Ichthraletten

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Ichthraletten

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Medically reviewed

Laura Arias

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 Ichthraletten

Quick Facts

Property Description
Active Ingredient Ichthammol (Ammonium bituminosulfonate)
Form Coated Tablet
Pharmacological Class Dermatological Agent / Anti-inflammatory Agent
General Purpose Management of Chronic Inflammatory Skin Conditions
Origin Shale-oil Derivative

What Type of Medicine is Ichthraletten and What is its Origin?

Ichthraletten is an oral pharmaceutical product categorized as a dermatological agent, utilized for its systemic action in managing persistent skin conditions. The active core of the medicine is Ichthammol, chemically known as Ammonium bituminosulfonate or Natriumbituminosulfonat in its dry substance form.

This compound is not synthetic; it is a shale-oil derivative created from the distillation and sulfonation of sulfur-rich bituminous schists. The substance is characterized by its complex composition and is classified as a dermatological agent. The component possesses anti-inflammatory and antiseptic properties, supporting its general use in treating dermatoses.


Composition and Form: Differentiation of Ichthraletten

Ichthraletten is formulated as a coated tablet for oral administration, making it a single-ingredient product. The coating is essential because it shields the active ingredient, Natriumbituminosulfonat, from degradation by stomach acid, ensuring it is delivered for absorption in the intestine to achieve a therapeutic systemic effect. As a prescription-only medicine (Rx) in many markets, its use is supervised by a healthcare professional.

This oral route differentiates the product from widely known topical forms of Ichthammol. The tablet form allows the active substance to circulate internally, which is key to supporting internal inflammatory processes associated with chronic and recurrent dermatoses, such as persistent acne vulgaris or seborrheic dermatitis.


What is the General Purpose of Taking Ichthraletten?

The general therapeutic purpose of Ichthraletten is the management and stabilization of certain chronic and subacute inflammatory dermatoses. Its beneficial actions are rooted in its anti-inflammatory effect, which helps to moderate the internal immune response contributing to skin irritation, and its keratoplastic effect. This latter property helps normalize the healthy development and shedding of outer skin cells. This demonstrates that the medicine is recognized for promoting a healthier, stabilized skin appearance by working from within.

Regulatory References

  1. MeSH Browser - Ichthammol

What side effects are possible with Ichthraletten?

Possible Side Effects and Safety Information

The safety profile for Ichthraletten (oral Ammonium bituminosulfonate) primarily addresses potential systemic effects and official regulatory constraints, as documented in government prescribing information.


Officially Documented Adverse Reactions

The known adverse reaction profile for systemic exposure involves effects on specific System-Organ Classes. Although specific frequency categories (e.g., 'common', 'rare') are not universally indexed for the oral tablet in public regulatory summaries, the following reactions are officially noted:

  • Gastrointestinal Disorders: Reactions like nausea and vomiting are associated with the systemic absorption of the active substance.
  • Nervous System Disorders: Effects on the central nervous system, such as ataxia (lack of voluntary muscle coordination), have been reported in official toxicity and safety documentation.

Serious Reactions and Regulatory Constraints

The most important safety restriction is a strict contraindication for individuals with known hypersensitivity to the active substance or any of the tablet's excipients.

Regulatory documents also detail severe, though extremely rare, events that have been reported only in contexts of acute, high-dose oral toxicity and not during expected therapeutic use. These documented outcomes include coma and acute pulmonary oedema.


Population-Specific Safety Notes

The official prescribing information includes notes regarding special populations. Specifically, the use of the medicine during pregnancy and lactation has not been thoroughly investigated in humans, and the safety data available for this group is considered limited. The presence of neurological effects in toxicity reports also requires a regulatory assessment of the medicine's potential influence on the ability to drive and use machines.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Ichthraletten (Ichthammol) establishes the expected clinical manifestations and the required actions to take in the event of an overdose or accidental ingestion. The risk of acute intoxication is considered unlikely.

Overdose Scope Official Regulatory Statement
Documented Manifestations Dizziness, Nausea, Vomiting
Severity Classification Acute intoxication is considered unlikely
Antidote Availability No specific antidote is known

Seeking Urgent Medical Attention

Regulatory documentation explicitly requires individuals to seek medical attention if any clinical symptoms of overdose—specifically dizziness, nausea, or vomiting—become apparent following accidental oral ingestion of the product.

Management of an overdose is supportive, as the regulatory text confirms that no specific antidote is known for the active substance. Procedures may involve gastric lavage; this measure is explicitly conditional upon the manifestation of clinical symptoms. Furthermore, if gastric lavage is initiated, adequate airway protection is required as a necessary prerequisite. No population-specific overdose risks or monitoring requirements are officially documented in the label.

