Tolizor
Tolisor caps 50 mg x30 Ozone INN: Tolperisone Release form: Hard gelatin capsules 50 mg No. 30 Ingredients: tolperisone hydrochloride 50 mg. Excipients: microcrystalline cellulose - 55.22 mg, lactose monohydrate (milk sugar) - 34.33 mg, croscarmellose sodium - 6.32 mg, hypromellose - 1.58 mg, citric acid monohydrate - 1.5 mg, magnesium stearate - 1.05 mg. the contents of the capsules are a mixture of powder and granules of white or almost white color with a characteristic odor; the contents of the capsules can be compacted into lumps in the shape of a capsule, which are easily destroyed when pressed. Composition of the capsule body: yellow iron oxide dye - 0.0733%, titanium dioxide - 1%, water - 14.5%, gelatin - up to 100%. Composition of the capsule cap: black iron oxide dye - 0.05%, titanium dioxide - 2%, water - 14.5%, gelatin - up to 100%. Pharmacotherapeutic group: Peripheral muscle relaxant
Indications
Spinal and cerebral palsy (hypertonicity, muscle spasms, spinal automatism, contracture of the limbs).
Diseases accompanied by dystonia, rigidity, muscle spasm, obliterating arterial diseases: obliterating atherosclerosis of the vessels of the extremities, diabetic angiopathy, thromboangiitis obliterans (Buerger's disease), Raynaud's syndrome.
Consequences of disorders of vascular innervation (acrocyanosis, intermittent angioedema).
Extrapyramidal disorders (postencephalitic and atherosclerotic parkinsonism).
Postthrombotic disorders of lymph circulation and venous circulation, trophic leg ulcer, spastic paralysis (Little's disease), epilepsy, encephalopathy of vascular origin, hypertonicity in combination with another type of muscle tone disorder.
ICD-10 codes
Dosage regimen
When taken orally, the initial dose is 50 mg 2-3 times/day, the dose is gradually increased to 150 mg 2-3 times/day. IM - 100 mg 2 times a day, IV - 100 mg/day once.
Side effect
Possible: headache, myasthenia gravis, arterial hypotension, nausea, vomiting, gastralgia, allergic reactions (anaphylactic shock, bronchospasm, urticaria, erythematous rashes, itching).
Contraindications for use
Myasthenia gravis, pregnancy, lactation, childhood and adolescence up to 18 years, increased sensitivity to tolperisone.
Use during pregnancy and breastfeeding
Contraindicated during pregnancy and lactation.
Use in children
Contraindicated in children under 1 year of age.
special instructions
Impact on the ability to drive vehicles and operate machinery
Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.
Drug interactions
The effect of tolperisone is enhanced by simultaneous use with drugs for general anesthesia, peripheral muscle relaxants, psychoactive drugs, and clonidine.
Tolisor caps 150 mg x30
Tolisor caps 150 mg x30 Ozone INN: Tolperisone Release Form: Hard gelatin capsules 150 mg No. 30 Composition: tolperisone hydrochloride 150 mg. Excipients: microcrystalline cellulose - 70 mg, lactose monohydrate (milk sugar) - 43.5 mg, croscarmellose sodium - 12 mg, hypromellose - 3 mg, citric acid monohydrate - 4.5 mg, magnesium stearate - 2 mg. The contents of the capsules are a mixture of powder and granules of white or almost white color with a characteristic odor; the contents of the capsules can be compacted into capsule-shaped lumps that are easily broken when pressed.
Composition of the capsule body: black iron oxide dye - 0.05%, titanium dioxide - 2%, water - 14.5%, gelatin - up to 100%. Composition of the capsule cap: black iron oxide dye - 0.75%, sunset yellow dye - 0.0059%, titanium dioxide - 2%, water - 14.5%, gelatin - up to 100%.
Pharmacotherapeutic group: Peripheral muscle relaxant
Indications
Spinal and cerebral palsy (hypertonicity, muscle spasms, spinal automatism, contracture of the limbs).
Diseases accompanied by dystonia, rigidity, muscle spasm, obliterating arterial diseases: obliterating atherosclerosis of the vessels of the extremities, diabetic angiopathy, thromboangiitis obliterans (Buerger's disease), Raynaud's syndrome.
Consequences of disorders of vascular innervation (acrocyanosis, intermittent angioedema).
Extrapyramidal disorders (postencephalitic and atherosclerotic parkinsonism).
