Active substanceAlimemazineAlimemazine
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  • Terialgen®
    pills inwards 
    VALENTA PHARM, PAO     Russia
  • Terialgen®
    solution w / m d / infusion 
    VALENTA PHARM, PAO     Russia
  • Terialgen® Valenta
    pills inwards 
    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbspfilm coated tablets
    Composition:

    One tablet contains:

    Active substance:

    Alimamazine tartrate - 5.0 mg or 10.0 mg;

    Excipients: lactose monohydrate 73.4 mg or 79.1 mg, microcrystalline cellulose 60.8 mg or 67.5 mg, pregelatinized starch 16.0 mg or 18.0 mg, silicon dioxide colloid (aerosil) 1.6 mg or 1.8 mg, croscarmellose sodium 1.6 mg or 1.8 mg, magnesium stearate 1.6 mg or 1.8 mg.

    Shell composition:

    for a dosage of 5 mg:

    Opadrai II 85F34655 - 5.0 mg: partially hydrolysed polyvinyl alcohol - 40,00 %, macrogol-3350 - 20.20%, talc - 14,80 %, titanium dioxide E 171 - 19.44%, carmine red dye E 120 - 4.50%, lacquer aluminum based on the dye sunset yellow E 110 - 1.05%, aluminum based on indigo carmine E 132-0.01 %;

    for a dosage of 10 mg:

    Opadrai II 85F34750 - 6.0 mg: partially hydrolysed polyvinyl alcohol - 40,00 %, macrogol-3350 - 20.20%, talc - 14,80 %, titanium dioxide E 171 - 21.79%, lacquer aluminum based on the dye red enchanting E 129 - 3.02%, iron oxide dye yellow E 172 - 0.15%, ferric oxide black oxide E 172-0.04% .

    Description:

    Round biconvex tablets,coated with pink color (for a dosage of 10 mg) or dark pink color with a risk (for a dosage of 5 mg); on the cross-section, two layers are visible: a pink coat (for a dosage of 10 mg) or a dark-colored color (for a dosage of 5 mg) and a white core.

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

    R.06.A.D.   Phenothiazine derivatives

    R.06.A.D.01   Alimemazine

    Pharmacodynamics:

    Antipsychotic drug (antipsychotic). - Has H1-histamine-blocking, antispasmodic, antiserotonergic, moderate alpha-adrenoblocking, antiemetic, hypnotic, sedative and antitussive.

    The antipsychotic effect is due to the blockade of dopamine D2-receptor mesolimbic and mesocortical system.

    Sedative action is due to blockade of adrenoreceptors of the reticular formation, brainstem.

    Antiemetic effect due to blockade of dopamine D2 receptors of the trigger zone of the vomiting center.

    Hypothermic effect is due to blockade of dopamine receptors of the hypothalamus.

    The beginning of the effect - after 15-20 minutes, the duration of the action - 6-8 hours.

    Has a low antipsychotic activity, therefore, in acute psychotic conditions is ineffective.

    Due to its good tolerability it is used in children's, adolescent and gerontological practice.

    Pharmacokinetics:

    When ingested quickly and completely absorbed from the gastrointestinal tract (GIT). The maximum concentration (Cma) in plasma is observed after 1-2 hours. The connection with plasma proteins is 20-30%, the half-life (T1 / 2) is 3.5-4 hours. It is excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide) 48 hours.

    Indications:

    As sedative (soothing), anxiolytic (anti-anxiety) and hypnotics:

    - dementia including dementia due to epilepsy) that occurs with manifestations of psychomotor agitation, anxiety affect (as part of combination therapy);

    - organic anxiety disorder (in the form of monotherapy or as part of combination therapy);

    - schizophrenia (with prevalence of neurosis-like disorders, as part of combination therapy);

    - mood disorders (affective disorders) - as part of a combination therapy;

    - generalized anxiety disorder (as part of combination therapy);

    - obsessive-compulsive disorder (as part of combination therapy);

    - response to severe stress and adaptation disorders (acute reaction to stress, post-traumatic stress disorder, unspecified response to severe stress, other reactions to severe stress) - as part of combination therapy;

    - dissociative (conversion) disorders (as part of combination therapy);

    - somatoform disorders (somatization disorder, undifferentiated, somatoform disorder, hypochondriacal disorder, somatoform dysfunction of the autonomic nervous system, stable somatoform pain disorder, unspecified somatoform disorder, other somatoform disorders) - in combination therapy with severe anxiety or with ineffective standard therapy;

    - unspecified disorder of the autonomic nervous system, other disorders of the autonomic nervous system (as part of combination therapy);

    - anorexia nervosa (as part of combination therapy);

    - emotionally unstable personality disorder (impulsive and borderline types) - as part of combination therapy;

    - hysterical personality disorder, anxious (evading, avoiding)frompersonality structure (as part of combination therapy);

    - persistent personality change after the experience of the disaster (as part of combination therapy);

    - hyperkinetic behavior disorder (as part of combination therapy);

    - behavioral disorder confined to the family (as part of combination therapy with ineffectiveness of standard therapy);

    - non-specialized behavior disorder (in the form of monotherapy or as part of a combination therapy.);

    - anxiety, arousal and other symptoms and signs related to the emotional state (as part of combination therapy);

    - other neurotic disorders (neurasthenia, unspecified neurotic disorder) - as part of combination therapy;

    - insomnia of inorganic etiology (as part of combination therapy with ineffectiveness of standard therapy);

    - emotional disorders, the beginning of which is specific for childhood (phobic anxiety disorder in childhood, social anxiety disorder in childhood, frustration due to sibling (with siblings) rivalry, unspecified emotional disorder in childhood, other emotional disorders in childhood) - as part of combination therapy.