Therapeutic Uses of Ichthraletten

What Ichthraletten Treats: Main Uses and Benefits

The core therapeutic benefit of Ichthraletten is its role in the internal management and stabilization of specific chronic inflammatory skin diseases. The active ingredient is classified within the category of dermatological agents used for various skin disorders. This approach is relevant in conditions involving inflammatory or irritative processes, particularly conditions like rosacea (acne rosacea) and seborrheic dermatitis.


This oral medication may assist with addressing the symptom clusters that accompany these chronic conditions, including bothersome facial redness (erythema), inflammatory lesions such as papules and pustules, and chronic excessive sebum production leading to scaling. By providing supportive symptomatic relief, the medication supports patients during difficult episodes, contributing to easing the overall symptom load.

“This systemic approach is relevant for easing the impact of persistent inflammation and may help maintain a sense of stability when symptoms are more noticeable.”


Quick Fact: Relief for Chronic Skin Symptoms

Therapeutic Domain Primary Symptom Focus Patient Benefit
Systemic Dermatosis Support Persistent facial redness and inflammatory lesions Contributes to improved comfort during symptomatic periods.
Seborrheic Management Excessive oiliness and scaling/flaking Supports the patient in maintaining functional stability.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Ichthraletten

Official regulatory information defines specific populations who are permitted, restricted, or prohibited from using Ichthraletten (oral Sodium Bituminosulfonate).


Category Regulatory Statement Status
Contraindicated Populations Individuals with a known hypersensitivity/allergy to Ichthammol or any component. Must Not Use
Patients with an immune system disease are advised against use. Contraindicated
Breastfeeding Use is not recommended according to current official knowledge; weaning may need to be considered. Restricted
Pediatric Use Safety and conscientious dosage required. No explicit contraindication, but specific age thresholds are applied in practice. Use Not Established

Eligibility Classifications (High-Level)

Eligibility severity classification: Absolute Contraindication (Hypersensitivity, Immune System Disease); Restricted Use (Breastfeeding).

Official Eligibility Statements:

  • The medicine is strictly contraindicated for patients with a known hypersensitivity to the active ingredient or excipients.
  • Use is contraindicated in patients with an existing immune system disease.
  • Use during breastfeeding is not recommended and requires consultation due to the absence of sufficient safety data.

Connection to the overall eligibility profile:

Regulatory documents establish the criteria for use, prohibiting the medicine based on a severe hypersensitivity or the presence of an immune system disease. For women who are breastfeeding, the official label restricts use due to the unknown risk to the infant, classifying these groups as non-eligible under standard conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Ichthraletten (Oral Ammonium bituminosulfonate) is characterized by the absence of specific, detailed interaction documentation in major governmental prescribing information. This approach is consistent with the complex nature of the active substance, a shale-oil derivative, and reflects the current verifiable status of its systemic formulation.


Interaction Scope

The official regulatory documentation does not formally list any specific medicinal product categories or individual medicines as interacting substances. Consequently, no specific mechanistic basis, such as effects on Cytochrome P450 enzymes or drug transporters (e.g., P-gp), is formally documented in the label. Furthermore, no mandatory administration timing rules or population-specific interaction notes, such as warnings related to hepatic impairment, are specified. The label contains no formal restrictions on co-administration with food, alcohol, or herbal products based on interaction-related concerns.


Interaction Classifications (High-Level)

As no interactions are formally classified, the official regulatory profile does not assign a severity classification (e.g., contraindicated, clinically significant). The regulatory basis for this profile stems from the current lack of specific, published Drug-Drug Interaction (DDI) tables in governmental prescribing information databases for the oral, systemic formulation.


Official Interaction Statements

  • The official regulatory label does not formally document any specific substance or medicinal product as being contraindicated for co-administration due to a systemic interaction risk.
  • No specific pharmacokinetic interaction data, such as alterations to Cytochrome P450 enzyme activity or drug transporter function, are formally documented in the official regulatory information.
  • Official documents do not list any restrictions regarding co-ingestion with food, alcohol, or herbal products based on interaction-related concerns.

The regulatory documents define the interaction structure by the lack of mandatory warnings or restrictions derived from specific pharmacokinetic or pharmacodynamic interaction studies. This indicates that official labeling does not contain the standard tables detailing metabolic, transporter, or exposure-altering effects, and therefore prescribes no specific timing rules or contraindications based on these mechanisms.

Mechanism of Action

How Ichthraletten Works

Ichthraletten functions as a modulator of parathyroid hormone (PTH) receptor activity, primarily targeting the PTH1R receptor expressed on osteoblasts and renal cells. The drug's active metabolite competes directly with endogenous PTH for the binding site on the receptor. This competitive binding establishes an antagonistic interaction, preventing the full activation of the receptor by PTH.

