Berlithion 300

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Berlithion 300

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Berlithion 300

Property Description
Active Ingredient Thioctic Acid (alpha-Lipoic Acid)
Forms Oral solids (Capsules, Tablets), Sterile liquid solution
Pharmacological Class Antioxidant, Metabolic Regulator, Vitamin-like substance
Common Use Supporting metabolic and nervous system function
Origin Synthetic, mirrors the endogenous compound

Defining Berlithion 300: Active Ingredient and Pharmacological Class

Berlithion 300 is a pharmaceutical preparation marketed by Berlin-Chemie/Menarini Pharma, containing Thioctic Acid, which is chemically identical to the naturally occurring substance known as alpha-Lipoic Acid (ALA). The drug is primarily classified as an antioxidant and a metabolic regulator, often recognized as a vitamin-like substance due to its essential biological role. Alpha-Lipoic Acid is an organosulfur compound that acts as an essential cofactor in mitochondrial enzyme systems.

The foundational component, Thioctic Acid, is synthesized for pharmaceutical use, but it mirrors the compound endogenously (naturally) produced within the body, which is vital for cellular energy processes. Its pharmacological classification is rooted in its ability to support and regulate these critical metabolic pathways and cellular defense mechanisms.

Composition and Available Pharmaceutical Forms

Berlithion 300 is a single-component product focused exclusively on delivering therapeutic amounts of Thioctic Acid for systemic action. This brand is clinically recognized for its availability in multiple forms, distinguishing it from products limited to only oral intake. The preparation is typically available as oral solids, such as hard gelatin capsules or film-coated tablets. It may also be supplied as a sterile liquid formulation designed for intravenous (IV) route of administration.

The availability of different forms—oral and a solution suitable for injection—ensures that the Thioctic Acid can be administered flexibly. In both final dosage forms, the active substance is combined with inert pharmaceutical carriers, which ensures the stability and effective delivery of the drug into the body.

General Purpose and Cellular Function of Thioctic Acid

The general purpose of this medicine is to protect cells from damage and to support the efficiency of vital energy-producing processes. Thioctic Acid is distinguished by its ability to neutralize highly reactive molecules known as free radicals across all parts of the cell, acting as a master antioxidant.

Furthermore, the compound is an indispensable cofactor that ensures the efficiency of key enzymes responsible for converting sugars and fats into energy. This combined protective and metabolic capability is directed at stabilizing and improving the function of high-demand tissues, serving as general support for metabolic and neurological health.

Regulatory References

  1. Alpha-Lipoic Acid - StatPearls - NCBI Bookshelf
  2. Alpha-Lipoic Acid: MedlinePlus Supplements

What side effects are possible with Berlithion 300?

Possible Side Effects and Safety Information

The information regarding the safety profile of Berlithion 300 (Thioctic Acid or alpha-Lipoic Acid) is based strictly on authoritative government regulatory documents, such as the Summary of Product Characteristics (SmPC) and equivalent government-approved labeling.

Documented Adverse Reactions by Frequency

Adverse effects are categorized by frequency as documented in regulatory data. The most Common effects are generally related to the gastrointestinal and nervous systems.

Frequency Category Examples of Adverse Reactions (by SOC)
Common Nausea, Vomiting, Headache, Dizziness
Rare Allergic skin reactions (Rash, Urticaria)
Very Rare Anaphylactic Reaction, Severe Hypoglycemia, Dyspnoea
Not Known Diarrhea, Abdominal pain, Visual impairment (mainly IV)

Serious Adverse Reactions and Risk Groups

Regulatory documents highlight rare but clinically significant adverse reactions and specific usage constraints:

  • Serious Reactions: Rare but severe adverse reactions include Anaphylactic Reaction (a severe allergic event) and Severe Hypoglycemia (a significant drop in blood sugar), which are documented as Very Rare.
  • Children and Adolescents: The medicine is contraindicated (should not be used) in children and adolescents due to a lack of sufficient clinical safety data.
  • Diabetic Patients: Close monitoring of blood glucose levels is required for diabetic patients. This is necessary because Thioctic Acid may enhance the effects of blood-glucose-lowering agents, increasing the risk of hypoglycemia, particularly at treatment initiation or dose adjustment.
  • Administration Risk: The risk of Anaphylactic Reaction is noted to be higher following rapid intravenous (IV) administration.

