: Is the use of Lotagen supported by long-term clinical trials?

A: Official research summaries confirm that while evidence exists for the medicine's short-term effects, the follow-up duration was limited across the majority of published studies. This means there is a current lack of comprehensive data from long-term clinical trials.

Q: Can I apply other topical creams while using Lotagen?

A: Regulatory guidance suggests avoiding the concurrent local use of other antiseptic or disinfectant agents in the same area to ensure the efficacy of the treatment. The use of other topical creams is generally advised to be discussed with a healthcare professional.

Q: What is the difference between the gel form and the solution form of Lotagen?

A: Policresulen is manufactured in different dosage forms, including the aqueous solution, vaginal suppositories, and specialized ointments. These forms are designed to allow for site-specific delivery and appropriate application depending on the condition being addressed.

Q: What are the typical ingredients besides the active substance in Lotagen?

A: Official product documentation lists the excipients (or inactive ingredients) that are specific to each formulation, such as the solution or suppository. These ingredients complement the active substance, Policresulen, in the final product.

Q: What happens if Lotagen is swallowed?

A: Lotagen is intended exclusively for external use. In the event of accidental ingestion, safety instructions advise against inducing vomiting and recommend immediately contacting a physician or poison control center.

Q: Is Lotagen considered a regenerative medicine?

A: While it is not formally classified as a regenerative medicine, the drug's mechanism of action is described as facilitating tissue regeneration (re-epithelialization) by selectively targeting and removing damaged or necrotic tissue.

Q: What is the shelf life of Lotagen affected once the bottle is opened?

A: Official storage documentation specifies that for the concentrate solution, there is an in-use shelf life of 3 months after the bottle has been opened. Adherence to proper storage temperature and security requirements is important for maintaining stability.

Q: Is the mechanism of action of Lotagen fully understood by scientists?

A: The primary mechanism of action involving selective coagulation and hemostasis is well-defined in official documents. However, some scientific literature suggests that the mechanisms underlying all of its observed effects, such as its anti-inflammatory action, are not yet fully elucidated.

How should Lotagen be stored and disposed of?

How to Store and Dispose of Lotagen (Policresulen)

Official regulatory documents define specific requirements for the storage and disposal of this medicine to ensure stability and safety.


Storage and Handling Requirements

  • Temperature: The suppository formulation must be stored below 25 C.
  • Child Safety: The product must be kept out of reach of children (and out of their sight).
  • Container Security: The container, particularly the aqueous solution, must be kept tightly closed after each use.
  • Stability: The concentrate solution has an in-use shelf life of 3 months after the bottle is opened.

Disposal Instructions

Disposal of any unused or expired Lotagen must be carried out in accordance with local or national regulations. The substance must not be discharged into household sewer systems or allowed to enter drains, which protects the environment from potential contamination. Patients are advised to consult local pharmaceutical waste protocols for proper disposal.

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

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