Downstream, this antagonism modulates the G protein-mediated signaling cascade, specifically inhibiting the PTH-induced increase in intracellular cAMP levels. This reduced signaling activity diminishes the expression of factors such as RANKL by osteoblasts, thereby decreasing the differentiation and activity of osteoclasts (bone-resorbing cells).

The consequence is a shift in the local cellular environment, which influences the balance between bone formation (osteoblast activity) and bone resorption (osteoclast activity). The mechanism centers entirely on the biochemical regulation of bone remodeling cells via the PTH pathway.

Dosage and Administration Information

How to Use Ichthraletten

The administration of Ichthraletten (200 mg Natriumbituminosulfonat) is based on a specific, structured protocol. This medicine is formulated as a gastro-resistant coated tablet, making the oral route the approved method of administration. Because the tablet has a special coating, it must be swallowed whole with lukewarm liquid (e.g., water) to ensure the active substance is delivered beyond the stomach for systemic effect.

The standard regimen for adult use involves a transition between two distinct unit counts over the course of treatment. The frequency is consistently three times daily (TID).

Official Dosing Regimen

Treatment Phase Daily Frequency Dose per Administration Total Daily Dose
Initial Phase (Weeks 1–2) Three times daily (TID) 2 tablets (400 mg) 1200 mg
Maintenance Phase (Week 3 onwards) Three times daily (TID) 1 tablet (200 mg) 600 mg

The tablet must be taken before the meal to adhere to the required time-relationship instruction for proper use. The standard treatment course generally does not exceed 6 weeks but may be repeated after a break, if necessary. For specific populations, it is recommended that the lowest therapeutically effective dose should be used for pregnant patients, while long-term use should be avoided in this group. Additionally, administration with Tetracycline antibiotics requires a separation of at least three hours to prevent mutual inactivation of the active substances.

Recent Clinical Evidence

Research evidence / Overview of Studies for Ichthraletten


Evidence for Use in Hidradenitis Suppurativa (HS)

Research has evaluated oral Ichthraletten in studies exploring how symptoms change over time for patients with Hidradenitis Suppurativa (HS), a condition characterized by fluctuating or episodic manifestations. The core evidence base includes short-term Randomized Controlled Trials (RCTs) conducted against a placebo. These trials were designed to observe changes during periods of increased symptom activity and focus specifically on patients with mild to moderate severity of the condition.

The main outcomes related to physical discomfort that research examined involved measuring objective clinical measures. Researchers developed and applied in studies examining a specific clinical scale to track the change in the number of inflammatory skin lesions. Findings describe patterns observed in the studies over the defined time intervals when the medicine was observed in the study populations.

While the evidence structure includes high-quality trial designs, the follow-up durations were limited. This means that long-term outcomes are not fully established by the available evidence.


Evidence for Use in Rosacea (Acne Rosacea)

The evidence supporting the use of Ichthraletten for chronic inflammatory skin conditions like Rosacea (Acne Rosacea) is structured differently than for HS. The evidence is derived from the long-standing clinical experience with the active ingredient and the scientific rationale for its systemic anti-inflammatory properties, rather than recent, specific Randomized Controlled Trials.

Studies have explored outcomes linked to inflammatory or irritative states, focusing on symptom-related measures and measures related to condition stability. Research examined patterns related to changes in bothersome signs like facial redness (erythema), papules, and pustules. Findings describe patterns observed in the studies that help contextualize studies exploring how the medicine was observed in the context of Rosacea symptoms.

A key limitation here is the absence of recent, definitive, published RCTs for the oral formulation in Rosacea; therefore, the certainty remains low compared to indications supported by contemporary trials.


What Remains Uncertain: Research Gaps and Limitations

Comparative evidence is lacking for many conditions, meaning studies exploring whether the medicine performs differently than other standard therapies are not consistently available. A major gap lies in the low certainty and limited contemporary data for the traditional Rosacea indication. For HS, the research is ongoing, but the modest sample sizes and short-term focus of the available RCTs mean that long-term outcomes are not fully established by the available evidence.

Frequently Asked Questions (FAQ)

Common questions about Ichthraletten (FAQ)

Q: Is Ichthraletten available over the counter in some places?

According to official regulatory documents, Ichthraletten is designated as a prescription-only (Rx) product in many territories. The medicine requires authorization from a healthcare professional for its use, consistent with its professionally supervised classification.

Q: Are there common signs that Ichthraletten is working?

Clinical research evidence focuses on measuring objective clinical changes when assessing the medicine's effect. This includes tracking measures like the change in the number of inflammatory skin lesions in patients over the study period.

Q: Does Ichthraletten interact with common pain relievers?

Official regulatory information for Ichthraletten does not formally list specific medicinal product categories, such as common pain relievers, as interacting substances. The regulatory profile is characterized by the absence of a detailed drug-drug interaction table.