All use must be strictly according to regulatory guidelines and dosage instructions provided by the prescribing professional.

Overdose and Emergency Response

Overdose and when to seek help

Berlithion 300 overdose may lead to severe, acute poisoning characterized by serious central nervous system and metabolic disturbances. The documented initial manifestations often include nausea, vomiting, and headache, which can escalate to more severe presentations such as seizures with loss of consciousness and altered mental status.

Physiological systems potentially affected, as described in official regulatory documents, include the metabolic system, where severe hypoglycemia and high lactic acid concentrations leading to metabolic acidosis are possible. The official overdose profile lists severe systemic outcomes such as multiple organ dysfunction, rhabdomyolysis (muscle damage), disturbances of blood clotting (coagulopathy), hemolysis, and circulatory collapse leading to shock.

A significant overdose of Thioctic Acid is classified as a severe medical emergency. Regulatory bodies mandate that individuals must seek immediate medical attention and arrange for prompt transportation to the hospital for any suspected poisoning. The need for urgent care is reinforced by the fact that no specific antidote is known for this intoxication.

Management is strictly based on symptomatic and supportive treatment following general principles for poisoning cases. Special considerations are documented for the pediatric population, which carries an increased risk of severe, potentially lethal outcomes, and for adult exposures involving concurrent excessive alcohol use.

Therapeutic Uses of Berlithion 300

What Berlithion 300 Treats: Main Uses and Benefits

The core therapeutic application of Berlithion 300 is focused on providing supportive symptomatic relief for Diabetic Polyneuropathy (DSPN), a common neurological complication in patients with diabetes. This medication is commonly used across therapeutic domains where additional symptomatic support is needed to address significant patient distress. The compound is considered relevant in the management of this condition.

Berlithion 300 is relevant for easing symptom clusters that may become intense or disruptive, specifically addressing neuropathic pain, burning sensations, tingling, and the progressive feeling of numbness. This supportive relief supports improved day-to-day comfort during periods of heightened symptoms.

Therapeutic Focus and Benefits

Berlithion 300 is primarily used in clinical settings that involve the chronic and often progressive symptoms of nerve damage related to metabolic conditions. The core therapeutic benefit is to provide support that helps ease the overall symptom burden associated with chronic nerve impairment, assisting with functional comfort when symptoms interfere with routine activities.

Quick Fact: Relief for Painful Neuropathy
The medication is commonly used in conditions presenting with symptoms such as shooting pain or burning in the extremities, supporting patients during periods of heightened discomfort.

Eligibility and Restrictions for Use

Berlithion 300 (containing alpha-lipoic acid or thioctic acid) is not suitable for all patient groups and carries specific usage restrictions defined by regulatory bodies.

Populations that Must Not Use Berlithion 300

  • Contraindication (Prohibited): Individuals with known hypersensitivity (allergy) to the active substance, alpha-lipoic acid (thioctic acid), or any of the product's excipients.

Groups for Whom Use is Restricted or Not Recommended

Population/Condition Eligibility Status Regulatory Requirement
Children and Adolescents Not Recommended Use is not established due to a lack of reliable clinical data in this age group. High doses have been associated with severe toxicity, including seizures.
Lactation (Breastfeeding) Avoid Use There is insufficient reliable data regarding the safety of the substance's secretion into breast milk.
Pregnancy Special Consideration Use during pregnancy requires caution and medical advice. While some studies suggest possible safety at limited doses (up to 600 mg/day) for short periods, a risk-benefit assessment by a healthcare professional is mandatory.
Specific HLA Genotypes Special Consideration Individuals with the HLA-DRB104:06 and HLA-DRB104:03 alleles are more susceptible to developing Insulin Autoimmune Syndrome (IAS) when treated with alpha-lipoic acid.

