Active substanceTrifluoperazineTrifluoperazine
Similar drugsTo uncover
  • Triftazine
    pills inwards 
  • Triftazine
    solution w / m 
  • Triftazine
    pills inwards 
    DALHIMFARM, OJSC     Russia
  • Triftazine
    solution w / m 
    DALHIMFARM, OJSC     Russia
  • Triftazin-Darnitsa
    solution w / m 
  • Dosage form: & nbspcoated tablets
    Composition:

    Composition of one tablet:

    Active substance: Trifluoperazina dihydrochloride (triftazine hydrochloride) in terms of triftazine base - 0,0050 g / 0,0100 g.

    Excipients: sucrose (sugar) - 0.115088 g / 0.257976 g, potato starch - 0.035000 g / 0.070000 g, silicon dioxide colloid (aerosil) - 0.002748 g / 0.005496 g, calcium stearate - 0, 001000 g / 0.002000 g, gelatin 0.000065 g / 0.000130 g, povidone (low molecular weight medical polyvinylpyrrolidone 12600 ± 2700) 0.002666 g / 0.005332 g, magnesium hydroxycarbonate (magnesium carbonate basic) - 0,017102 g / 0,034204 g, titanium dioxide (titanium dioxide pigment) - 0.000350 g / 0.000700 g, talc - 0.000499 g / 0.000998 g, indigocarmine - 0.000308 g / 0.000616 g, beeswax - 0.000174 g / 0.000348 g.

    Description:The tablets covered with a shell of blue color with marble, biconvex, round, with a smooth surface. Tablets on a cross-section of white with a creamy shade of color.
    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.B.06   Trifluoperazine

    Pharmacodynamics:Antipsychotic agent (neuroleptic), piperazine derivative of phenothiazine. Possesses also sedative, antimycotic, cataleptic, hypotensive, hypothermiaand weak m-anticholinergic action.

    The antipsychotic effect is due to the blockade of the D2-dopamine receptors of the mesolimbic and mesocortical system, has a blocking effect on alpha-adrenergic receptors and inhibits the release of hormones of the hypothalamus and pituitary gland (the proliferation of the prolapse by the pituitary gland increases with the blockade of dopamine receptors). Blockade of alpha-adrenergic receptors of blood vessels determines its hypotensive effect. Antiemetic action - blockade of peripheral and central (chemoreceptor trigger zone of the vomiting center of the cerebellum) D2dopamine receptors, as well as blockade of the endings of the vagus nerve in the gastrointestinal tract.

    Sedative action is due to blockade of adrenoreceptors of the reticular formation of the brain stem.

    Hypothermic action - blockade of dopamine receptors of the hypothalamus.

    Structurally similar to chlorpromazine, has a higher activity, better tolerated.Sedative action and influence on the autonomic nervous system is less pronounced than in other phenothiazine derivatives, extrapyramidal and antiemetic effects are stronger.

    Pharmacokinetics:

    Absorption is high. Bioavailability after oral administration - 35% (has the effect of "first passage" through the liver). The connection with plasma proteins is 95%. The time it takes to reach a maximum concentration of -2-4 hours. It penetrates the blood-brain barrier, the placenta and into breast milk. Intensively metabolized in the liver, metabolites are pharmacologically inactive. The half-life is 15-30 hours. It is excreted mainly by kidneys (in the form of metabolites) and with bile. During hemodialysis dialysis is poorly (high bond with plasma proteins).

    Indications:

    Schizophrenia (with productive and negative symptoms) and other psychotic diseases that occur with psychomotor agitation, hallucinatory and delusional disorders.

    Contraindications:Hypersensitivity to the components of the drug (including other phenothiazine derivatives), severe cardiovascular diseases (decompensated chronic heart failure, arterial hypotension), pronounced oppression of the function of pricesof the nervous system (incl.. amid drugs) and comatose states of any etiology, traumatic brain injury, progressive brain and spinal cord diseases, inhibition of bone marrow hematopoiesis, impaired hematopoiesis, severe hepatic impairment, childhood.

    Carefully:

    Alcoholism (increased susceptibility to hepatotoxicity), angina, valvular heart disease, limiting the amount of minute blood circulation (development of severe arterial hypotension), breast cancer (as a result of induced phenothiazine prolactin increases the potential risk of disease progression and treatment resistance endocrine and cyto - static drugs), closed-angle glaucoma, prostatic hyperplasia with clinical manifestations, ne malnutrition of mild and moderate degree, renal insufficiency, peptic ulcer of the stomach and duodenum in the period of exacerbation; diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease (extrapyramidal effects are intensified); epilepsy; myxedema; chronic diseases,accompanied by a violation of breathing (especially in children); Reye syndrome (increased risk of manifestations of hepatotoxicity in children and adolescents); cachexia, vomiting (antiemetic effect of phenothiazines may mask vomiting associated with overdose of other medicines), elderly age. When taking the drug should avoid exposure to high temperatures (possibly a violation of thermoregulation).

