Katadolon

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Katadolon

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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 Katadolon

Quick Facts

Property Description
Active ingredient Flupirtine maleate
Form Oral capsules (immediate and sustained-release)
Pharmacological class Analgesic (Non-Opioid, Centrally Acting)
Common use Management of moderate to severe pain
Origin Synthetic compound (aminopyridine derivative)

The Definitive Identity: What Type of Analgesic is Katadolon? (Centrally Acting)

Katadolon is a prescription-only medicine (Rx) containing the active substance Flupirtine maleate, which is a synthetic aminopyridine derivative. It is classified under the WHO Anatomical Therapeutic Chemical (ATC) system as a centrally acting, non-opioid analgesic. This designation means the drug achieves its primary pain-relieving effects within the central nervous system (CNS), specifically the brain and spinal cord, distinguishing its pharmacological profile from common anti-inflammatory medications. This positioning provides a therapeutic alternative for managing significant pain when traditional analgesics are unsuitable.

Composition and Form: What are Katadolon Capsules? (Origin and Delivery)

Katadolon is a single-ingredient product, confirming that Flupirtine maleate is the only active component. As a synthetic compound, it is administered via the oral route in hard capsules. The product is available in both standard immediate-release capsules and sustained-release capsules, which are engineered to release the compound over a longer period. This provides flexibility for managing pain that requires either rapid intervention or consistent, extended action. Its action is independent of opioid receptors and traditional anti-inflammatory pathways, which characterizes the drug's non-narcotic nature.

Unique Action: How Does Flupirtine Work Generally? (High-Level Mechanism Summary)

Flupirtine operates through a method of regulating the electrical excitability of nerve cells in the CNS to reduce the transmission of pain signals. Its primary function is that of a Selective Neuronal Potassium Channel Opener (SNEPCO), a mechanism that stabilizes nerve membranes and decreases their tendency to propagate pain messages. This specific central effect offers pain reduction and is also associated with a secondary effect: the easing of associated muscle tension.

Regulatory References

  1. supported by the National Institutes of Health

What side effects are possible with Katadolon?

Possible Side Effects and Safety Information (Regulatory Overview)

Katadolon ( Flupirtine maleate) has a safety profile that is explicitly defined by regulatory bodies, with the primary concern focused on hepatotoxicity. All reported adverse reactions are classified according to official frequency categories, consistent with regulatory standards.

Frequency-Classified Adverse Reactions

The most commonly observed adverse reaction is categorized as Very Common, while other effects are noted in lower frequency bands:

  • Very Common: Increase in liver enzymes (e.g., elevated transaminases).
  • Common: Adverse reactions primarily affecting the Nervous System (e.g., dizziness, drowsiness) and Gastrointestinal tract (e.g., nausea, dry mouth) have been historically documented.
  • Frequency Not Known: Serious adverse reactions, including hepatitis and life-threatening liver failure, have been reported in post-marketing surveillance, sometimes leading to liver transplantation.

Official Safety Constraints and Restrictions

The potential for liver injury dictates strict constraints on the medicine's use, as documented in regulatory texts:

  • Mandatory Duration Limit: Due to the risk of cumulative exposure, the official prescribing information mandates that the duration of treatment must not exceed two weeks for the management of acute pain.
  • Contraindications: Use is strictly prohibited (contraindicated) in individuals with severe hepatic impairment, pre-existing liver disease, or conditions like hepatic encephalopathy.
  • Population Note: The safety and effectiveness of the medicine have not been established for use in children and adolescents under the age of 18 years, leading to a typical restriction of use to the adult population.

Overdose and Emergency Response

Overdose and when to Seek Help

The information below summarizes the officially documented descriptions of overdose for Flupirtine maleate (Katadolon), based strictly on government regulatory sources.

Documented Overdose Manifestations

Overdose has been associated with specific clinical signs, primarily affecting the Central Nervous System (CNS) and gastrointestinal system. Documented overdose presentations include drowsiness (somnolence), nausea, vomiting, tachycardia (rapid heart rate), dry mouth, agitation, and altered consciousness.

Serious / Life-Threatening Outcomes: Regulators have identified the potential for severe systemic toxicity, including convulsions (seizures), respiratory depression, coma, and severe hepatic impairment (liver injury or failure).

Required Emergency Action

Immediate medical attention must be sought for any suspected overdose. The regulatory guidance explicitly mandates discontinuation of the product and transfer to a hospital for observation and management, given the risk of progression to life-threatening symptoms. Increased severity of manifestations is noted in patients with pre-existing hepatic impairment or renal impairment.

Supportive Management

No specific antidote is known for Flupirtine maleate toxicity. Management is restricted to symptomatic and supportive treatment, which may include procedures such as gastric lavage or the administration of activated charcoal, and requires intensive monitoring of vital functions and liver function tests.

