Thiocetam (Tiocetam)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePiracetam + TiotriazolinPiracetam + Tiotriazolin
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  • Thiocetam
    pills inwards 
    KIEVMEDPREPARAT, OJSC     Ukraine
  • Thiocetam
    solution w / m in / in d / infusion 
    GALICHFARM, PAO     Ukraine
    • Dosage form: & nbsp

    Solution for intravenous and intramuscular injection.

    Composition:

    Composition per ml:

    Active substances: piracetam - 100.0 mg; morpholinium-methyl-triazolyl-thioacetate (tiotriazolin) 25.0 mg;

    Excipients: water for injection - up to 1 ml.

    Description:

    Transparent colorless or slightly yellowish liquid.

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X   Other psychostimulants and nootropic drugs

    Pharmacodynamics:

    Thiocetam belongs to the group of cerebroactive agents, shows nootropic, anti-ischemic and antioxidant properties. The pharmacological effect of the drug is due to the mutual potentiating action of thiotriazoline and piracetam. Pyracetam - cyclic derivative of GABA, nootropic agent; works directly on the brain, improving functions such as learning, memory, attention and consciousness without exerting sedative or psychostimulating effects. On the neuronal level piracetam facilitates various types of synaptic transmission, having a predominant effect on the density and activity of postsynaptic receptors.The hemorheological effects of pyracetam are related to its effect on erythrocytes, platelets and the vessel wall.

    Tiotriazolin reacts with the active forms of oxygen and lipid radicals due to the pronounced reducing properties of the thiol group and prevents the formation of reactive oxygen species by reactivation of antiradical enzymes: superoxide dismutase, catalase and glutathione peroxidase.

    Thiocetam improves the integrative and cognitive activity of the brain, contributes to the learning process, eliminates amnesia, improves the performance of short-term and long-term memory.

    Pharmacokinetics:Not studied.
    Indications:Chronic cerebral ischemia, the recovery period of ischemic stroke (including patients with non-cognitive impairment), diabetic encephalopathy.
    Contraindications:

    • hypersensitivity to pyracetam or thiotriazoline, as well as to other components of the drug;
    • Huntington's chorea;
    • acute violation of cerebral circulation (hemorrhagic stroke);
    • severe chronic renal failure (creatinine clearance less than 20 ml / min);
    • psychomotor agitation at the time of prescribing;
    • childhood;
    • pregnancy and lactation.

    Carefully:

    With caution, the drug is prescribed to patients with chronic renal failure (creatinine clearance 20-80 ml / min). Thiocetam affects the aggregation of platelets, so it must be used with caution in patients with hemostasis, with surgical interventions, severe bleeding.

    With caution should apply the drug to elderly people with cardiovascular pathology due to the fact that in this group of patients there are more frequent adverse reactions.

    Experience in the use of the drug for the treatment of children there, so the drug is contraindicated for the treatment of children under 18 years.

    Pregnancy and lactation:

    Experience with the drug during pregnancy or lactation is not available, so the drug should not be assigned to this category of women.

    Dosing and Administration:

    The drug is administered intravenously, intramuscularly only if it is not possible to take it inside.

    With chronic disorders of cerebral circulation and during the recovery period after ischemic stroke, 20-30 ml of the drug previously diluted in 100-150 ml of 0.9% sodium chloride solution are prescribed and injected intravenously once a day.The course of treatment is 2 weeks, then go to the tablet form.

    With diabetic encephalopathy appoint 5 ml intramuscularly once a day for 10 days with the subsequent appointment of a tablet form.

    Side effects:

    from the nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, dizziness, tinnitus, insomnia, mental agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion;

    from the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain (including gastralgia) and bloating, dry mouth;

    from the cardiovascular system: tachycardia, increased blood pressure, pain in the heart, arrhythmia, in elderly people may exacerbate coronary insufficiency;

    allergic reactions: hypersensitivity, anaphylactic reactions, including

    dermatitis, itching, hives and angioedema, fever;

    on the part of the respiratory system: shortness of breath, asthma attacks;

    from the side of metabolism: increase in body weight;

    from the organs of hearing: vertigo;

    local reactions: pain in the injection site.

    Overdose:

    Symptoms: occurrence or intensification of the manifestation of dose-dependent side effects of the drug.

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

    Thiocetam can not be simultaneously administered with drugs that have an acidic pH value. Due to the presence of piracetam, the effect of antidepressants and antianginal drugs is enhanced. With concomitant administration with thyroid hormones, confusion, irritability and sleep disturbance are possible.

    Pyracetam does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely.

    Data on the pharmaceutical incompatibility of Thiocetam with other solutions for parenteral administration are not available.

    Joint reception with alcohol did not affect the level of piracetam concentration in the serum; the concentration of ethanol in the serum did not change with the intake of 1.6 g of piracetam.

    Special instructions:

    With prolonged therapy in elderly patients, regular monitoring of kidney function is recommended, if necessary, dose adjustment is performed depending on the creatinine clearance.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (driving a car, etc.).

    Form release / dosage:

    Solution for intravenous and intramuscular injection.

    Packaging:

    5 ml or 10 ml into ampoules of colorless clear glass.

    For 10 ampoules, together with the instruction for use and scarifier ampullum is put in a box with a corrugated liner. A box is pasted with a label-parcel post.

    5 ampoules per contour-cell package made of polyvinylchloride film. Two contour-cell packs together with the instruction for use and the ampoule scarifier are put into the pack.

    When using ampoules with a dot or a ring of fracture, the insertion of scarifiers is not provided.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001618
    Date of registration:02.04.2012
    The owner of the registration certificate:GALICHFARM, PAO GALICHFARM, PAO Ukraine
    Manufacturer: & nbsp
    Representation: & nbspARTERIUM Corporation ARTERIUM Corporation Ukraine
    Information update date: & nbsp15.10.2015
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