Europe — EMA
Mydoflex (Tolperisone Hydrochloride)
GNH USA supplies Mydoflex (Tolperisone Hydrochloride), a muscle relaxant for muscle spasm, low back pain and spasticity. Request a quote for global supply.
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What is Tolperisone Hydrochloride?
Tolperisone Hydrochloride, the active ingredient in Mydoflex, is a muscle relaxant presented as an oral formulation for oral use. It is employed to alleviate muscle spasm and related musculoskeletal discomfort in adult patients. GNH USA supplies Mydoflex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Tolperisone Hydrochloride used for?
Tolperisone Hydrochloride is indicated for conditions involving abnormal muscle tone and pain. - Muscle spasm: reduces involuntary muscle contractions and associated discomfort. - Low back pain: eases tension in lumbar musculature, improving mobility. - Cervical pain: diminishes neck muscle stiffness and pain. - Musculoskeletal pain: alleviates generalized skeletal muscle discomfort. - Spasticity: lowers hypertonic muscle activity in neurological disorders.
What are the side effects of Tolperisone Hydrochloride?
Adverse reactions may occur with any muscle‑relaxant therapy.
Common Side Effects: - Dizziness: transient sensation of light‑headedness. - Nausea: mild to moderate stomach upset. - Headache: occasional tension‑type headache. - Dry mouth: reduced salivation.
Serious or Rare Side Effects: - Severe skin reactions: such as Stevens‑Johnson syndrome. - Liver enzyme elevation: indicating possible hepatic stress. - Blood dyscrasias: including agranulocytosis or leukopenia.
What precautions apply to Tolperisone Hydrochloride?
Careful assessment is recommended before initiating therapy. - Renal impairment: adjust use if renal function is reduced. - Hepatic impairment: monitor liver function during treatment. - Elderly patients: start with lower doses due to increased sensitivity. - Concomitant CNS depressants: avoid additive sedation. - Pregnancy: safety not established; weigh benefits against risks. - Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture.
What does Tolperisone Hydrochloride interact with?
Potential drug‑drug interactions should be reviewed prior to prescribing.
Major Interactions (Avoid): - Other central muscle relaxants: risk of excessive CNS depression. - MAO inhibitors: may cause pronounced hypotension.
Moderate Interactions (Monitor Closely): - Antihypertensives: possible additive blood‑pressure lowering effect. - Anticoagulants: monitor for increased bleeding tendency. - CYP450 inhibitors: may raise tolperisone plasma levels, requiring observation.



