Propazin (Propazinum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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  • Propazin
    pills inwards 
    TATHIMFARMPREPARATY, JSC     Russia
    • Dosage form: & nbspcoated tablets
    Composition:

    1 tablet, coated, contains:

    active substance: promazine 25.0 mg;

    Excipients: lactose (milk sugar) 37.0 mg, potato starch 52.62 mg, stearic acid 2.90 mg, sucrose (sugar) 95.50 mg, dextrose monohydrate (glucose monohydrate) 33.10 mg, talc 4.80 mg, indigocarmine 0.08 mg.

    Description:

    The tablets covered with a cover, blue color with impregnations and marble. The heterogeneity of the surface coloring of the tablets is allowed. Two layers are visible on the cross-section.

    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.A   The phenothiazine derivatives with an aliphatic structure

    N.05.A.A.03   Promazin

    Pharmacodynamics:

    Promazine is a drug from a group of aliphatic derivatives of phenothiazine. The chemical structure and spectrum of action of promazine is similar to aminazine (chlorpromazine), but the drug is less active and less toxic.

    The mechanism of antipsychotic action promazina is associated with the blocking of postsynaptic mesolimbic dopaminergic receptors in the brain.

    The strength of the antipsychotic and sedative effect is inferior to aminazine, reduces motor activity, has antiemetic, hypotensive and hypothermic effects.Peripheral cholino- and adrenoblocking action is similar to that of aminazine; for anti-histamine action, the drug is superior to aminazine. It has less pronounced side effects (phenomena of akathisia, inhibition, depression, lethargy, apathy, extrapyramidal and somatovegetative disorders) than in aminazine.

    Increases the duration and intensity of sleeping pills, narcotic, analgesics, hypotensive, antihistamines and alcohol.

    Pharmacokinetics:Well absorbed after ingestion. Time to reach a maximum concentration of 2-4 hours. The connection with plasma proteins is 90%. Metabolized in the liver with the formation of inactive metabolites. It is excreted mainly by the kidneys.
    Indications:

    (Promazin apply for the same indications as aminazine, especially in cases of an easier flow of the disease, for maintenance therapy, as well as for weakened patients and senile persons).

    Acute and chronic psychoses accompanied by psychomotor agitation, hallucinatory and delusional disorders, manic conditions, agitated depression,psychotic disorders of any etiology; with other mental illnesses (neuroses, psychopathies, reactive states) accompanied by excitement, fear, insomnia, stress, impulsive attacks, to alleviate withdrawal symptoms in narcological practice.

    Promazin can be used in combination with other psychotropic (antidepressants, butyrofenone derivatives, etc.).

    As an antiemetic for vomiting of various etiologies.

    Contraindications:

    - Increased individual sensitivity;

    - oppression of the central nervous system and comatose states of any etiology;

    - brain trauma;

    - diseases of the liver, kidneys and hematopoietic organs with impaired functions;

    - progressive systemic diseases of the brain and spinal cord;

    - Stomach ulcer and duodenal ulcer in the period of exacerbation;

    - heart disease in the stage of decompensation (heart defects, myocardial dystrophy, rheumatic carditis, etc.), severe arterial hypotension, diseases accompanied by a risk of thromboembolic complications;

    - bronchoectatic disease in the stage of decompensation;

    - angle-closure glaucoma (risk of increased intraocular pressure);

    - hyperplasia of the prostate;

    - myxedema;

    - intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption;

    - pregnancy, the period of breastfeeding;

    - children under 12 years.

    Carefully:

    - Parkinson's disease;

    - active alcoholism (risk of hepatotoxic effects);

    - mammary cancer;

    - epilepsy;

    - Chronic diseases accompanied by breathing disorders (especially in children over 12 years old);

    - Reye's syndrome;

    - cachexia;

    - elderly age.

    Dosing and Administration:

    Promazin is taken orally (after eating).

    Inside appoint 25-100 mg 2-4 times a day, if necessary, the dose is gradually increased to 500-1000 mg / day. For maintenance therapy appoint 50-150 mg 1-2 times a day.

    Children 12 years and older: inside 25 mg every 4-6 hours, if necessary, and taking into account the tolerability dose adjusted.

    Older people, poor or weak patients usually a smaller initial dose is required, if necessary, and taking into account the tolerance, it is gradually increased.

    Side effects:

    Promazine is tolerated better than aminazine, and less often it causes side effects, but with prolonged use of the drug are possible: extrapyramidal disorders (dyskinesia, akinetorhidic phenomena, akathisia, hyperkinesia, tremor,vegetative disorders), in single cases - convulsions. As proof-readers apply antiparkinsonian means.

    Dyskinesia (paroxysmal cramps in the muscles of the neck, tongue, mouth cavity, oculogic crises) are stopped by caffeine sodium (2 ml of 20% solution subcutaneously) and atropine (1 ml 0.1% solution subcutaneously). Perhaps the development of tardive dyskinesia, less often - malignant neuroleptic syndrome.