Therapeutic Uses of Katadolon

What Katadolon Treats: Main Uses and Benefits

Katadolon (Flupirtine maleate) is a non-opioid, centrally acting analgesic generally used to provide symptomatic relief for symptoms related to physical discomfort that may be part of symptomatic management across various distressing conditions. This application includes its use across various distressing conditions as part of a therapeutic approach.

The medication is considered relevant across domains where additional symptomatic support is needed for symptoms that may become intense or disruptive, especially those associated with muscular activity. It is commonly used across conditions presenting with systemic or localized discomfort, or conditions involving episodic or fluctuating manifestations. It is also considered relevant in clinical contexts involving heightened systemic burden, such as following post-operative procedures or traumatic injuries, when supportive symptom management is appropriate. The medication plays a role in managing symptoms that interfere with daily comfort. The goal of treatment is to provide support that helps ease the overall symptom burden.


Quick Fact: Support for Pain and Muscle Tension

Property Description
Main Symptom Domain Symptoms related to physical discomfort.
Supportive Symptom Focus Symptoms of increased neurological or muscular activity.
Relevant Use Scenarios Conditions presenting with systemic or localized discomfort and acute or disruptive episodes.
Therapeutic Support Goal Assists with maintaining functional stability and offers symptomatic relief that helps patients cope more steadily.

Eligibility and Restrictions for Use

Official Population Eligibility for Katadolon (Flupirtine maleate)

Katadolon use is subject to strict limitations and absolute contraindications as defined in official regulatory labeling. Use is generally restricted to adults for the treatment of acute pain only, and treatment must not exceed 14 days (two weeks).

Who Must Not Use Katadolon (Contraindications)

The medicine is absolutely contraindicated (must not be used) in patients with the following conditions:

  • Pre-existing liver disease (hepatic insufficiency or active liver conditions).
  • Myasthenia gravis.
  • Known hypersensitivity to flupirtine maleate.

Age and Condition Limitations

Population Group Regulatory Status
Children and Adolescents (Under 18) Not established (safety/efficacy); should not be used.
Older Adults Require a mandatory dose reduction (e.g., 50%) due to accumulation risk.
Renal Impairment Requires an official dose reduction.
Pregnancy and Lactation Safety is not established. Breastfeeding must be stopped if used.

Use is further restricted by the regulatory requirement that it may only be initiated if other standard analgesics are contraindicated for the patient.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Katadolon (Flupirtine maleate) interaction information is based strictly on regulatory documents, focusing on combinations that require restriction or mandatory patient monitoring.


Documented Interaction Restrictions

Category Interaction Rule (Official Statement)
Hepatotoxic Drugs Formally contraindicated for co-administration with other medicinal products known to cause drug-induced liver injury (DILI).
Oral Anticoagulants Co-administration may potentiate anticoagulant effects (e.g., Warfarin), requiring mandatory and regular monitoring of blood coagulation times (Prothrombin Time/PT).
Paracetamol (Acetaminophen) Concurrent use increases the potential for hepatotoxicity.
CNS Depressants Co-administration with alcohol and sedatives (e.g., Benzodiazepines) results in the potentiation of central nervous system effects, specifically tiredness and dizziness.
Enzyme Inducers Co-administration with Carbamazepine is not advisable.

Population-Specific Interaction Notes

Interaction risk is heightened in specific populations. Katadolon is contraindicated in patients with pre-existing liver disease, cholestasis, or hepatic encephalopathy. Caution is also advised for use in individuals who are chronic alcohol users, due to the increased risk of serious liver injuries.


Administration Context

No mandatory time-separation windows are documented that require the drug to be spaced by a specific number of hours from other medicines. Flupirtine maleate can be administered with or without food.

Mechanism of Action

Selective Activation of Kv7 Potassium Channels (SNEPCO)

The core action of Flupirtine maleate is defined by its role as a Selective Neuronal Potassium Channel Opener ( SNEPCO). The molecule directly activates voltage-gated potassium channels—primarily the Kv7/ KCNQ isoforms—on central nervous system ( CNS) neurons. This interaction facilitates potassium ion ( K^+) efflux, causing the neuronal membrane to hyperpolarize. This hyperpolarization causes neuronal stabilization, which attenuates the generation of action potentials and reduces the transmission of signals within the nociceptive pathway.

Downstream Pathway Modulation and Independence

The resulting shift in membrane potential functionally limits the activity of excitatory systems, such as those mediated by Glutamate and N-methyl-D-aspartate ( NMDA) receptors. Furthermore, this hyperpolarization includes the depression of the spinal polysynaptic flexor reflex, a key mechanism associated with the physiological effect of depressed skeletal muscle tone. The molecule exerts these effects without binding to opioid receptors (mu, delta, kappa) or inhibiting cyclooxygenase ( COX) enzymes, confirming its mediation by distinct ion channel and reflex pathways.

