Tolmio
Tolmio: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Tolmio
ATX code: М03ВХ04
Active ingredient: tolperisone (Tolperisone) + lidocaine (Lidocaine)
Manufacturer: JSC "BINNOPHARM" (Russia)
Description and photo updated: 2020-13-02
Tolmio is a combined centrally acting muscle relaxant.
Release form and composition
The drug is produced in the form of a solution for intravenous (i / v) and intramuscular (i / m) administration: a transparent, colorless or pale greenish-yellow liquid with a characteristic odor, without mechanical impurities [1 ml each in an ampoule of light-protective neutral glass with a colored dot and a notch, or with a colored break ring (there may be from 1 to 3 rings); in a contour acheikova packing of 5 ampoules, in a cardboard box 1 or 2 packages and instructions for use of Tolmio].
1 ml of solution contains:
- active substances: lidocaine hydrochloride (in terms of anhydrous substance) - 2.5 mg; tolperisone hydrochloride - 100 mg;
- additional components: diethylene glycol monoethyl ether, methyl parahydroxybenzoate, water for injection, hydrochloric acid solution 1M.
Pharmacological properties
Pharmacodynamics
Tolmio is a combined preparation, the effect of which is due to the properties of its active ingredients.
Tolperisone hydrochloride belongs to the central muscle relaxants. The exact mechanism of its action has not been established. Due to the membrane-stabilizing effect of this substance, it is not allowed to conduct excitation in motor neurons and primary afferent fibers by inhibiting mono- and polysynaptic reflexes of the spinal cord. The secondary mechanism of action of tolperisone is supposedly to suppress the release of the transmitter by blocking the entry of calcium ions into the synapses. In the reticulospinal tract of the brain stem, the active substance causes a decrease in reflex readiness. Tolperisone increases peripheral blood flow, which is not due to the effect on the central nervous system (CNS) and may be due to its weak antiadrenergic and antispasmodic effect.
Lidocaine hydrochloride demonstrates a local anesthetic effect and, when used in doses corresponding to those recommended in the instructions, does not exhibit a systemic effect.
Pharmacokinetics
Tolperisone hydrochloride undergoes intensive biotransformation in the liver and kidneys to metabolites, the pharmacological activity of which has not been established. The latter are excreted in the urine almost completely, more than 99% of the dose taken. The half-life (T 1/2) after intravenous administration is approximately 1.5 hours.
Lidocaine hydrochloride is completely absorbed, and the rate of absorption is influenced by the site of administration and the dose. The period of reaching the maximum concentration (C max) in blood plasma with intramuscular injection is 30–45 minutes. The substance can bind to plasma proteins by 50–80% and is characterized by rapid distribution in tissues and organs. Passes through the placenta and the blood-brain barrier (BBB), excreted in breast milk (40% of the content in the mother's plasma). It is metabolized by 90–95% in the liver with the participation of microsomal enzymes through dealkylation of the amino group and rupture of the amide bond with the formation of active metabolites. It is eliminated by the kidneys (up to 10% in unchanged form), as well as with bile, while part of the administered dose is reabsorbed in the gastrointestinal tract (GIT).
Indications for use
- spasticity due to stroke (symptomatic treatment);
- painful muscle spasm associated with such diseases of the musculoskeletal system as spondyloarthrosis, spondylosis, lumbar and cervical syndromes (therapy).
Contraindications
Absolute:
- severe myasthenia gravis;
- age up to 18 years;
- pregnancy, lactation period;
- hypersensitivity to any component of the product.
It is recommended to use Tolmio with caution in patients with renal and / or hepatic insufficiency.
Tolmio, instructions for use: method and dosage
Tolmio's injections are administered intramuscularly or intravenously.
The drug is used daily, a single dose is 1 ml of solution. IM Tolmio is recommended to be administered 2 times a day, IV - 1 time per day.