Postthrombotic disorders of lymph circulation and venous circulation, trophic leg ulcer, spastic paralysis (Little's disease), epilepsy, encephalopathy of vascular origin, hypertonicity in combination with another type of muscle tone disorder.
ICD-10 codes
Dosage regimen
When taken orally, the initial dose is 50 mg 2-3 times/day, the dose is gradually increased to 150 mg 2-3 times/day. IM - 100 mg 2 times a day, IV - 100 mg/day once.
Side effect
Possible: headache, myasthenia gravis, arterial hypotension, nausea, vomiting, gastralgia, allergic reactions (anaphylactic shock, bronchospasm, urticaria, erythematous rashes, itching).
Contraindications for use
Myasthenia gravis, pregnancy, lactation, childhood and adolescence up to 18 years, increased sensitivity to tolperisone.
Use during pregnancy and breastfeeding
Contraindicated during pregnancy and lactation.
Use in children
Contraindicated in children under 1 year of age.
special instructions
Impact on the ability to drive vehicles and operate machinery
Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.
Drug interactions
The effect of tolperisone is enhanced by simultaneous use with drugs for general anesthesia, peripheral muscle relaxants, psychoactive drugs, and clonidine.
Tolisor, 150 mg, capsules, combi-pack 1+1, 30 pcs.
The safety profile of tolperisone drugs is confirmed by data from use in more than 12,000 patients. According to these data, the most frequently described disorders are skin and subcutaneous tissue disorders, general disorders, neurological disorders, and gastrointestinal disorders.
During the post-registration period, the number of reports received about the development of hypersensitivity reactions associated with the use of tolperisone was about 50–60% of all reports received. In most cases these were non-serious adverse reactions. Life-threatening allergic reactions have been reported very rarely.
The frequency of adverse reactions is classified according to the recommendations of the World Health Organization, characterized as: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rare (<1/10000), including isolated cases, frequency unknown (cannot be calculated based on available data).
From the blood and lymphatic system:
very rarely - anemia, lymphadenopathy.
From the immune system:
rarely - hypersensitivity reactions*, anaphylactic reactions; very rarely - anaphylactic shock.
Metabolism and nutrition:
infrequently - anorexia; very rarely - polydipsia.
From the mental side:
infrequently - sleep disturbance, insomnia; rarely - weakness, depression; very rarely - confusion.
From the nervous system:
infrequently - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, paresthesia, malaise, lethargy.
From the side of the organ of vision:
rarely - decreased visual acuity.
On the part of the hearing organ:
rarely - tinnitus, vertigo.
From the cardiovascular system:
infrequently - arterial hypotension; rarely - angina pectoris, tachycardia, palpitations, flushing of blood to the face; very rarely - bradycardia.
From the respiratory system:
rarely - shortness of breath, nosebleeds, tachypnea.
From the gastrointestinal tract:
uncommon - abdominal discomfort, dyspepsia, diarrhea, dry mouth, nausea; rarely - epigastric pain, constipation, flatulence, vomiting.
From the liver and biliary tract:
rarely - moderate liver failure.
For the skin and subcutaneous tissues:
rarely - allergic dermatitis, hyperhidrosis, itching, skin rash, urticaria.
From the musculoskeletal system and connective tissue:
uncommon - muscle pain, muscle weakness, pain in the extremities; rarely - discomfort in the limbs; very rarely - osteopenia.
From the kidneys and urinary tract:
rarely - enuresis, proteinuria.
General disorders and reactions at the injection site:
infrequently - asthenia, feeling of fatigue, malaise; rarely - a feeling of intoxication, a feeling of warmth, irritability, thirst; very rarely - chest discomfort.
Laboratory indicators:
rarely - hyperbilirubinemia, liver dysfunction, thrombocytopenia, leukocytosis; very rarely - hypercreatininemia.
*Angioedema, including swelling of the face and lips, has been reported during post-marketing monitoring (frequency unknown).
Tolisor® injection
Frequency of side effects: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from available data).
Blood and lymphatic system disorders:
very rarely - anemia, lymphadenopathy.
Immune system disorders:
rarely - hypersensitivity reactions, anaphylactic reactions; very rarely - anaphylactic shock.
Metabolic and nutritional disorders:
infrequently - anorexia; very rarely - polydipsia.
Mental disorders:
infrequently - insomnia, sleep disorders; rarely - loss of activity, depression.
Nervous system disorders:
infrequently - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, loss of sensitivity, sensory disorders, lethargy.
