Myolax Plus1 ml

Myolax Plus is an injectable combination of a centrally-acting skeletal muscle relaxant (tolperisone) with a small amount of local anesthetic (lidocaine) added mainly to reduce pain at the injection site.

Established use

• Symptomatic relief of painful reflex muscle spasm and pathologically increased muscle tone (hypertonia) associated with musculoskeletal disorders, such as acute low back pain, cervical/lumbar spondylosis, and painful muscular stiffness (e.g., torticollis).

Guideline-supported / adjunct use

• Adjunct symptomatic treatment of spasticity resulting from central nervous system lesions (e.g., post-stroke spasticity, spinal cord disease), used together with physiotherapy and rehabilitation rather than as sole therapy.

Myolax Plus treats the muscle spasm and associated pain; it is not a cure for the underlying musculoskeletal or neurological condition, and is generally intended for short-term use during an acute painful episode.

Each formulation of Tolperisone + Lidocaine is an injectable solution typically supplied as: Tolperisone Hydrochloride 100 mg and Lidocaine Hydrochloride 2.5 mg per 1 mL ampoule, for deep intramuscular (IM) injection. The lidocaine component is present at a low, local (non-systemic-anesthetic) dose solely to reduce discomfort during intramuscular injection of tolperisone.

Myolax Plus is a fixed combination injectable product used for the short-term relief of painful muscle spasm and increased muscle tone. Tolperisone is a centrally-acting muscle relaxant that reduces excessive, pathological muscle tone without generally causing significant sedation at therapeutic doses. Lidocaine, an amide-type local anesthetic, is included in the injectable formulation at a low dose to numb the injection site and minimize injection-associated pain; it is not intended to provide systemic anesthesia or analgesia.

Myolax Plus is administered only by deep intramuscular injection, under medical supervision, and is generally used for a limited course during an acute episode of painful muscle spasm.

Myolax Plus belongs to the therapeutic class of centrally-acting skeletal muscle relaxants (tolperisone component), combined with a low-dose amide-type local anesthetic (lidocaine component) used as an injection-site pain reducer rather than as an independent therapeutic agent.

Tolperisone acts primarily on the central nervous system. It has a membrane-stabilizing, local-anesthetic-like action on nerve membranes and is thought to reduce pathologically increased muscle tone by inhibiting excitatory reflex pathways at the level of the spinal cord and reticular formation, with additional weak antispasmodic and mild central analgesic properties. Unlike some other muscle relaxants, it does not typically cause marked sedation at usual therapeutic doses.

Lidocaine, present in the injectable formulation of Tolperisone + Lidocaine, is an amide-type local anesthetic that blocks voltage-gated sodium channels in peripheral nerve endings at the injection site, reducing the pain of intramuscular injection. At the low dose included in this product, it is not intended to produce systemic anesthetic or antiarrhythmic effects.

Myolax Plus is for deep intramuscular (IM) injection only. It must not be given intravenously or subcutaneously. Injection should be performed by a trained healthcare professional using aseptic technique, rotating injection sites for repeated doses. Do not use the ampoule if the solution is discolored or contains particulate matter.

• CNS depressants (e.g., sedatives, hypnotics, other muscle relaxants, alcohol): Concomitant use with Myolax Plus may cause additive central nervous system depression (increased drowsiness/dizziness); use together with caution.
• Other local anesthetics or Class I antiarrhythmic drugs (e.g., mexiletine): Because Myolax Plus contains lidocaine, concurrent use with other agents that have local-anesthetic or membrane-stabilizing cardiac activity may increase the risk of additive cardiac and CNS toxicity.
• Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May reduce metabolism of the tolperisone component of Myolax Plus, potentially increasing its plasma levels and the risk of adverse effects; dose adjustment or closer monitoring may be needed.

• Common: Nausea, headache, generalized muscle weakness, drowsiness, dizziness, and mild hypotension.
• Injection-related: Pain, redness, or discomfort at the injection site.
• Uncommon/rare but serious: Hypersensitivity reactions ranging from skin rash and pruritus to, rarely, severe anaphylactic/anaphylactoid reactions (reported more frequently with the injectable tolperisone-containing formulations); seek immediate medical attention for signs of a severe allergic reaction such as facial/throat swelling, breathing difficulty, or sudden severe hypotension while using Myolax Plus.

Pregnancy: Human safety data for Myolax Plus in pregnancy are limited. It should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation: It is not established whether the components of Myolax Plus pass into breast milk. Use during breastfeeding only under medical advice, weighing benefit against potential risk to the infant.

• Hypersensitivity/anaphylaxis: Rare but serious hypersensitivity reactions, including anaphylaxis, have been reported with tolperisone-containing products, more frequently with injectable use; discontinue Myolax Plus immediately and seek emergency care if signs of a severe allergic reaction occur.
• Drowsiness/dizziness: Myolax Plus may cause drowsiness or dizziness in some patients; caution is advised when driving or operating machinery until individual response is known.
• Hypotension: Use with caution in patients prone to low blood pressure.
• Muscle weakness: Use cautiously in patients with pre-existing muscle weakness, and it is contraindicated in myasthenia gravis (see Contraindications).
• Route of administration: For deep intramuscular use only; inadvertent intravascular injection must be avoided.

Suspected overdose with Myolax Plus should be treated as a medical emergency. Seek immediate medical attention or contact a poison control center. Possible features of overdose may include marked drowsiness, muscle weakness, hypotension, and, due to the lidocaine component, CNS excitation or depression (e.g., dizziness, tinnitus, seizures) and cardiac conduction disturbances. Management is supportive and symptomatic, provided in a medical facility; there is no specific antidote.

Store at room temperature (below 30°C), protected from light. Do not freeze. Keep out of reach of children. Discard any unused portion of an opened ampoule.

• Pediatric patients: Safety and efficacy of the injectable form of Myolax Plus have not been established in children; its use is generally not recommended in this population.
• Elderly: Use with caution, starting at the lower end of the dosing range, as elderly patients may be more sensitive to hypotension, dizziness, and muscle weakness.
• Hepatic impairment: Use with caution and close monitoring, since tolperisone undergoes hepatic metabolism.
• Renal impairment: Use with caution, as elimination of tolperisone and its metabolites is renal; formal dose-adjustment data are limited.

Myolax Plus is generally used for a short course during an acute episode of painful muscle spasm, guided by clinical response, and then reassessed by the physician, often with a switch to oral therapy for any further treatment needed. It is not intended for indefinite long-term injectable use.

Tolperisone + Lidocaine combines a centrally-acting skeletal muscle relaxant (tolperisone) with an amide-type local anesthetic (lidocaine) used as an injection-site analgesic adjunct.

In Tolperisone + Lidocaine, tolperisone reduces pathologically increased muscle tone through a central, membrane-stabilizing action that dampens excessive excitatory reflex activity in the spinal cord and brainstem, without producing marked general sedation. Lidocaine, included at low dose, acts locally at the injection site by blocking sodium channels in peripheral nerve endings, reducing the pain of intramuscular injection.

The safety and efficacy of the injectable form of Myolax Plus have not been established in pediatric patients, and its use in children is generally not recommended. Any use in children should only be considered by a specialist physician when no suitable alternative exists, with close monitoring.