    Malignant neuroleptic syndrome can occur at any time during treatment with neuroleptics and lead to death.

    Pregnancy and lactation:

    The drug is contraindicated during pregnancy and during breastfeeding.

    Dosing and Administration:

    Is taken orally after a meal. Doses are selected individually according to the severity of the condition. When the maximum therapeutic effect is achieved, the dose is gradually reduced to a maintenance dose.

    In psychotic diseases, usually prescribed 5 mg 2 times a day, then within 2-3 weeks the dose is gradually increased to 15 - 20 mg per day divided by 2 to 3 doses. To obtain the desired therapeutic effect and improve the condition of pait usually takes 2-3 weeks. The maximum daily dose is 40 mg.

    At the first stage of dose selection in elderly, emaciated, weakened patients and children, it is advisable to use dosage forms with a lower dosage of trifluoperazine. Elderly, as well as debilitated and debilitated patients, a smaller initial dose is required, which is gradually increased if necessary, taking into account the tolerance.

    Side effects:

    From the nervous system: drowsiness, dizziness, insomnia (at the beginning of treatment), with prolonged use in high doses (0.5-1.5 g / day) - akathisia, dystonic extrapyramidal reactions (spasms of the muscles of the face, neck and back, tick-like movements or twitches, the movement of the trunk, the inability to move the eyes, weakness in the arms and legs), parkinsonism (difficulty in speaking and swallowing, loss of balance control, masklike face, shuffling gait, stiffness of hands and feet, trembling of hands and fingers), tardive dyskinesia (smacked and wrinkled lips, cheeks inflating, rapid or vermiform movements of the tongue, uncontrolled chewing movements, uncontrolled movements of hands and feet),malignant neuroleptic syndrome (convulsions, difficulty or rapid breathing, palpitations or irregular heartbeats, hyperthermia, unstable blood pressure, increased sweating, loss of control of urination, severe muscle stiffness, unusually pale skin, excessive fatigue and weakness), psychic indifference, late reactions to external stimuli and other changes in the psyche, convulsions.

    From the genitourinary system: retention of urine, decreased potency, frigidity (at the beginning of treatment), decreased libido, ejaculatory disorders, priapism, oliguria.

    From the endocrine system: hypo- or hyperglycemia, hyperprolactinaemia, galactorrhea, swelling or pain in the mammary glands, gynecomastia, amenorrhea, dysmenorrhea, weight gain.

    From the digestive system: loss of appetite, dry mouth, constipation (at the beginning of treatment), bulimia or anorexia, nausea, vomiting, diarrhea, gastralgia, cholestatic jaundice, hepatitis, intestinal paresis.

    From the sense organs: visual impairment - paresis of accommodation (at the beginning of treatment), retinopathy, clouding of the lens and cornea, blurred vision.

    From the hematopoiesis: oppression of bone marrow hematopoiesis (thrombocytopenia, leukopenia, agranulocytosis (for 4-10 weeks of treatment), pancytopenia, eosinophilia), hemolytic anemia.

    Laboratory indicators: false positive tests for pregnancy and phenylketonuria.

    From the cardiovascular system: tachycardia, lowering of blood pressure (including orthostatic hypotension) especially in elderly patients and people with alcoholism (at the beginning of treatment), heart rhythm disturbances, lengthening of the interval Q-T, a decrease or inversion of the T wave, an increase in angina attacks (against the background of increased physical activity).

    Allergic reactions: skin rash, hives, exfoliative dermatitis, angioedema.

    Other: coloring of the skin from blue-violet to brown, photosensitization, discoloration of the sclera and cornea, a decrease in the tolerance of exposure to high temperatures (up to the development of heat stroke - hot dry skin, loss of sweating, confusion), myasthenia gravis.

    Overdose:

    Symptoms: areflexia or hyperreflexia, blurred vision, cardiotoxic (arrhythmia, heart failure, lowering of arterial pressure, shock, tachycardia, change in the complex QRS, ventricular fibrillation, cardiac arrest), neurotoxic effects, including agitation, confusion, convulsions, disorientation, drowsiness, stupor or coma; mydriasis, dry mouth, hyperpyrexia or hypothermia, muscle stiffness, vomiting, pulmonary edema, or respiratory depression.