    At the beginning of treatment, drowsiness, dizziness, dry mouth, nasal congestion, anorexia, accommodation disorders (blurred vision), mild orthostatic hypotension, tachycardia, sleep disorders, difficulty urinating, nausea, vomiting, gastralgia, constipation may occur.

    Rare complications include pigmentary retinopathy, cholestatic jaundice, cardiac arrhythmias, leukopenia, agranulocytosis, allergic reactions, angioedema, menstrual irregularities, decreased sexual potency, galactorrhea, priapism, melanosis, thermoregulation, weight gain, photosensitization of the skin (patients should not therefore be exposed to UV radiation).

    With the use of promazine, there may appear phenomena of psychic indifference, a belated reaction to external stimuli and other changes in the psyche.

    Overdose:

    Symptoms: Areflexia or hyperreflexia, blurred vision, cardiotoxicity (arrhythmia, heart failure, lowering blood pressure, shock, tachycardia, changes in tooth QRS, Ventricular fibrillation, cardiac arrest), neurotoxic effects, including agitation, confusion, convulsions, disorientation, lethargy, stupor or coma, mydriasis, dry mouth, hyperpyrexia or hypothermia, muscle rigidity, vomiting, pulmonary edema and respiratory depression.

    Treatment: gastric lavage, the appointment of activated charcoal (avoiding the induction of vomiting, as impaired consciousness and dystonic reactions from the muscles of the neck and head due to overdose can lead to aspiration of vomit).

    Symptomatic treatment: with arrhythmia - in / in phenytoin 9-11 mg / kg, in heart failure - cardiac glycosides, with marked reduction of blood pressure - in / in a liquid or vasopressor agents such as norepinephrine, phenylephrine (avoid the appointment of alpha and beta-adrenomimetics, such as epinephrine), with convulsions - diazepam, with parkinsonism - diphenyltropine.
    Control of cardiovascular function for at least 5 days, functions of the central nervous system, respiration, measurement of body temperature, consultation of a psychiatrist.
    Dialysis is ineffective.
    Interaction:

    - With the simultaneous use of promazine with other drugs that have a depressing effect on the central nervous system (narcosis drugs, narcotic analgesics, alcohol and drugs containing it, barbiturates, tranquilizers, etc.), it is possible to increase the depression of the central nervous system, as well as respiratory depression;

    - with tricyclic antidepressants, maprotiline or MAO inhibitors - an increased risk of malignant neuroleptic syndrome;

    - with anticonvulsants - it is possible to lower the convulsive threshold;

    - with drugs for the treatment of hyperthyroidism - increases the risk of agranulocytosis;

    - with other drugs that cause extrapyramidal reactions - it is possible to increase the frequency and severity of extrapyramidal disorders;

    - with antihypertensive medications - pronounced orthostatic hypotension is possible;

    - with ephedrine - possibly reducing the vasoconstrictive effect of ephedrine;

    - reduces the effectiveness of the emetic action of apomorphine, strengthens its inhibitory effect on the central nervous system;

    - reduces the effect of funds that reduce appetite (with the exception of fenfluramine);

    - simultaneous application with bromocriptine can increase the concentration in the blood plasma of prolactin and reduce its effect.

    In the treatment with promazine, epinephrine (adrenaline) should be avoided, since the effect of epinephrine may be distorted, which can lead to a drop in blood pressure.

    The antiparkinsonian action of levodopa is reduced due to the blocking of dopamine receptors.

    Promazin can suppress the action of amphetamine, clonidine, guanethidine.

    Promazin enhances the anticholinergic effects of other drugs, while the antipsychotic effect of the antipsychotic may decrease.

    With the simultaneous use of promazine with a prochlorperazine related to the chemical structure, a prolonged loss of consciousness may occur.

    It is necessary to avoid simultaneous application with adsorptive and antidiarrhoeic agents.

    Absorption promazina is disrupted with the simultaneous use of antacids, antiparkinsonian drugs, lithium preparations.

    Special instructions:

    During treatment with promazine, careful monitoring of the arterial pressure and pulse, regular examination of the function of the liver, kidneys, pictures of peripheral blood, examination of the oculist.

    The antiemetic effect of phenothiazines can mask vomiting associated with overdose of other drugs.

    During the treatment period, do not drink alcohol!

    Promazin can not be assigned during work to drivers of transport and other persons, whose profession is associated with speed and high accuracy of movement.

    Form release / dosage:

    Tablets coated with a coating, 25 mg.

    Packaging:

    10 tablets per contour cell pack.

    5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry, the 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 after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N003323 / 01
    Date of registration:10.06.2009
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspTATHIMFARM PREPARATIONS OJSC TATHIMFARM PREPARATIONS OJSC Russia
    Information update date: & nbsp04.09.2015
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