Tizalud (Tisalud)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTizanidineTizanidine
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    • Dosage form: & nbsppills
    Composition:
    Active substance: Tizanidine hydrochloride - 2.288 mg and 4.576 mg in terms of tizanidine - 2.0 mg and 4.0 mg;
    Excipients:
    [Lactose anhydrous (lactopress)
    117.012 mg and 234.024 mg, Microcrystalline cellulose 14.0 mg and 28.0 mg, Carboxymethyl starch sodium
    (Primogel) 4.2 mg and 8.4 mg, Magnesium stearate 2.5 mg and 5.0 mg].
    Weight of the tablet is 140.0 mg and 280.0 mg.

    Description:
    Tablets are white or white with a yellowish hue, round, biconvex with a risk.

    Pharmacotherapeutic group:Miorelaxant of central action
    ATX: & nbsp

    M.03.B.X   Other muscle relaxants of central action

    M.03.B.X.02   Tizanidine

    Pharmacodynamics:
    Miorelaxapt of central action. The main point of the application is in the spinal cord. Stimulating presynaptic alpha2-adrenergic receptors, tizanidine suppresses the excretion of excitatory amino acids from the intermediate neurons of the spinal cord,which leads to inhibition of the polysynaptic transmission of excitation in the spinal cord. As a result, there is a decrease in muscle tone. In addition to the muscle relaxant properties tizanidine also has a central moderately pronounced analgesic effect.
    Effective against acute painful muscle spasms and chronic spasms of spinal and cerebral origin. Reduces spasticity and clonic convulsions, resulting in reduced resistance to passive movements and increases the volume of active movements.

    Pharmacokinetics:
    Absorption is high; the time to reach the maximum plasma concentration (Cmах) - 1-2 hours Bioavailability - 34%. The intake of food does not affect the pharmacies of the net. The volume of distribution is 2.6 l / kg. Connection with plasma proteins - 30%. In the dosage range of 4 to 20 mg, the pharmacokinetics are linear. Metabolized quickly and largely in the liver (95%) with the formation of inactive metabolites. The half-life (T1 / 2) is 2-4 hours. It is mainly excreted by the kidneys (70% of the dose in the form of metabolites, 2.7% in the unchanged form). In patients with renal insufficiency (CC less than 25 ml / min), the maximum concentration in blood plasma (Cmax) increases in 2 times, T1 / 2 - 14 hours,the area of ​​the pharmacokinetic curve "concentration-time" (AUC) increases 6-fold.

    Indications:
    painful muscular spasm associated with static and
    functional diseases of the spine (cervical and lumbar syndromes), as well as after surgical interventions (for example, about a herniated intervertebral disc or osteoarthrosis of the hip joint);
    spasticity of skeletal muscles in neurological diseases (for example, with multiple sclerosis, chronic myelopathy, degenerative diseases dorsal brain, consequences of cerebral circulation disorders, as well as in children's cerebral palsy (patients over 18 years old).

    Contraindications:
    marked violation of liver function;
    - simultaneous application with strong inhibitors of isoenzymes CYP1A2 (incl. fluvoxamine, ciprofloxacin);
    -increased sensitivity to tizanidine, other components of the drug;
    -related hereditary lactose intolerance, severe lactase deficiency, glucose-galactose malabsorption (for a given dosage form containing lactose);
    The use of tizanidine in children (under 18 years of age) is not recommended;the experience of using the drug in this category of patients is limited.

    Carefully:
    renal failure, arterial hypotension,
    bradycardia, simultaneous intake of oral contraceptives, age over 65 years
    Pregnancy and lactation:
    Since controlled studies of the use of tizanidine in pregnant women have not been conducted, it should not be used in pregnancy, except when the expected benefit to the mother exceeds the possible risk to the fetus.
    Tizanidn is excreted in breast milk in small amounts. Nevertheless, if you need to use tizanidine during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:
    Kupirovanie a painful muscular spasm: inside, 2-4 mg 3 times a day, in severe cases - additionally at night 2-4 mg.
    Treatment of spasticity caused by neurological diseases: the initial dose is 2 mg 3 times a day, then the dose is gradually increased by 2-4 mg at intervals of 3-7 days. The optimal daily dose is 12-24 mg in 3-4 doses; the maximum daily dose is 36 mg.
    Patients with renal insufficiency (with QC less than 25 ml / min) the recommended initial dose is 2 mg I once a day.Increase in the dose is carried out gradually, slowly, taking into account the portability and effectiveness. If
    it is necessary to obtain a more pronounced effect, it is recommended first to increase the dose prescribed once a day, then increase the multiplicity of the appointment.