    Treatment: symptomatic: to eliminate extrapyramidal disorders using antiparkinsonian drugs from the group of central m-holinoblokatorov, barbiturates or diphenhydramine. If it is necessary to prescribe stimulants, it is better to use amphetamine, dextroamphetamine or caffeine. It should avoid the appointment of stimulants that can cause seizures (picrotoxin, pentylenetetrazole). With the development of arterial hypotension, norepinephrine and phenylephrine. The use of other vasopressor drugs (including epinephrine) is not recommended, t. metabolites of triftazine can change their effect, which leads to an even greater decrease in blood pressure. Control of cardiovascular function for at least 5 days, functions of the central nervous system, respiration, body temperature measurement, psychiatrist consultation. Dialysis is ineffective.Do not induce vomiting to empty the stomach.

    Interaction:

    Weaken the effects of levodopa and phenamine derivatives, the latter reduce the antipsychotic activity of trifluoperazine. Strengthens the action of ethanol and other drugs that depress the central nervous system (general anesthetics, narcotic analgesics, opioids, barbiturates), as well as atropine.

    At simultaneous reception with antiepileptic medicines (including barbiturates) trifluoperazine reduces their effect (reduces the epileptic threshold).

    Reduces the effect of anorectic drugs (with the exception of fenfluramine).

    Reduces the effectiveness of the emetic action of apomorphine, strengthens its inhibitory effect on the central nervous system.

    Increases the concentration in the plasma of prolactin and prevents the action of bromocriptine. When combined with tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, lengthening and strengthening of sedative and anticholinergic effects are possible, with thiazide diuretics - the appearance of electrolyte imbalance,with lithium preparations - reduced absorption in the gastrointestinal tract, an increase in the rate of lithium excretion by the kidneys, an increase in the severity of extrapyramidal disorders, early signs of lithium intoxication (nausea and vomiting) may be masked by the antiemetic effect of trifluoperazine.

    In combination with beta-blockers enhances the hypotensive effect, it increases the risk of irreversible retinopathy, arrhythmias and tardive dyskinesia. Reduces the effect of indirect anticoagulants.

    The use of alpha and beta adrenostimulators (epinephrine) and sympathomimetics (ephedrine) can lead to a paradoxical decrease in blood pressure. Amitriptyline, amantadine, H1-histamine receptor blockers and other drugs with m-cholinoblocking effect increase m-cholinoblocking activity. Aluminum and magnesium-containing antacid drugs or anti-diarrhea adsorbents reduce absorption.

    Antithyroid drugs increase the risk of agranulocytosis. Probucol, astemizole, cisapride, disopyramide, erythromycin, pimozide, procainamide, quinidine promote additional lengthening of the interval Q-T, which increases the risk of developing ventricular tachycardia.

    With the simultaneous use of phenothiazides with propranolol, an increase in the concentration of both drugs is noted.

    Special instructions:

    To correct extrapyramidal disorders, antiparkinsonian drugs are used - trihexyphenidyl and others; dyskinesias are cut by subcutaneous injection of 2 ml of a 20% solution of caffeine and 1 ml of a 0.1% solution of atropine).

    The drug, having a cardiotoxic effect, can cause arterial hypotension, worsening of cardiac hemodynamics (pulmonary edema, ventricular fibrillation and as a consequence of sudden sudden death) in elderly patients with psychoses.

    In elderly patients, the development of irreversible dyskinesia. When signs of late dyskinesia, neuroleptic malignant syndrome, treatment should be discontinued.

    Against the background of therapy with phenothiazines, it is possible to receive false positive tests for phenylketonuria.

    The administration of phenothiazines should be discontinued no less than 48 hours before the proposed myelography (resumption is possible after 24 hours).

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

    During treatment, it is not recommended to drive vehicles, as well as engage in activities that require speed of psychomotor reactions and precise movements.

    Form release / dosage:

    Tablets coated with a coating, 5 mg or 10 mg.

    Packaging:

    10 tablets coated with a shell in a contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

    For 50 or 100 tablets covered with a shell in a jar glass, ukuporennuyu plastic lid or a jar of polymer.

    Each jar or 5 contour mesh packages together with the instruction for use is placed in a pack of cardboard.
    Storage conditions:

    In a dry, dark place at a temperature of 5 to 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001406 / 02
    Date of registration:22.05.2008
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.10.2015
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