Product image of Mydocalm (Tolperisone Hydrochloride) supplied by GNH India

Mydocalm

Active Ingredient:
Tolperisone Hydrochloride
Origin:
EU

Mydocalm (Tolperisone Hydrochloride)

Tolperisone hydrochloride, the active ingredient in Mydocalm, is a centrally acting skeletal muscle relaxant presented as an oral tablet for oral use. It is employed to reduce muscle tone and alleviate spasticity in patients with muscle‑related disorders.

GNH India supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality assurance, regulatory compliance, and reliable logistics for global distribution. With a focus on consistent product integrity, GNH India supports healthcare providers in delivering effective muscle‑relaxant therapy across diverse markets.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Mydocalm (tolperisone hydrochloride) acts on the central nervous system to reduce abnormal muscle tone in several conditions.

  • Muscle spasm: alleviates involuntary muscle contractions and associated discomfort.
  • Skeletal muscle pain: reduces pain related to muscle strain or overuse.
  • Spasticity associated with neurological disorders: diminishes heightened muscle tone in conditions such as multiple sclerosis or post‑stroke syndrome.

How It Works

  • Tolperisone hydrochloride exerts its effect by blocking voltage‑gated sodium and calcium channels in spinal cord and supraspinal neurons. This inhibition decreases the influx of excitatory ions, leading to reduced neuronal firing and lowered alpha‑motor neuron activity. The resulting decline in peripheral muscle fiber excitation produces a relaxation of skeletal muscles without significant sedation. Because the drug acts centrally, it does not directly affect the contractile apparatus of the muscle.

Side Effects

Tolperisone hydrochloride may be associated with a range of adverse reactions, varying from mild and transient to serious and potentially life‑threatening.

Common Side Effects

  • Dizziness: a feeling of light‑headedness or unsteadiness that may affect balance.
  • Nausea: mild to moderate stomach upset, sometimes accompanied by a urge to vomit.
  • Headache: transient cranial discomfort ranging from mild pressure to throbbing pain.

Serious or Rare Side Effects

  • Hypotension: a marked reduction in blood pressure that can cause fainting or dizziness.
  • Hepatotoxicity: signs of liver injury such as jaundice, elevated liver enzymes, or abdominal pain.
  • Anaphylaxis: an acute allergic reaction presenting with breathing difficulty, swelling, hives, and possible shock.

Precautions & Warnings

When prescribing Mydocalm, clinicians should consider several precautionary measures to ensure patient safety.

  • Renal impairment: assess kidney function and adjust therapy if necessary.
  • Hepatic impairment: monitor liver enzymes and use with caution in liver disease.
  • Elderly patients: start with lower doses and observe for increased sensitivity.
  • Concomitant CNS depressants: evaluate risk of additive sedation or dizziness.
  • Pregnancy and lactation: safety not established; avoid use unless benefits outweigh risks.
  • Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mydocalm may interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Other centrally acting muscle relaxants: combined effect may cause excessive muscle weakness.
  • Monoamine oxidase inhibitors (MAOIs): risk of severe hypotension or serotonin syndrome.
  • Strong CYP450 inhibitors: may increase tolperisone plasma levels.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: additive blood pressure‑lowering effect.
  • Antidiabetic medications: possible alteration of glucose control.
  • Alcohol: may enhance central nervous system depression.

Frequently Asked Questions

Mydocalm contains tolperisone hydrochloride, a centrally acting skeletal muscle relaxant indicated for relief of muscle spasm, reduction of skeletal muscle pain, and management of spasticity associated with neurological disorders such as multiple sclerosis or post‑stroke syndrome.

Tolperisone hydrochloride blocks voltage‑gated sodium and calcium channels in spinal and supraspinal neurons, decreasing excitatory ion influx. This reduces neuronal firing and alpha‑motor neuron activity, leading to lower peripheral muscle fiber excitation and resulting in muscle relaxation without significant sedation.

The dosage of Mydocalm is individualized by the prescribing healthcare professional based on the patient’s condition, age, renal and hepatic function, and response to therapy. The prescriber determines the appropriate strength, frequency, and duration of treatment.

Safety data for tolperisone hydrochloride in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and a healthcare provider should be consulted.

To request Mydocalm, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with other centrally acting muscle relaxants such as baclofen or tizanidine, tolperisone has a lower incidence of sedation and does not act directly on GABA receptors. Its mechanism focuses on sodium and calcium channel blockade, offering muscle relaxation with a different side‑effect profile.

Mydocalm should be stored at ambient temperature, preferably below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and strong odors to maintain its stability and potency throughout its shelf life.

Mydocalm is supplied as an oral tablet and is taken by mouth with or without food, as directed by the prescribing clinician. Swallow the tablet whole with a glass of water; do not crush or chew unless specifically instructed.

The most serious adverse reactions reported with tolperisone include severe hypotension, hepatotoxicity manifested by jaundice or elevated liver enzymes, and anaphylactic reactions that can cause breathing difficulty, swelling, and shock. Immediate medical attention is required if any of these symptoms occur.

Mydocalm is contraindicated in patients with known hypersensitivity to tolperisone or any excipients, and it should be avoided in individuals taking MAO inhibitors. Caution is also advised for patients with uncontrolled cardiovascular disease, severe liver impairment, or those who are pregnant without a clear therapeutic justification.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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