Dosage and Administration Information

How to Use Katadolon: Official Administration Guidelines

Katadolon (Flupirtine maleate) is indicated for use via the oral, rectal, and intramuscular (i.m.) routes of administration. The medicine is available as 100 mg immediate-release (IR) capsules, 400 mg modified-release (MR) tablets, and suppositories. The standard usage involves the administration of the lowest effective dose for the shortest duration necessary.

The standard adult regimen for the IR capsule is 100 mg taken three to four times per day, with the daily intake limited to a maximum of 600 mg. The MR tablet is dosed at 400 mg once daily and is typically taken after meals with water. Both capsules and tablets must be swallowed whole and should not be crushed or chewed. For the oral and rectal forms, the duration of treatment must not exceed 2 weeks. Furthermore, the medicine is used when standard analgesics are deemed unsuitable or contraindicated.

Dosage adjustments are required for specific populations. The initial dose is reduced by 50% for older adults and for patients with renal or hepatic impairment. Flupirtine maleate is not recommended for use in pediatric patients under 18 years of age due to insufficient data on its safety and efficacy.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview

This section outlines the research that has explored patient-reported outcomes associated with the studied compound (Flupirtine), primarily for people with chronic pain. The compound's pharmacological classification is as a selective neuronal potassium channel opener (SNEPCO).

Clinical Evaluation

Research has evaluated this compound as a treatment for various pain states, including musculoskeletal pain and neuropathic conditions. Studies of this compound typically included adult patients. Early clinical data and open-label case series explored its use as an adjunct to opioids for the management of neuropathic pain, examining effects on pain scores and quality of life measures.

Key Study Findings

Phase 3 trials examined the compound’s effect on the severity of pain, typically over short-term durations (e.g., 12 weeks). Primary endpoints commonly included changes in standardized pain scales, such as the Visual Analog Scale (VAS) pain score, compared to placebo or other evaluated treatments.

Study Focus Key Metric Evaluated
Neuropathic Pain Changes in neuropathic pain discriminant scores
Musculoskeletal Pain VAS and Numerical Rating Scale (NRS) scores compared to NSAIDs

Pharmacokinetic studies examined how the compound is absorbed, distributed, metabolized, and excreted. These studies established the pharmacokinetic profile used in the clinical trials.

Limitations of Current Evidence

Evidence remains limited regarding long-term outcomes beyond the typical 12-week trial duration. Additionally, uncertainty remains regarding whether the observed effects are transferable to all forms of chronic pain beyond the specific conditions studied.

Frequently Asked Questions (FAQ)

Common questions about Katadolon (FAQ)

Q: Is Katadolon the same kind of pain relief as Tylenol or ibuprofen?

A: No, official product information indicates Katadolon is a different type of analgesic. It is classified as a centrally acting medicine that operates by opening specific neuronal potassium channels (SNEPCO). This mechanism is pharmacologically distinct from that of non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and is also different from the action of Tylenol (Acetaminophen).

Q: Can Katadolon be taken for tension headaches?

A: Official therapeutic indications for Katadolon are restricted to the treatment of acute pain in adults. Earlier evidence did suggest a use for pain associated with muscle tension, which relates to its known secondary muscle-relaxant effect. However, the approved use is not specifically indicated for tension headaches.

Q: Are there any foods or drinks I need to avoid while taking Katadolon?

A: Official documents state that co-administration with alcohol is strongly restricted because it may increase central nervous system effects, such as tiredness and dizziness. The medicine can otherwise be administered with or without food.

Q: Is Katadolon used for muscle spasms or just pain?

A: Katadolon is primarily classified as an analgesic (pain reliever). Its specific mechanism of action in the central nervous system can ease skeletal muscle tension, which is why it is considered to have secondary muscle-relaxant properties. The primary approved use is the management of pain.

Q: Is Katadolon considered addictive or habit-forming?

A: Katadolon is classified as a non-opioid, non-narcotic analgesic. Research examining its potential for abuse found that, at therapeutic doses, it did not show characteristics that would classify it as highly addictive or habit-forming.

Q: Is it okay to drive a car while taking Katadolon?

A: Official safety documents caution that the medicine may impair the ability to drive or operate heavy machinery. This regulatory warning is based on the listing of common adverse reactions, such as dizziness and drowsiness.

Q: How long does the effect of one Katadolon pill typically last?

A: The duration of the analgesic effect is reflected by the recommended dosing schedule. The immediate-release (IR) capsule is typically dosed three to four times daily, while the modified-release (MR) tablet is designed for once-daily administration.

