Active substanceThiethylperazineThiethylperazine
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  • Torekan
    pills inwards 
  • Torekan
    suppositories rect. 
  • Torekan
    solution w / m in / in 
  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:
    1 ml of the solution contains:
    Active substance:
    Thiethylperazine dimalate 10,86 mg
    (equivalent to 6.5 mg of thiethylperazine)
    Excipients:
    Ascorbic acid 0,50 mg
    Sorbitol 40,00 mg
    Sodium disulfite 0,50 mg
    (sodium metabisulphite)
    Water for injections q.s. up to 1.00 ml

    Description:Transparent colorless or slightly yellowish solution.
    Pharmacotherapeutic group:antiemetic
    ATX: & nbsp

    R.06.A.D.   Phenothiazine derivatives

    R.06.A.D.03   Thiethylperazine

    Pharmacodynamics:
    Antiemetic central action (piperazine phenothiazine derivative) blocks Hi - histamine receptors and dopamine receptors in the nigrostriatal tract, almost no antipsychotic action. Has alpha-adrenergic blocking effect and m-cholinoblocking action. It acts on the chemoreceptor trigeminal zone and the vomiting center. Eliminates dizziness, affecting the focal points in the reticular formation. The effect develops rapidly, usually after the first use of thiethylperazine.

    Pharmacokinetics:
    Absorption Absorption is high.
    The maximum concentration is reached after 2 to 4 hours.
    Distribution
    Lipophilin and strongly binds to blood plasma proteins (over 85%). It accumulates in organs with good blood flow and easily penetrates the placenta. The volume of distribution is 2.7 l / kg. Not output by dialysis.
    Metabolism and excretion
    Metabolized mainly in the liver. Only 3% is excreted by the kidneys unchanged. The half-life (T1 / 2) is approximately 12 hours.

    Indications:Treatment and prevention of nausea and vomiting after surgery, craniocerebral trauma, chemo- and radiation therapy, with diseases of the gastrointestinal tract, liver and bile ducts, drug intolerance; sea ​​and air sickness; dizziness of the central and vestibular genesis (concussion, atherosclerosis, vestibular and labyrinthine disorders, Meniere's disease).
    Contraindications:
    Hypersensitivity to thiethylperazine, phenothiazines or any of the auxiliary components of the drug, severe CNS depression and / or consciousness disorder, clinically significant hypotension, angle-closure glaucoma (acute attack), renal and / or hepatic insufficiency,blood diseases, bronchial asthma, prostatic hypertrophy, Parkinson's disease and parkinsonism, pregnancy, the period of breastfeeding, children under 15 years of age (risk of extrapyramidal disorders), Reye syndrome, prolactinoma, concomitant use with bromocriptine.

    Pregnancy and lactation:
    Data on the use of thiethylperazine in pregnant women are absent. Torekan should not be used during pregnancy, except when the benefits to the mother exceed the potential risk to the fetus.
    Data on the isolation of thiethylperazine with breast milk are not available, therefore, if you need to use Torekan during lactation, breastfeeding should be discontinued.

    Dosing and Administration:
    Adults and children over 15 years.
    The recommended dose of thiethylperazine for adults is 6.5 - 13 mg per day.
    Usually, the drug is administered intramuscularly.
    To prevent postoperative vomiting, the contents of 1 ampoule are administered intramuscularly at a dose of 6.5-13 mg 30 minutes before the end of the operation.
    Intravenous use of the drug Torekan is possible in exceptional cases and very slowly, due to the risk of developing arterial hypotension.
    Never inject the drug Torekan intraarterially. For parenteral administration (including intramuscular), it is recommended to move the patient to a horizontal position. Within 1 hour after the introduction, careful monitoring is required.
    Renal and / or hepatic insufficiency
    The dosage regimen in patients with renal and / or liver failure is not accurately determined, however, in this category of patients, a dose reduction is recommended. The duration of treatment depends on the course of the disease. Usually, Torekan is prescribed for one day. If necessary, treatment can be continued up to several days or weeks.
    Elderly patients
    Treatment of patients older than 75 years should not continue for more than 2 months due to the risk of involuntary movements (tardive dyskinesia).

