Tizanidine-Teva
Tizanidine-Teva: 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. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Tizanidin-Teva
ATX code: M03BX02
Active ingredient: tizanidine (Tizanidine)
Producer: TEVA Pharmaceutical Works Private Limited Company (Hungary)
Description and photo updated: 2020-13-02
Prices in pharmacies: from 102 rubles.
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Tizanidine-Teva is a centrally acting muscle relaxant.
Release form and composition
The drug is available in the form of tablets: white or almost white, round, biconvex; tablets with a dosage of 2 mg on one side of the risk, on the other - engraving "T2"; tablets with a dosage of 4 mg on one side have a cruciform risk, on the other - engraving "T4" [in blisters of PVC (polyvinyl chloride film) and aluminum foil, 10 pcs., in a carton of cardboard 2, 3, 5 or 10 blisters and instructions for the use of Tizanidine-Teva].
Composition of 1 tablet:
- active substance: tizanidine - 2 or 4 mg (in the form of tizanidine hydrochloride - 2.29 or 4.58 mg, respectively);
- additional components: lactose (anhydrous lactose), ProSolv SMCC 50 [MCC (microcrystalline cellulose) 98%, colloidal silicon dioxide 2%], ProSolv SMCC 90 (MCC 98%, colloidal silicon dioxide 2%), stearic acid.
Pharmacological properties
Pharmacodynamics
Tizanidine is an agonist of α 2 -adrenergic receptors located in the central nervous system (CNS) at the spinal and supraspinal levels. The substance, in the process of stimulating presynaptic α 2 -adrenergic receptors, inhibits the release of excitatory amino acids, which have a stimulating effect on receptors that are sensitive to N-methyl-D-aspartate (NMDA receptors). This leads to the suppression of polysynaptic transmission of excitation at the level of intermediate neurons of the spinal cord. Tizanidine does not directly affect skeletal muscle, monosynaptic reflexes, or neuromuscular synapses.
Thanks to the action of tizanidine, spasticity and the incidence of clonic seizures are reduced, which in turn reduces muscle resistance to passive movements in the joints and increases the range of active movements.
Pharmacokinetics
Pharmacokinetic parameters of Tizanidine-Teva:
- absorption: the substance is well absorbed, C max (maximum concentration) in plasma is achieved in 1-2 hours. Bioavailability is 34%. Changes in the pharmacokinetics of tizanidine with food intake are not observed;
- distribution and metabolism: V d (volume of distribution) is 2.6 l / kg. The substance binds to plasma proteins by 30%. In the dose range of 4–20 mg, its pharmacokinetics are linear. The metabolic process of tizanidine proceeds quickly, it is carried out mainly in the liver (95%) with the formation of inactive metabolites;
- excretion: T 1/2 (half-life) of tizanidine varies from 3 to 5 hours. Excretion is carried out mainly with urine (unchanged - 70%, in the form of metabolites - 2.7%), to a lesser extent - with feces (20 % of the dose taken).
In patients with impaired renal function [CC (creatinine clearance) <25 ml / min] T 1/2 increases up to 14 hours, C max increases 2 times, and AUC (area under the concentration-time curve) - 6 times …
Indications for use
Tizanidine-Teva is prescribed for the following diseases / conditions:
- spasticity of skeletal muscles caused by neurological pathologies such as stroke, multiple sclerosis, degenerative diseases of the spinal cord, chronic myelopathy;
- painful spasm of skeletal muscles that occurs after surgery (for example, for osteoarthritis of the hip or herniated disc) or due to damage to the spine (lumbar and cervical syndromes).
Contraindications
Absolute:
- severe liver dysfunction;
- glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
- children and adolescence (the safety and efficacy of Tizanidine-Teva in persons under 18 years of age have not been established);
- pregnancy;
- lactation period;
- combination therapy with potent inhibitors of the CYP1A2 isoenzyme (ciprofloxacin, fluvoxamine) or α 2 -adrenomimetics;
- hypersensitivity to the active substance of the drug or other components that make up its composition.
Relative (Tizanidine-Teva is used with precautions):
- renal failure (CC <25 ml / min);
- advanced age (over 65);
- the use of oral contraceptive drugs, antihypertensive drugs, β-blockers, norfloxacin, detoxin, cimetidine, ethanol, rofecoxib, ticlopidine, diuretics, sedatives, antiarrhythmics against the background of tizanidine therapy.