Q: Does taking Katadolon with food change how it works?

A: According to official administration information, the medicine can generally be taken with or without food. For the modified-release tablet, however, patients are typically advised to take it after a meal.

Q: What are the most common reasons a doctor might prescribe Katadolon?

A: Official prescribing guidelines restrict the medicine's use to treating acute pain in adults. It is reserved for use when patients are unable to use other standard pain relievers, such as NSAIDs or weak opioids, because those treatments are contraindicated.

Q: What kind of pain is Katadolon best suited to treat?

A: Research has evaluated this compound for various pain states, including musculoskeletal pain and certain neuropathic conditions. However, regulatory agencies restrict its official use to the management of acute pain only when alternative treatments are unsuitable.

Q: Does Katadolon affect sleep patterns?

A: Official product information lists drowsiness as a common adverse reaction of the medicine. This central nervous system effect may consequently influence a patient’s overall sleep-wake cycle or timing.

Q: What is the research evidence for using Katadolon for chronic back pain?

A: Research has evaluated the compound’s effectiveness in treating different types of musculoskeletal pain, including in studies for lower back pain. However, official documents emphasize that evidence is limited for long-term use, consistent with the mandatory two-week maximum duration of treatment.

Q: What are the guidelines for discontinuing Katadolon use?

A: Regulatory documents state that treatment duration is strictly limited and must not exceed two weeks due to the risk of liver injury. Use is required to be discontinued after this mandatory period. Specific clinical tapering instructions are generally considered a clinical decision and are not detailed in public regulatory FAQs.

Q: How does the time of day I take Katadolon matter?

A: The time of day matters primarily for maintaining the correct dosing interval for the prescribed formulation. Given that the medicine can cause a common side effect of drowsiness, the timing of administration may align with the safety profile, such as taking it before bed.

Q: Does Katadolon cause problems with concentration?

A: Common adverse reactions involve the central nervous system, specifically dizziness and drowsiness. These effects may consequently impact a person’s attention and concentration during use.

Q: Can Katadolon be taken with cold and flu medicine?

A: Official interaction documents note that many common cold and flu medicines contain Paracetamol (Acetaminophen). Co-administration with Paracetamol is formally restricted due to the increased risk of liver toxicity. Caution is required to avoid co-administration with any other hepatotoxic substances.

Q: How quickly can I expect Katadolon to start working?

A: The medicine is generally absorbed rapidly into the body. For the immediate-release form, official pharmacokinetic data indicates that the time needed to reach its peak level in the blood is typically less than one hour after administration.

Q: What should I do if I forget to take a dose of Katadolon?

A: Regulatory instructions typically state that if a dose is missed, the next dose should be taken at the regularly scheduled time. Patients are advised that a double dose should not be taken to compensate for the forgotten capsule or tablet.

Q: What happens if I take Katadolon past its expiration date?

A: Regulatory authorities describe that the full potency and safety of a medicine cannot be guaranteed after its expiration date. The official requirement is that expired or unused medicine must be disposed of using proper pharmacy take-back schemes.

Q: Does Katadolon interact with antidepressant medications?

A: The official interaction list does not specifically contraindicate all antidepressants. However, co-administration with any medicines that are central nervous system (CNS) depressants may potentially potentiate effects like tiredness and dizziness.

Q: What is the risk of overdose with Katadolon?

A: Overdose can occur with this medicine. Regulatory documents state that in cases of overdose, known symptoms are typically the intensified side effects of the medicine, such as pronounced sleepiness and other pronounced central nervous system effects.

Q: Has Katadolon been recalled for any safety issues?

A: Yes. Due to the continued risk of serious liver injury (hepatotoxicity), regulatory bodies in the European Union recommended the withdrawal of the marketing authorization for flupirtine-containing medicines in 2018.

Q: Does Katadolon have a withdrawal effect if stopped suddenly?

A: The medicine is centrally acting, and its use is limited to a maximum of two weeks. Regulatory documents do not list specific withdrawal syndrome symptoms as a common adverse reaction associated with stopping use.

How should Katadolon be stored and disposed of?

How to Store and Dispose of Katadolon?

The storage and disposal of Katadolon (Flupirtine maleate) must strictly follow official regulatory requirements to maintain product stability and ensure public safety.


Storage Requirements

Katadolon capsules must be stored at room temperature, typically below 25 C or 30 C. The medicine must be kept in its original container and protected from light and moisture. A mandatory safety requirement is to keep the product out of the sight and reach of children.


Disposal Instructions

Unused or expired Katadolon must be disposed of in accordance with local regulations, often through a pharmacy take-back scheme. It is strictly prohibited to dispose of the medicine by pouring it down the wastewater system (toilet or sink) or by throwing it into household trash.

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

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