    Side effects:
    Classification of the incidence of adverse events (WHO):
    very often> 1/10
    often from> 1/100 to <1/10
    infrequently from> 1/1000 to <1/100
    rarely from> 1 / 10,000 to <1/1000
    very rarely from <1/10000, including individual messages.
    From the cardiovascular system:
    rarely: peripheral edema, orthostatic hypotension;
    very rarely: tachycardia, lowering blood pressure, changing the T wave on the ECG;
    From the nervous system.
    infrequently: headache, dizziness, drowsiness, restlessness;
    rarely: seizures or extrapyramidal disorders (torticollis, opisthotonus,
    oculogic crisis (spasm of eyesight), rigidity of muscles, grimaces) - more often in children and adolescents; in elderly patients after prolonged use of the drug may develop tardive dyskinesia (involuntary movements);
    very rarely: neuralgia of the trigeminal nerve, paradoxical reactions ("nightmarish" dreams, unusual agitation, nervousness, irritability);
    From the sense organs:
    rarely: clouding of the lens, miosis, decreased vision, retinal pigmentation;
    From the digestive system:
    rarely: anorexia, dryness of the oral mucosa, constipation;
    very rarely: cholestatic jaundice, paralytic intestinal obstruction, impaired liver function;
    From the endocrine system:
    rarely: gynecomastia, menstrual irregularities, changes in libido, weight gain;
    From the skin:
    very rarely: exfoliative dermatitis, photosensitivity;
    Allergic reactions:
    very rarely: allergic reactions;
    Laboratory indicators:
    Very rarely: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, pancytopenia;
    Other:
    very rarely: impaired renal function.

    Overdose:
    Symptoms: dryness of the oral mucosa, dizziness, confusion, postural hypotension, collapse.
    In severe intoxication - coma, areflexia, tachycardia and respiratory depression, acute dystonia, convulsions, agitation.
    Treatment: symptomatic, there is no specific antidote. Recommended gastric lavage, the use of activated charcoal. In other cases, vital functions should be monitored. For the treatment of dystonic reactions, anti-Parkinsonics are used, benzodiazepines are used for the treatment of convulsions, plasma substitutes and vasopressors are used to combat circulatory insufficiency (adrenaline should not be used, noradrenaline can be used).
    Hemodialysis is ineffective.

    Interaction:
    Thiethylperazine can enhance the action of CNS depressants, including tranquilizers, opioids, anesthetics, hypnotics and ethanol.
    Tricyclic antidepressants and thiethylperazine can enhance the action and toxicity of each other.
    Thiethylperazine can reduce the effectiveness of adrenaline, so epinephrine should not be used to treat arterial hypotension caused by thiethylperazine. The simultaneous use of thiethylperazine and bromocriptine reduces the inhibitory effect of bromocriptine on the secretion of prolactin. Therefore, the use of thiethylperazine is not recommended for patients with prolactinoma receiving bromocriptine. Simultaneous use of MAO inhibitors and phenothiazines can lead to an increase in undesirable effects of MAO inhibitors (hypotension, respiratory depression and CNS). Phenothiazines can enhance the undesirable effects of procarbazine.

    Special instructions:
    Thiethylperazine eliminates and prevents nausea and vomiting after chemotherapy with drugs with mild or moderate side effect in the form of vomiting (for example, fluorouracil), but is weakly effective when using drugs with a pronounced emetic effect (for example, cisplatin).
    Like other antiemetics, Torekan can mask the symptoms of certain gastrointestinal and CNS diseases, as well as the toxic effects of other medicines.
    In connection with the additive hypotensive effect of thiethylperazine, it should be used with caution in patients with spinal anesthesia and patients taking beta-blockers simultaneously. Hypotensive effect of the drug Torekan is dangerous in pregnant women with preeclampsia in connection with the risk of a significant decrease in blood pressure.
    Torekan should be used with caution in patients with dyskinesia and in patients with moderate or severe impairment of liver function.
    Phenothiazines can cause malignant neuroleptic syndrome, the clinical manifestations of which are hyperpyrexia, muscle stiffness, mental disorders and signs of a disorder of the autonomic nervous system. In such cases, Torekan should be discontinued immediately.
    In elderly patients it is recommended to limit the duration of treatment with Torekan 2 months.
    Special information about some ingredients
    Torekan contains sorbitol (E420) and sodium metabisulphite (E223). Sodium metabisulfite can cause a severe hypersensitivity reaction and bronchospasm.
    The drug contains less than 1 mmol sodium (23 mg) in a single dose, i.e.can be regarded as a drug "not containing sodium."
    Effect on the ability to drive transp. cf. and fur:
    drug Torekan has a pronounced effect on psychomotor reactions, and therefore, during treatment should abandon the management of vehicles and work with technical devices that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    The solution for intravenous and intramuscular administration is 6.5 mg / ml.

    Packaging:
    1 ml of the drug in a neutral glass ampoule (type 1, Ph.Eur.). The ampoule has a colored dot that indicates the line of the ampoule fracture and the color coding ring.
    5 ampoules are placed in a blister of PVC - aluminum foil. 1 blister in a pack of cardboard along with instructions for use.

    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:5 years.
    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012413 / 03
    Date of registration:20.07.2011
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    Information update date: & nbsp12.09.2015
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