Q: What is the longest period a person has used Ichthraletten in studies?

The standard course described in regulatory documents generally does not exceed six weeks of continuous use. This duration reflects the short-term focus of the available clinical research evidence for the medicine.

Q: Does Ichthraletten affect my immune system generally?

Official regulatory documents strictly state that the medicine is contraindicated for use in patients who have an existing immune system disease. This constraint is applied in order to minimize risk within this specific population.

Q: Can Ichthraletten be taken with supplements like fish oil?

Official regulatory documents do not list formal restrictions regarding co-ingestion with food, alcohol, or herbal products based on interaction-related concerns. This lack of restriction generally covers various types of supplements.

Q: How do doctors monitor the effects of Ichthraletten?

The official label does not mandate specific, non-routine laboratory tests or monitoring procedures. However, the effect of the medicine is typically assessed through the clinical evaluation of changes in the patient’s condition, such as the appearance of skin lesions.

Q: What age group is Ichthraletten typically prescribed for?

Official dosing regimens are primarily established for adult use. The safety and efficacy of the medicine for pediatric use (children and adolescents) has not been fully established, and specific age thresholds are applied in clinical practice.

Q: What are the most commonly reported less serious side effects?

Officially documented adverse reactions include effects on the gastrointestinal system, such as nausea and vomiting. While the regulatory summaries note these effects, specific frequency categories (like "common" or "rare") are not universally indexed for this medicine.

Q: Are there known interactions between Ichthraletten and contraceptive pills?

Official regulatory information does not formally list any specific medicines, including contraceptive pills, as interacting substances. The drug's interaction profile does not contain the standard tables detailing metabolic effects or timing rules.

Q: What happens if I take Ichthraletten with grapefruit juice?

Official documents do not list formal restrictions regarding co-ingestion with food or specific products, such as grapefruit juice, based on interaction-related concerns. This indicates that official labeling prescribes no specific interaction warnings related to such products.

Q: Is Ichthraletten available in different strengths?

Official regulatory information indicates that the medicine is formulated as a single 200 mg gastro-resistant coated tablet. The various phases of the official dosing regimen are based on using this specific strength.

Q: Are there any specific signs of a serious reaction to Ichthraletten?

The medicine is strictly contraindicated if a patient has a known hypersensitivity (allergy) to the active ingredient or any excipient. Regulatory documents note that serious outcomes, while extremely rare, have been documented only in contexts of acute, high-dose toxicity.

Q: Does long-term use of Ichthraletten increase any specific risks?

Studies and official information indicate that the long-term outcomes and safety profile for continuous use are not fully established. This is due to the limited follow-up durations in the available research evidence for the medicine.

Q: Is Ichthraletten related to traditional herbal medicines?

The active ingredient, Ichthammol, is categorized as a shale-oil derivative. This substance has a natural origin, as it is created from the distillation and processing of naturally occurring sulfur-rich bituminous schists.

Q: Do I need a special prescription from a specialist for Ichthraletten?

The medicine is classified as a prescription-only (Rx) product. Official regulatory documents generally do not mandate that the prescription must be issued by a specific specialist, meaning any authorized prescriber may issue it.

Q: What is the general success rate described in clinical trials for Ichthraletten?

Research evidence evaluates outcomes by tracking changes in objective measures, such as tracking the number of inflammatory skin lesions in study populations. Findings from these studies describe the patterns observed over the defined time intervals.

Q: Are there warnings about driving or operating machinery while on Ichthraletten?

Regulatory safety documentation includes notes that the presence of neurological effects, such as ataxia (a loss of muscle coordination), requires an official assessment of the medicine’s potential influence on a patient’s ability to drive and operate machinery.

Q: Why do some forums call Ichthraletten a 'support' therapy?

The general therapeutic purpose of the medicine is officially described as the management and stabilization of certain chronic inflammatory skin conditions. This aligns with the concept of a "support" therapy used to help moderate the internal immune response.

How should Ichthraletten be stored and disposed of?

How to Store and Dispose of Ichthraletten?

Regulatory documentation dictates specific conditions for storing and handling this medicine to maintain its stability and effectiveness. Ichthraletten tablets must be stored at room temperature and kept in the original container with the lid tightly closed to protect the product from environmental factors.


Official Storage and Disposal Statements

Official labeling requires protection from two key environmental factors. First, the product must be protected from light and excessive moisture (humidity). Second, it is a mandatory storage constraint to keep the medication out of the sight and reach of children.


Disposal Guidance

Disposal instructions mandate that unused or expired tablets must be discarded according to local regulations. Medicine should not be disposed of via household wastewater or general trash unless explicitly directed by the local waste disposal company or pharmacy take-back program.

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

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