    Side effects:
    From the nervous system: drowsiness, dizziness, hallucinations, insomnia, sleep disturbances.
    From the cardiovascular system: bradycardia, lowering of arterial pressure (in some cases expressed, up to collapse and loss of consciousness).
    On the part of the digestive system: dry mouth, nausea, dyspepsia, increased activity of "liver" transaminases, hepatitis, hepatic insufficiency.
    From the musculoskeletal system: muscle weakness.
    Other: increased fatigue, hypercreatininaemia.
    With a sharp cancellation after prolonged treatment and / or taking high doses of the drug (and also after simultaneous application together with antihypertensive drugs): tachycardia, increased blood pressure, in some cases - acute disturbance of cerebral circulation.

    Overdose:
    Symptoms: nausea, vomiting, marked decrease in blood pressure, dizziness,
    drowsiness, miosis, anxiety, respiratory failure, coma.
    Treatment: gastric lavage, the appointment of activated charcoal, conducting forced diuresis, symptomatic therapy.

    Interaction:
    Simultaneous use of tizanidine with fluvoxamine or ciprofloxacin, inhibitors of isofermite 1A2 cytochrome P450, leads to a 33-fold increase in the aUC of tizanidine. The result of a combined application may be a clinically significant and prolonged decrease in blood pressure, leading to drowsiness, weakness, inhibited psychomotor reactions (in some cases, up to collapse and loss of consciousness).
    It is not recommended simultaneous use of tizanidine with other inhibitors of the isoenzyme CYP1A2 - antiarrhythmic drugs (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, ticlopidine.
    Antihypertensive drugs (LS) increase the risk of a marked decrease in blood pressure and bradycardia.
    Ethanol, sedative drugs can enhance the sedative effect of tizanidine, therefore, simultaneous use with other sedatives and / or alcohol is not recommended.

    Special instructions:
    It is recommended to monitor liver function once a month for the first 4 months of treatment, in those patients who are assigned tizanidine in a daily dose of 12 mg and above, as well as in those cases when there are clinical signs suggesting a violation of liver function, such as unexplained nausea, anorexia, a feeling of fatigue. In the case when the activity of aspartate aminotransferase (ACT) and alanine aminotransferase (ALT) persistently exceeds the upper limit of the norm by 3 times or more, the reception of tizanidine is stopped.
    Patients with the syndrome of congenital extension of the Q-T interval tizanidine should be administered with caution. in pre-clinical studies of chronic toxicity in animals (dogs), the Q-T interval was prolonged when the drug was administered at a dose equivalent to the maximum dose for a human. Because of the threat of the "cancellation" syndrome, the dose of tizanidine is reduced gradually.
    During treatment, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Effect on the ability to drive transp. cf. and fur:
    During treatment, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    Tablets of 2 mg and 4 mg. For 10 tablets in a planar cell pack of a polyvinyl chloride film and aluminum foil printed lacquered.
    30 tablets in a jar of polymer materials with a screw neck and lid screwed from polypropylene and polyethylene of low pressure.
    Each bank or 3 contour mesh packages together with instructions for use in a pack of cardboard.

    Packaging:
    For 10 tablets in a planar cell pack of a polyvinyl chloride film and aluminum foil printed lacquered.
    30 tablets in a jar of polymer materials with a screw neck and lid screwed from polypropylene and polyethylene of low pressure.
    Each bank or 3 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children
    Shelf life:
    2 years
    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009885/09
    Date of registration:04.12.2099
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.08.2015
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