Europe — EMA
Mydeton (Tolperisone Hydrochloride)
GNH USA supplies Mydeton (Tolperisone Hydrochloride), a centrally acting skeletal muscle relaxant for muscle spasm, musculoskeletal pain, and skeletal muscle
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What is Tolperisone Hydrochloride?
Tolperisone Hydrochloride, the active ingredient in Mydeton, is a centrally acting skeletal muscle relaxant presented as an oral tablet for oral use. It is indicated for the relief of muscle spasm, musculoskeletal pain, and other skeletal muscle disorders in adult patients.
GNH USA supplies Mydeton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Tolperisone Hydrochloride used for?
Mydeton (tolperisone hydrochloride) acts on central spinal and brain‑stem pathways to reduce abnormal muscle tone and is used for several musculoskeletal conditions.
- Muscle spasm: reduces involuntary contractions and associated discomfort. - Musculoskeletal pain: alleviates pain related to muscle strain, overuse or injury. - Skeletal muscle disorders: improves muscle tone and functional mobility. - Spasticity in neurological conditions: helps relax hypertonic muscles and facilitates movement.
What are the side effects of Tolperisone Hydrochloride?
Tolperisone hydrochloride is generally well tolerated, but a range of adverse reactions have been reported.
Common Side Effects: - Dizziness: sensation of light‑headedness or unsteadiness. - Drowsiness: mild sedation or fatigue. - Nausea: upset stomach often with transient vomiting. - Dry mouth: reduced salivation causing throat discomfort. - Headache: mild to moderate cranial pain. - Gastro‑intestinal upset: abdominal discomfort or dyspepsia.
Serious or Rare Side Effects: - Hypotension: marked drop in blood pressure, potentially causing faintness. - Severe allergic reaction (anaphylaxis): rash, swelling, breathing difficulty. - Liver enzyme elevation: signs of hepatic stress requiring monitoring. - Blood dyscrasias: rare cases of leukopenia or thrombocytopenia. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
What precautions apply to Tolperisone Hydrochloride?
When prescribing Mydeton, clinicians should consider several safety aspects.
- Renal impairment: monitor renal function and adjust use as needed. - Hepatic dysfunction: use with caution and observe liver enzymes regularly. - Elderly patients: increased sensitivity to central nervous system effects; start with lower doses. - Concomitant CNS depressants: may enhance sedation or dizziness. - Pregnancy and lactation: safety not established; avoid unless benefit outweighs risk. - Store at room temperature: keep in the original pack, protect from moisture and light.
What does Tolperisone Hydrochloride interact with?
Tolperisone hydrochloride may interact with other medicines, requiring attention to avoid adverse outcomes.
Major Interactions (Avoid): - Other muscle relaxants: risk of excessive central nervous system depression. - Antihypertensive agents: may potentiate hypotensive effects. - Monoamine oxidase inhibitors (MAOIs): increased risk of central nervous system adverse events.
Moderate Interactions (Monitor Closely): - CYP450 substrate drugs: tolperisone may alter their metabolism. - Alcohol: can enhance drowsiness and dizziness. - Anticholinergic medications: may increase dry‑mouth sensation. - Sedative antihistamines: potential additive sedation.



