Tizanidine-Teva 4mg tab 30 pc


Tizanidine-Teva 4mg tab 30 pc


SKU: 1386986010 Categories: , , Tags: , ,


Active substance:
1 tablet contains: Tizanidine hydrochloride (tizanidine) 2.29 mg (2.0 mg) or 4.58 mg (4.0 mg) ;.
Lactose (Lactose Anhydrous) 57.91 mg / 115.82 mg; SMCC proSolv 501 (98% microcrystalline cellulose, colloidal silicon dioxide 2%) 22.575 mg / 45.15 mg; SMCC proSolv 901 (98% microcrystalline cellulose, colloidal silicon dioxide 2%) 22.575 mg / 45.15 mg; stearic acid 2.150 mg / 4.30 mg.
2 mg tablets. Round biconvex tablets of white or almost white color with the mark on one side and chasing “T2” – to another.
4 mg tablets. Round biconvex tablets of white or almost white color with a cruciform mark on one side and chasing “T4” – to another.
Product form:
Tablets 2 mg or 4 mg.
Packaging 30 tablets.
Hypersensitivity to tizanidine or other components of the formulation; pregnancy; breastfeeding; age 18 years (effectiveness and safety have been established); expressed human liver; simultaneous application of potent inhibitors isoenzyme CYP1A2 (fluvoxamine, ciprofloxacin), alpha2-agonists, lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Patients older than 65 years; renal failure (creatinine clearance less than 25 mL / min); simultaneous application of oral contraceptive preparations, antiarrhythmics, cimetidine, norfloxacin, rofecoxib, ticlopidine, detoksinom, beta-blockers, sedatives, ethanol, diuretics, hypotensive drugs.
4 mg
Skeletal muscle spasticity in multiple sclerosis, spinal cord injuries.
Interaction with other drugs
The simultaneous use of potent inhibitors isoenzyme CYP1A2 (fluvoxamine, ciprofloxacin) significantly increases the concentration of tizanidine in plasma and increases the likelihood of side reactions.
Antihypertensive drugs, including diuretics, while the use of tizanidine increase the risk of pronounced reduction in blood pressure and bradycardia.
While the use of oral contraceptive preparations, antiarrhythmics, cimetidine, norfloxacin, rofecoxib, ticlopidine significantly reduced clearance tizanidine.
While the use of sedatives and tizanidine ethanol increased risk of depression of the central nervous system.
Paracetamol increases TSmah 16 min (no clinical significance).
Symptoms include nausea, vomiting, a marked reduction of blood pressure, lengthening the interval QT (c), dizziness, drowsiness, miosis, anxiety, respiratory failure, coma.
Treatment: gastric lavage, repeated application of activated carbon, conducting forced diuresis, symptomatic therapy, receiving large quantities of liquid.
pharmachologic effect
Tizanidine is an agonist of alpha2-adrenergic receptors in the central nervous system at the supraspinal and spinal levels. Stimulating the presynaptic alpha-2 adrenoceptors, tizanidine suppresses the release of excitatory amino acids to stimulate receptors sensitive to N-methyl-D-acpaptatu (NMDA-receptors). Consequently, at the level of intermediate neurons of the spinal cord is suppressed polysynaptic transmit excitation. Tizanidine has no direct effect on skeletal muscle, the neuromuscular junction or monosynaptic reflexes.
Tizanidine reduces spasticity and clonic convulsions, thereby reducing resistance to passive movements of muscles and joints increases the amount of active movements.
Absorption tizanidine is high, the time to reach maximum plasma concentration (TSmah) – 1-2 hours Bioavailability -. 34%. Eating does not affect the pharmacokinetics.
Distribution and metabolism.
The volume of distribution – 2.6 l / kg. Relationship to plasma proteins – 30%.
In the dose range from 4 to 20 mg is linear pharmacokinetics. Tizanidine is rapidly metabolized to a great extent in the liver (95%) with the formation of active metabolites.
The half-life (T1 / 2) -. 3-5 hours is derived primarily by the kidneys (70% – unchanged, 2.7% – in the form of metabolites) and excreted with feces (20%).
In patients with renal failure (creatinine clearance (CC) of less than 25 ml / min), the maximum plasma concentration (Cmax) increases 2 times, T1 / 2 14 h, area under the curve “concentration-time” (AUC) increased in 6 time.
Pregnancy and breast-feeding
Use during pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often – at least 10%; often – at least 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rarely – 0.01%, including isolated reports.
From the nervous system: often – drowsiness, dizziness; rarely – insomnia, hallucinations, sleep disorder.
Cardio-vascular system: often – a decrease in blood pressure, bradycardia.
From the digestive system, often – dryness of the oral mucosa, is rarely – nausea, impaired GI function.
Of the liver and biliary tract: rarely – transient increase in activity of “liver” transaminases, hepatitis, liver failure.
On the part of the musculoskeletal system: rarely – muscle weakness.
Other: often – fatigue; often – syndrome “cancel” *
* When sharp cancellation after prolonged treatment and / or receiving high doses (and also after use with antihypertensive drugs) increases the risk of tachycardia, increased blood pressure, in some cases – acute ischemic stroke.
special instructions
Caution must be exercised when using the drug-Teva tizanidine in renal failure patients. In applying the drug-Teva tizanidine in patients with renal failure (creatinine clearance less than 25 mL / min) may require dose reduction. It is recommended to monitor the functional parameters of the liver 1 time per month during the first 4 months of treatment in those patients who take the drug tizanidine-Teva in a daily dose of 12 mg and above, as well as in cases where the clinical signs suggestive of liver dysfunction such as unexplained nausea, anorexia, fatigue. In the case where the activity of “liver” transaminases above upper limit is 3 times or more, the use of drug-Teva tizanidine should be discontinued.
With the simultaneous application of the drug-Teva tizanidine with inhibitors of CYP1A2 isoenzyme may increase tizanidine concentration in blood plasma, which in turn may be the cause of the symptoms of an overdose, particularly QT (c) interval elongation. The simultaneous use of a preparation of tizanidine-Teva isoenzyme CYP1A2 inhibitors and other drugs that may lead to a lengthening of the interval QT (c), is not recommended.
Tizanidine in the treatment of patients with cardiovascular disease, coronary heart disease should be careful. Should regularly monitor the laboratory parameters of the functional state of the heart and ECG monitor.
Abolition of the drug tizanidine-Teva should be done gradually because of the risk of the syndrome of “lifting” (see. Section “Side effects”).
It was reported about rare cases of muscle weakness in the application of tizanidine (see. Section “Side effects”). In clinical studies it was shown that tizanidine has no negative influence on the strength of muscle contraction.
Effects on ability to transport management and work with technology.
Caution should be exercised when using the drug tizanidine-Teva due to the potential for adverse reactions that may adversely affect the ability to drive vehicles and the performance of potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside. The initial dose was 2 mg, followed by increasing doses of 2 mg at intervals of at least 3-4 days.
The maximum daily dose – 36 mg.
The dosage regimen should be installed individually, the daily dose is divided into several stages (3-4), depending on the patient’s needs. Usually not require the use of more than 24 mg / day.
Treatment of patients with renal impairment (creatinine clearance less than 25 mL / min) is recommended to start with a dose of 2 mg 1 time per day. Increasing doses should be performed gradually, taking into account the tolerability and effectiveness of: initially increase the dose, and then increase the multiplicity of applications.
In patients older than 65 years of drug tizanidine-Teva should be used under close monitoring of renal function due to a possible decrease in the glomerular filtration rate.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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