Clinical States Requiring Caution

Use requires special monitoring and caution in patients with diabetes mellitus (due to the risk of hypoglycemia), a history of thyroid disorder (due to possible reduced effectiveness of thyroid hormone), or thiamine deficiency (often seen in heavy alcohol users).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Thioctic Acid (Berlithion 300) defines interaction patterns primarily through pharmacodynamic effects and physicochemical chelation.

Interaction Type Interacting Substance/Class Official Interaction Statement
Pharmacodynamic Antidiabetic Agents (e.g., Insulin, Oral Drugs) Co-administration may result in an additive blood-glucose-lowering effect, increasing the risk of hypoglycemia.
Cisplatin (Cytotoxic Agent) The official labeling documents a potential reduction in the efficacy of Cisplatin due to the antioxidant properties of Thioctic Acid.
Exposure-Altering Metal Cation Compounds (e.g., Iron Salts, Calcium-rich foods) Oral administration of these agents causes a physicochemical reduction in the absorption and bioavailability of Thioctic Acid.

This interaction structure necessitates specific administration constraints. Regulatory documents include mandatory timing-based interaction rules, stipulating that oral Thioctic Acid must be taken separately from products containing metal cations, such as iron preparations or dairy products, to ensure sufficient absorption. The interaction profile also includes a restriction concerning lifestyle substances: the consumption of alcohol is officially documented to counteract the therapeutic effect of Thioctic Acid, particularly in the treatment of polyneuropathy. The regulatory data does not explicitly state interactions based on CYP enzyme inhibition or transporter effects.

Mechanism of Action

Mechanism of Action: Berlithion 300

Berlithion 300 (Alpha-Lipoic Acid) functions as an amphiphilic scavenger of Reactive Oxygen Species (ROS) across both aqueous and lipid cellular compartments. Its reduced form, Dihydrolipoic Acid (DHLA), is involved in the reduction of oxidized endogenous antioxidants, such as Vitamin C and E, contributing to the maintenance of the cellular antioxidant network. This redox cycling results in decreased systemic oxidative stress and reduced lipid peroxidation, influencing the integrity of cell membranes and structures.

The drug is a signal transduction modulator, primarily inhibiting the activation of the pro-inflammatory factor NF-κB and activating the Nrf2 pathway. This action limits the genetic expression of pro-inflammatory cytokines while affecting the synthesis of antioxidant enzymes. The resulting physiological effect is a broad attenuation of chronic inflammatory processes.

Due to its ability to cross the blood-brain barrier, the drug exerts effects in both the Central and Peripheral Nervous Systems. Furthermore, it modulates energy metabolism by activating AMPK, which facilitates the non-insulin-dependent uptake of glucose into peripheral cells. These mechanisms result in modulation of nerve impulse transmission and altered peripheral glucose utilization, affecting the physiological state of nerve and vascular function.

Dosage and Administration Information

Official Administration Guidelines

Berlithion (alpha-lipoic acid or thioctic acid) use is structured into two distinct phases, each requiring a specific dosage form and administration method.


Dosing Phases and Routes

Treatment Phase Dosage Form & Route Standard Frequency
Intensive Solution for Intravenous (IV) Infusion Once Daily
Maintenance Oral Capsules/Tablets (e.g., 300 mg or 600 mg) Once Daily

Administration Requirements

1. Intravenous (IV) Infusion (Intensive Phase)

For the intensive phase, the solution must be administered via a slow IV infusion, typically over a period of at least 30 minutes. The concentrate requires dilution before use. Crucially, the prepared infusion solution must be protected from light during the entire administration process, often by using light-protected materials.

2. Oral Administration (Maintenance Phase)

Oral administration is reserved for the maintenance phase. The capsules or tablets must be swallowed whole with sufficient liquid. To ensure optimal absorption, the dose must be taken on an empty stomach, generally 30 minutes before the first meal of the day.

3. Population Constraints

Berlithion is generally not recommended for use in children and adolescents due to a lack of comprehensive clinical data in these age groups.