Tizanidine-Teva, instructions for use: method and dosage
Tizanidin-Teva tablets are taken orally.
The doctor selects the dose and dosage regimen individually, based on the patient's needs. To facilitate swallowing, the tablet can be divided by risk.
The initial dose of tizanidine is 2 mg 3 times a day (this dosage can reduce the risk of adverse events).
Usually, the optimal result is observed when using a daily dose of 12-24 mg (should be divided into 3-4 doses). The maximum allowable daily dose is 36 mg.
The recommended dosage of Tizanidine-Teva, depending on the indications:
- spasticity of skeletal muscles caused by neurological pathologies: initial daily dose - 6 mg (should be divided into 3 doses); in the future, it can be increased by 2–4 mg, observing the intervals of 3–7 days;
- painful muscle spasm: 2-4 mg 3 times a day; if necessary, an additional intake of 2-4 mg of tizanidine is possible (preferably before bedtime, since drowsiness may increase).
The recommended dosage of Tizanidine-Teva for patients with impaired renal function (CC <25 ml / min) is 2 mg once a day. The dose should be increased gradually, taking into account parameters such as efficacy and tolerance. If it is necessary to achieve a more pronounced effect, first increase the daily dose, and then - the frequency of use.
Patients with severe hepatic impairment are not prescribed Tizanidine-Teva. In case of liver pathologies of moderate severity, the drug is used with caution, starting therapy with a minimum dose. In the future, the dose is gradually increased until the optimal balance of tolerance and treatment efficacy is achieved.
At the end of therapy, Tizanidine-Teva should not be canceled abruptly, since this can provoke the development of tachycardia and rebound hypertension. It is necessary to slowly reduce the dose until the complete withdrawal of the drug, especially in patients who have received high doses of tizanidine for a long time.
Side effects
The classification of the frequency of undesirable effects of Tizanidine-Teva is given in accordance with the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; extremely rare - less than 0.01%, including individual messages.
Taking Tizanidine-Teva tablets can lead to the following side effects:
- from the gastrointestinal tract (gastrointestinal tract): often - dryness of the oral mucosa; rarely - dysfunction of the digestive system, nausea;
- from the side of the central nervous system: often - dizziness and drowsiness; rarely - hallucinations, insomnia, sleep disorder;
- from the musculoskeletal system: rarely - muscle weakness;
- from the liver and biliary tract: very rarely - liver failure, hepatitis, transient increase in the activity of hepatic transaminases;
- from the heart and blood vessels: often - bradycardia, lowering blood pressure (blood pressure);
- other disorders: very often - increased fatigue; often - withdrawal syndrome *.
* With a sharp withdrawal of tizanidine after prolonged therapy and / or taking high doses (as well as after combined use with antihypertensive drugs), the risk of increased blood pressure and the development of tachycardia increases, and in some cases, acute cerebrovascular accident.
Overdose
Symptoms of a tizanidine overdose are drowsiness, dizziness, miosis, vomiting / nausea, anxiety, prolongation of the QTc interval, a marked decrease in blood pressure, respiratory failure, coma.
If an overdose is suspected, gastric lavage and forced diuresis are performed, activated charcoal is prescribed (repeatedly), in the future - symptomatic treatment. During therapeutic measures, the patient should drink plenty of fluids.
special instructions
The use of the drug Tizanidin-Teva in patients with impaired renal function (CC <25 ml / min) requires caution. They may need a dose reduction.
Patients taking tizanidine in a daily dose of 12 mg or more are recommended to monthly monitor the functional parameters of the liver during the first four months. Such monitoring is also required in the presence of clinical signs that allow one to suspect liver dysfunction, including fatigue, anorexia, and unexplained nausea. If the activity of hepatic transaminases exceeds the upper limit of the norm by 3 times or more, it is necessary to stop using Tizanidine-Teva.
The combined use of inhibitors of the isoenzyme CYP1A2 with tizanidine can lead to an increase in the concentration of the latter in the blood plasma, which can cause the development of symptoms of an overdose, for example, prolongation of the QTc interval. For this reason, taking Tizanidine-Teva concurrently with inhibitors of the isoenzyme CYP1A2 and other drugs that can prolong the QTc interval is not recommended.
