Katadolon: Effects, Dosage and Side Effects
Katadolon is a prescription pain medication containing the active ingredient flupirtine, used for moderate to severe pain conditions.
Things worth knowing about "Katadolon"
Katadolon is a prescription pain medication containing the active ingredient flupirtine, used for moderate to severe pain conditions.
What is Katadolon?
Katadolon is a prescription medication containing the active ingredient flupirtine. It belongs to the class of centrally acting, non-opioid analgesics (pain relievers) and was used to treat moderate to severe pain. Katadolon was available in several dosage forms, including capsules and modified-release tablets (Katadolon S long), which provide a prolonged release of the active ingredient over time.
Active Ingredient and Mechanism of Action
The active ingredient flupirtine acts as a Selective Neuronal Potassium Channel Opener (SNEPCO). By opening these potassium channels, nerve cells become hyperpolarized, meaning they are less excitable and less likely to transmit pain signals through the central nervous system.
In addition, flupirtine acts as an indirect NMDA receptor antagonist, inhibiting the overactivation of certain pain receptors. This dual mechanism distinguishes Katadolon from classical pain medications such as NSAIDs (non-steroidal anti-inflammatory drugs) or opioids.
Flupirtine also exhibits a muscle-relaxant component, which was particularly beneficial for pain accompanied by muscle tension or spasms.
Indications
Katadolon was primarily indicated for:
- Acute and chronic musculoskeletal pain (e.g., back pain, muscle tension)
- Post-operative or post-traumatic pain
- Tension-type headaches
- Neuropathic pain conditions
Dosage and Usage Notes
The dosage of Katadolon was determined based on pain severity and the individual response of the patient. The standard dose for adults was 100 mg flupirtine (one capsule) up to three times daily. The modified-release formulation Katadolon S long was typically taken as 400 mg once daily. The maximum daily dose was 600 mg. Katadolon was not intended for use beyond two weeks without medical supervision.
Side Effects
Like all medications, Katadolon can cause side effects. Common side effects include:
- Fatigue and dizziness
- Nausea and vomiting
- Stomach discomfort
- Dry mouth
- Sleep disturbances
- Elevated liver enzymes (transaminases)
A particularly important and serious side effect is hepatotoxicity (liver toxicity). Due to reports of severe liver dysfunction and liver failure associated with flupirtine use, the European Medicines Agency (EMA) significantly restricted the use of Katadolon in 2013.
Contraindications and Important Warnings
Katadolon must not be used in patients with:
- Known hypersensitivity to flupirtine or any excipient
- Pre-existing liver disease
- Alcohol dependency or regular alcohol consumption
- Myasthenia gravis (a neuromuscular disorder)
- Pregnancy or breastfeeding
- Children and adolescents under 18 years of age
Patients taking Katadolon were advised to have their liver function monitored regularly during treatment.
Regulatory Status and Current Availability
Due to the increased risk of serious liver damage, the European Medicines Agency (EMA) restricted flupirtine-containing medicines to a maximum treatment duration of two weeks in 2013 and significantly narrowed their approved indications. In Germany, the marketing authorization for Katadolon and other flupirtine-containing products was fully withdrawn in 2018. As a result, Katadolon is no longer commercially available in Germany.
References
- European Medicines Agency (EMA): Assessment report on flupirtine-containing medicines (2013). Available at: www.ema.europa.eu
- Federal Institute for Drugs and Medical Devices (BfArM): Notice on the withdrawal of marketing authorization for flupirtine (2018). Available at: www.bfarm.de
- Drug Commission of the German Medical Association (AkdAe): Dear Doctor Letter on flupirtine – risk of severe liver damage (2013). Available at: www.akdae.de
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