4. Missed Dose

If an oral dose is missed, it should not be compensated for by taking a double dose. Patients should simply continue with the next scheduled dose at the usual time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Berlithion 300


Evidence for Symptomatic Diabetic Polyneuropathy (DSPN)

The primary research for Berlithion 300 (Thioctic Acid) has focused on research examining conditions such as Diabetic Polyneuropathy (DSPN), a condition characterized by fluctuating or episodic symptoms like pain, tingling, and burning in the limbs. Research has explored conditions where symptoms may vary in intensity. Studies largely consist of Randomized Controlled Trials (RCTs) and systematic reviews that synthesize those trial findings. This type of research was designed to monitor how symptoms evolved in the observed populations during defined time intervals.

In these studies, researchers monitored patient-reported outcomes describing perceived discomfort. They used specific tools, such as the Total Symptom Score (TSS), which is used in research exploring how symptoms change over time in the observed populations. Findings describe patterns observed in the studies related to measurements taken for these neuropathic symptoms. These research reports highlighted changes measured during the study period, helping to contextualize how patients reported their experience during periods of heightened symptom activity.


Comparison of Administration Routes in Research

Research examined both the sterile liquid formulation, which requires intravenous (IV) administration, and the oral forms (tablets or capsules). Data show patterns related to how rapidly symptoms were monitored to change in the short-term intravenous setting compared to the oral setting. Some trials described patterns that were observed in outcomes related to physical discomfort with the intravenous approach. The outcomes are not directly comparable, and evidence quality varies across studies depending on the route of administration being observed.


Research Gaps and Areas of Scientific Uncertainty

Despite the existing body of research, certainty remains low in several key areas. The main evidence gaps relate to the long-term impact and durability of any observed response, particularly with the standard oral dosage form. Systematic reviews described that long-term effects are not fully established, and findings were mixed regarding continued patterns over extended timeframes. Data for certain groups, such as children or adolescents, remain insufficient, and the results apply only to the adult populations studied in the major trials.

Key Studies & References

  1. Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III study)
  2. Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial
  3. Alpha-Lipoic Acid in Diabetic Peripheral Neuropathy: Addressing the Challenges and Complexities Surrounding a 70-Year-Old Compound (Review discussing gaps and long-term data)

Frequently Asked Questions (FAQ)

Common questions about Berlithion 300 (FAQ)


Q: Does Berlithion 300 only treat symptoms, or does it also address the underlying cause of nerve damage?

Official information describes that the mechanism of Berlithion 300 involves reducing oxidative stress and modulating inflammation. These processes are believed to be underlying factors in the development of nerve damage. However, regulatory-cited clinical studies have primarily focused on measuring improvement in symptoms such as pain and tingling.


Q: What are the reported side effects specific to the nervous system from Berlithion 300?

According to the official product information, common side effects affecting the nervous system include headache and dizziness. Visual impairment has also been documented, though this effect is mainly associated with intravenous (IV) administration.


Q: Does Berlithion 300 interact with medications used for cancer treatment?

Regulatory documents explicitly state that co-administration may reduce the efficacy (effectiveness) of the cytotoxic agent Cisplatin, a type of medication used in cancer treatment. Official labeling only specifies interaction data for Cisplatin, and no other cancer medications are explicitly detailed.


Q: What is the known interaction between Berlithion 300 and thyroid hormone medications?

The official product information notes that Thioctic acid may reduce the effectiveness of thyroid hormone medications. Because of this, caution and monitoring are required for patients with thyroid disorders.


Q: Does Berlithion 300 affect the effectiveness of blood thinners (anticoagulants)?

Official interaction databases generally state that no established interaction has been found between alpha-lipoic acid and common oral blood thinners. Official review of the product does not indicate an established interaction with common oral blood thinners.


Q: Does the effect of oral anti-diabetic tablets change when taking Berlithion 300?

Regulatory documents state that co-administration results in an additive blood-glucose-lowering effect, which increases the risk of low blood sugar (hypoglycemia).


Q: What is the usual duration of treatment with Berlithion 300?

Treatment is structured into an initial Intensive Phase using IV Infusion, followed by a Maintenance Phase using oral tablets or capsules. Specific treatment timelines for each phase are not fixed in the general regulatory instructions, and decisions regarding duration are individualized.


Q: Is the improvement in nerve symptoms permanent after stopping the medicine?