Side effects
- immune system: rarely - anaphylactic reactions, hypersensitivity reactions; extremely rare - anaphylactic shock;
- nervous system: infrequently - dizziness, drowsiness, headache; rarely - lethargy, attention deficit disorder, loss / disorder of sensitivity, tremors, seizures;
- blood and lymphatic system: extremely rare - lymphadenopathy, anemia;
- mental disorders: infrequently - sleep disorder, insomnia; rarely - loss of activity, depression;
- metabolism and nutrition: infrequently - anorexia; extremely rare - polydipsia;
- organ of hearing and labyrinthine disorders: rarely - ringing in the ears, vertigo;
- organ of vision: rarely - visual impairment;
- cardiovascular system: infrequently - arterial hypotension; rarely - hot flushes, heart palpitations, tachycardia, angina pectoris; extremely rare - bradycardia;
- respiratory system, chest and mediastinal organs: rarely - rapid breathing, epistaxis, shortness of breath;
- hepatobiliary system: rarely - liver dysfunction;
- Gastrointestinal tract: infrequently - dry mouth, gastrointestinal discomfort, dyspepsia, diarrhea, nausea; rarely - flatulence, epigastric pain, vomiting, constipation;
- kidneys and urinary tract: rarely - proteinuria, enuresis;
- musculoskeletal and connective tissue: infrequently - muscle weakness, pain in the limbs, myalgia; rarely - discomfort in the limbs; extremely rare - osteopenia;
- skin and subcutaneous tissues: rarely - sweating, skin rash, pruritus, urticaria, allergic dermatitis;
- general disorders and disorders at the injection site: often - redness of the skin at the injection site; infrequently - fatigue, weakness, malaise; rarely - irritability, thirst, feeling of heat, feeling of intoxication; extremely rare - a feeling of discomfort in the chest;
- instrumental and laboratory data: rarely - a decrease in blood pressure (BP), an increase in bilirubin levels, impaired liver function tests, an increase in the number of leukocytes, a decrease in the number of platelets; extremely rare - an increase in creatinine content.
Overdose
The main symptoms of a Tolmio overdose include dyspnea, tonic / clonic seizures, ataxia, and respiratory arrest.
The specific antidote is unknown. If necessary, symptomatic and supportive treatment is prescribed.
special instructions
The optimal dosage regimen of the drug is established by the attending physician.
Influence on the ability to drive vehicles and complex mechanisms
During the period of Tolmio therapy, patients who drive vehicles or other complex and potentially dangerous equipment need to be careful.
Application during pregnancy and lactation
During pregnancy and lactation, drug therapy is contraindicated due to the lack of information about the safety and efficacy of the drug in pregnant and lactating women.
Pediatric use
Tolmio is not assigned to persons under the age of 18.
With impaired renal function
Patients with renal impairment should use Tolmio under medical supervision. There is no need to change the dosage regimen.
For violations of liver function
Patients with hepatic impairment should use the drug under medical supervision. It is not required to adjust the dosage regimen in such cases.
Drug interactions
There is no data on the interaction of Tolmio with drugs other than those listed below, limiting its use:
- sedatives, hypnotics and ethanol-containing drugs: combined use with these drugs is allowed, because despite the effect of tolperisone on the central nervous system, Tolmio does not have a sedative effect;
- non-steroidal anti-inflammatory drugs (NSAIDs): Tolmio enhances their pharmacological efficacy, which may require a reduction in the dose of drugs in this group;
- ethanol: there was no increase in its effect on the central nervous system when used simultaneously with Tolmio.
Analogs
Tolmio's analogues are Baklosan, Kalmirex, Sirdalud, Tolizor Inject, Tolperisone + Lidocaine, Lidamitol, Midocalm-Richter, etc.
Terms and conditions of storage
Store in a place out of the reach of children, protected from light, at a temperature of 8-15 ° C.
The shelf life is 1.5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tolmio
The few reviews about Tolmio left by patients on specialized sites are mostly positive. The drug is considered an effective remedy that relieves painful muscle spasm with lesions of the musculoskeletal system. The advantages of the tool include its relatively low cost.
Sometimes there are complaints about the development of unwanted side effects after the administration of Tolmio injections.
Price for Tolmio in pharmacies
The price of Tolmio in the form of a solution for intravenous and intramuscular administration of 1 ml in an ampoule can be: for 5 ampoules in a package - 320–360 rubles; for 10 ampoules in a package - 560–690 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