Patients with coronary artery disease (ischemic heart disease) and other diseases of the cardiovascular system should be careful when taking tizanidine. Patients of this category need regular monitoring of laboratory indicators of the functional state of the heart and monitoring of ECG indicators (electrocardiogram).
It is necessary to cancel Tizanidine-Teva gradually in order to avoid the development of withdrawal syndrome.
Clinical studies have confirmed the absence of a negative effect of tizanidine on the strength of muscle contraction. However, there are reports of rare cases of muscle weakness during drug therapy.
Influence on the ability to drive vehicles and complex mechanisms
Therapy with Tizanidine-Teva is accompanied by the development of such side effects from the central nervous system as dizziness and drowsiness. Which can adversely affect the ability to drive vehicles and perform potentially hazardous activities. In this regard, patients, whose activities require the speed of psychomotor reactions and increased concentration of attention, must be careful while using the drug.
Application during pregnancy and lactation
Tizanidin-Teva tablets are not prescribed for pregnant and breastfeeding women.
Pediatric use
Tizanidine-Teva is contraindicated in children and adolescents under the age of 18.
With impaired renal function
In renal failure (CC <25 ml / min), Tizanidine-Teva tablets are used with caution.
The recommended dosage for patients in this category is 2 mg once a day.
For violations of liver function
In severe hepatic dysfunction, Tizanidine-Teva is contraindicated.
Patients with moderate hepatic impairment need to be careful when starting tizanidine therapy with the lowest dose.
Use in the elderly
Elderly patients (over 65 years of age) should be prescribed the drug with caution, carefully monitoring kidney function, since in patients of this age category, the glomerular filtration rate may slow down.
Treatment should be started with the minimum dose and gradually increased until the optimal ratio of therapy efficacy and tolerability of the prescribed dosage regimen is achieved.
Drug interactions
Concomitant use of tizanidine with other substances / drugs may lead to the development of the following drug interactions:
- ciprofloxacin, fluvoxamine and other powerful inhibitors of the CYP1A2 isoenzyme: significantly increase the concentration of tizanidine in the blood plasma, which entails an increased risk of adverse reactions;
- diuretics and other antihypertensive drugs: the risk of developing bradycardia and a pronounced decrease in blood pressure increases;
- antiarrhythmic drugs, oral contraceptives, rofecoxib, cimetidine, ticlopidine, norfloxacin: significantly reduce the clearance of tizanidine;
- ethanol, sedatives: the risk of CNS depression increases;
- paracetamol: increases the time to reach the maximum concentration of the substance in the plasma by 16 minutes (this interaction has no clinical significance).
Analogs
Tizanidin-Teva analogs are Tizalud, Tizanil, Tizanidin, Tizanidin-SZ, Sirdalud, Sirdalud MR, etc.
Terms and conditions of storage
Keep out of the reach of children. The temperature at the storage location should not exceed 25 ° C.
The shelf life is 3 years. After the expiration of the period indicated on the package, the drug must not be used.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tizanidine-Teva
On the Internet, you can find many positive reviews about Tizanidine-Teva. Almost all patients note the high efficacy of the drug in eliminating severe pain. The action of the drug manifests itself quickly, after 10-20 minutes after taking it, relief comes, muscle spasm relieves, pain and stiffness disappear. Users consider the low cost of the product and its availability in pharmacy chains as an additional plus.
The disadvantage of Tizanidine-Teva, according to most patients, is such a side effect as drowsiness, as well as the fact that pills can only be purchased with a prescription.
The price of Tizanidin-Teva in pharmacies
In pharmacy chains, the price of Tizanidin-Teva is per pack of 30 pcs. is 119-145 rubles. (tablets with a dosage of 2 mg) or 154-206 rubles. (tablets with a dosage of 4 mg).
Tizanidine-Teva: prices in online pharmacies
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Drug name Price Pharmacy |
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Tizanidine-Teva 2 mg tablets 30 pcs. 102 RUB Buy |
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Tizanidine-Teva 4 mg tablets 30 pcs. 142 RUB Buy |
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!