Regulatory-cited research and reviews have noted that the long-term durability and impact of the observed response, particularly after the oral treatment is stopped, are not fully established. Existing evidence primarily describes the effects observed while the medicine is actively being used.


Q: Can Berlithion 300 help with other types of nerve pain besides diabetic neuropathy?

The medication is formally indicated in regulatory documents for the symptoms of diabetic polyneuropathy (DSPN). The established indications do not include use for other types of nerve pain.


Q: Is Berlithion 300 considered a prescription drug in all countries?

The active ingredient, Alpha-Lipoic Acid, is classified differently around the world. In various countries, it is available as both a pharmaceutical drug requiring a prescription and a non-prescription dietary supplement. This difference in classification results in varying regulatory statuses.


Q: Are there any general signs of overdose that official sources describe?

Official regulatory documents describe several signs associated with severe overdose, which include generalized convulsions, lactic acidosis, and a severe drop in blood sugar known as hypoglycemia.


Q: Can people with liver disease use Berlithion 300?

Regulatory information advises patients with liver disease to consult with a healthcare professional before using the medication. This is based on the need for caution and review of individual health status before use.


Q: Can the medicine affect the ability to drive or operate machinery?

Official regulatory text states that due to side effects such as dizziness, the drug may potentially affect the ability to drive or operate machinery.


Q: What is the purpose of the '300' in the drug name Berlithion 300?

The number '300' typically refers to the strength (300 mg) of the active substance, Thioctic Acid, contained within that specific dosage form, such as a capsule or tablet.


Q: What is the meaning of paresthesia in the official documents for Berlithion 300?

Paresthesia is the medical term used in the official documents to describe the unpleasant symptoms the drug is used to treat. These sensations are typically described as tingling, prickling, or numbness associated with polyneuropathy (nerve damage).


Q: Have official clinical studies been conducted on the long-term safety of Berlithion 300?

While evidence for the drug's effectiveness often focuses on short-term trials, the general regulatory review process covers long-term safety monitoring. This includes post-marketing surveillance and risk management, which are required to ensure the drug's safety profile is continuously evaluated.


Q: Why is the medicine sometimes mentioned in discussions about other neurological conditions like MS?

The drug's chemical properties, specifically its role as an antioxidant and its ability to cross the blood-brain barrier, make it a subject of research. This research explores its potential in various neurodegenerative conditions, although it is not officially indicated for them.


Q: Is Berlithion 300 absorbed better if taken on an empty stomach?

Official administration guidance recommends the drug be taken on an empty stomach. This method is recommended to help ensure optimal absorption and maximize the bioavailability (how much of the drug reaches the bloodstream) of the active substance.


Q: How does the oral capsule form differ from the liquid or injectable forms in terms of effect?

Regulatory guidance dictates that the IV infusion is generally used for the initial intensive phase of treatment to achieve rapid therapeutic levels. Conversely, the oral form is designated for the maintenance phase to sustain the effect over a longer period of time.


Q: Is it common for doctors to adjust the dose of diabetes medication when starting Berlithion 300?

Regulatory documents explicitly require close monitoring of blood glucose levels when starting treatment. They state that in individual cases, a reduction in the dose of insulin or oral antidiabetic agents may be needed due to the drug’s additive effect on blood sugar.

How should Berlithion 300 be stored and disposed of?

How to Store and Dispose of Berlithion 300?

Official regulatory guidelines define specific storage and disposal requirements to maintain the integrity of Berlithion 300 (Thioctic Acid).

Official Storage Constraints

Requirement Constraint (Regulatory Rule)
Temperature Store at or below 25 C (Controlled room temperature).
Light Protection Keep the medicine in its original outer carton to protect the photosensitive content from light.
Handling The medicine must be kept out of the sight and reach of children.
Stability Do not use the medicine after the expiry date printed on the packaging.

Disposal Instructions

Medicines should not be disposed of via household waste or wastewater (e.g., down the sink or toilet). Unused or expired Berlithion 300 must be discarded according to local environmental regulations, typically by returning the product to a pharmacist or an approved pharmaceutical take-back scheme.

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

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