Visual disorders:
rarely - visual disturbances.
Hearing and labyrinth disorders:
rarely - ringing in the ears, vertigo.
Heart disorders
: rarely - angina pectoris, tachycardia, rapid heartbeat; very rarely - bradycardia.
Vascular disorders:
infrequently - arterial hypotension; rarely - “flushes” of blood.
Disorders of the respiratory system, chest and mediastinal organs:
rarely - shortness of breath, nosebleeds, rapid breathing.
Gastrointestinal disorders:
uncommon - gastrointestinal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely - epigastric pain, constipation, flatulence, vomiting.
Disorders of the liver and biliary tract:
rarely - liver dysfunction.
Disorders of the skin and subcutaneous tissues:
rarely - allergic dermatitis, sweating, itching, urticaria, skin rash.
Musculoskeletal and connective tissue disorders:
uncommon - muscle weakness, myalgia, pain in the extremities; rarely - discomfort in the limbs; very rarely - osteopenia.
Renal and urinary tract disorders
: rarely - enuresis, proteinuria.
General disorders and disorders at the injection site:
often - redness of the injection site; infrequently - asthenia (weakness), malaise, fatigue; rarely - a feeling of intoxication, a feeling of heat, irritability, thirst; very rarely - a feeling of discomfort in the chest.
Laboratory and instrumental data:
rarely - decreased blood pressure, increased bilirubin concentration, impaired liver function tests, decreased platelet count, increased leukocyte count; very rarely - increased creatinine levels.
Tolisor
The safety profile of tolperisone is confirmed by data from use in more than 12,000 patients. According to these data, the most common disorders were disorders of the skin and subcutaneous tissues, general disorders, disorders of the nervous system and gastrointestinal tract.
In the post-registration period, hypersensitivity reactions accounted for 50-60% of all adverse reactions. Most adverse reactions were not serious and resolved on their own.
Life-threatening hypersensitivity reactions have been reported very rarely.
Adverse reactions are listed below according to MedDRA classification and frequency: uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), frequency unknown ( cannot be estimated from the available data).
Blood and lymphatic system disorders:
very rarely - anemia, lymphadenopathy.
Immune system disorders:
rarely - hypersensitivity reactions, anaphylactic reaction; very rarely - anaphylactic shock; frequency unknown: angioedema, including swelling of the face and lips.
Metabolic and nutritional disorders:
infrequently - anorexia; very rarely polydipsia.
Mental disorders:
infrequently - sleep disturbance, insomnia;
rarely - decreased activity, depression; very rarely - confusion. Nervous system disorders:
uncommon - headache, dizziness, drowsiness; rarely - disturbance of attention, tremor, epilepsy, hypoesthesia, paresthesia, lethargy.
Visual disorders:
rarely - blurred vision.
Hearing and labyrinth disorders:
rarely - tinnitus, vertigo.
Cardiac disorders:
rarely angina pectoris, tachycardia, palpitations;
very rarely - bradycardia. Vascular disorders:
infrequently - arterial hypotension; rarely - “hot flashes”.
Disorders of the respiratory system, chest and mediastinal organs:
rarely - shortness of breath, nosebleeds, rapid breathing.
Gastrointestinal disorders:
uncommon: abdominal discomfort, dyspepsia, diarrhea, dry mouth, nausea; rarely - pain in the epigastric region, constipation, flatulence, vomiting.
Disorders of the liver and biliary tract:
rarely - mild liver failure.
Disorders of the skin and subcutaneous tissues:
rarely allergic dermatitis,
increased sweating, skin itching, skin rash, urticaria.
Musculoskeletal and connective tissue disorders:
infrequently - muscle weakness, myalgia, pain in the extremities; rarely - discomfort in the limbs; very rare osteopenia.
Renal and urinary tract disorders:
rarely - enuresis, proteinuria.
General disorders and disorders at the injection site:
infrequently - asthenia, discomfort, fatigue; rarely - a feeling of intoxication, a feeling of heat, irritability, thirst; very rarely - chest discomfort.
Laboratory and instrumental data:
rarely - decreased blood pressure, hyperbilirubinemia, changes in the activity of liver enzymes, thrombocytopenia, leukocytosis; very rarely - an increase in plasma creatinine concentration.
If any of the adverse reactions indicated in the instructions worsen, or you notice any other adverse reactions not
listed in the instructions, inform your doctor.