    As an antiallergic agent:

    - itching regardless of place and etiology (itching of the anus, itching of the vulva, unspecified anogenital itching, pruritus with photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings with non-venomous insects or other non-venomous arthropods, chicken pox, measles, Hodgkin's disease, diabetes mellitus, shingles) in the form of monotherapy or as part of a combination therapy;

    - asthma, hay fever, whooping cough (as part of complex therapy as an antiallergic agent for cough relief, dyspnea and attacks of suffocation);

    - unspecified allergy as a monotherapy or as part of a combination therapy).

    Contraindications:

    - hypersensitivity to the components of the drug;

    - lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

    - angle-closure glaucoma;

    - hyperplasia of the prostate;

    - severe hepatic and / or renal insufficiency;

    - Parkinsonism;

    - myasthenia gravis;

    - Reye's syndrome;

    - simultaneous use of monoamine oxidase inhibitors (MAO);

    - pregnancy;

    - lactation period;

    - children under 7 years.

    Carefully:

    With caution should be used in alcoholism, if there is an indication in the history of complications with the use of preparations phenothiazine series; with obstruction of the neck of the bladder; predisposition to urinary retention; with epilepsy; open-angle glaucoma; jaundice; oppression of bone marrow function; arterial hypotension.

    Pregnancy and lactation:Contraindicated in pregnancy and lactation (breastfeeding). If pregnancy occurs during the treatment period, the drug should be discontinued. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:

    Inside, not liquid. The effect of the drug is dose-dependent, doses are selected depending on the purpose of therapy.The daily dose is divided into 3-4 doses.

    Adults: to achieve a sedative and anxiolytic effect - 5-10 mg / day; to achieve a hypnotic effect - 60-80 mg / day, to achieve antipsychotic actions - 200-400 mg / day. For symptomatic treatment of allergic reactions appoint 10-40 mg / day. The highest dose for adults is 500 mg / day, for the elderly (over 60 years) - 200 mg / day.

    Children appoint 7.5 to 25 mg / day depending on age: the average therapeutic dose for children from 7 to 14 years is 5 mg / day (maximum daily dose is 15 mg / day), for children from 15 to 18 years -10 mg / day (the maximum daily dose is 50 mg / day).

    Side effects:

    Usually the drug is tolerated well by patients.

    From the nervous system: drowsiness, lethargy, fast fatigue (arise mainly during the first days of admission and rarely require drug withdrawal), a paradoxical reaction (anxiety, agitation, nightmares, irritability); confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor); more frequent sleep apnea, increased convulsive activity (in children).

    From the sense organs: blurred vision (paresis of accommodation), noise or ringing in the ears.

    From the cardiovascular system: dizziness, lowering of blood pressure (BP), tachycardia.

    From the digestive system: dryness of the oral mucosa, atony of the digestive tract, constipation, decreased appetite.

    From the respiratory system: dryness in the nose, pharynx, increase in the viscosity of bronchial secretions.

    From the urinary system: atony of the urinary bladder, urinary retention.

    Other: allergic reactions, inhibition of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitization.

    Overdose:

    Symptoms: increased manifestations of the described side effects, except for allergic reactions.

    Treatment: cancellation of the drug, gastric lavage, the appointment of activated charcoal, symptomatic therapy.

    Interaction:

    Alimamazin enhances the effects of narcotic analgesics, hypnotics, anxiolytic (tranquilizers) and antipsychotic drugs (neuroleptics), as well as drugs for general anesthesia, m-holinoblokatorov and hypotensive drugs (requires dose adjustment). Tricyclic antidepressants and anticholinergic drugs increase m-cholinoblocking activityalimamazine. With the simultaneous use of alimamazine with ethanol, an increase in CNS depression is possible.

    Alimamazine weakens the action of derivatives of phenamine, m-cholinomimetics, ephedrine, guanethidine, levodopa, dopamine.

    With the joint use of alimamazine with antiepileptic drugs and barbiturates, the threshold of convulsive activity decreases (correction of doses is required).

    When combined alimamazine and beta-adrenoblockers mutually increase the concentration in the plasma (there may be a marked decrease in blood pressure, arrhythmia).

    Alimamazine weakens the effect of bromocriptine and increases the concentration of prolactin in the blood serum.

    With the simultaneous use of alimamazine and monoamine oxidase inhibitors (simultaneous use is not recommended) and alimamazine and phenothiazine derivatives, the risk of arterial hypotension and extrapyramidal disorders is increased.

    With the simultaneous use of alimamazine with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

    Hepatotoxic drugs increase the manifestation of alimamazin hepatotoxicity.

    Antacids, Activated carbon and holestiramin with simultaneous intake reduce the absorption of neuroleptics (if necessary, a joint dose with alimamazinom these drugs should be used 1 hour before or 2 hours after it is taken).

    Special instructions:

    With long-term treatment should be systematically to conduct a general blood test, evaluate liver function.

    Alimamazine can mask the ototoxic effect (tinnitus, dizziness) of the drugs used together.

    Alimamazine increases the body's need for riboflavin.

    To prevent distortion of the results of skin scarification tests for allergens, the drug should be discontinued 72 hours before allergy testing.

    During treatment, false positive results are possible for pregnancy.

    During the treatment should not drink alcohol.
    Effect on the ability to drive transp. cf. and fur:Against the background of drug treatment, you should not engage in activities that require increased concentration and speed of psychomotor reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work).
    Form release / dosage:Tablets, film-coated, 5 mg and 10 mg.
    Packaging:

    For 10 or 25 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    1 or 2 contourcell packs of 25 tablets for dosages of 5 mg or 10 mg, 3 or 5 contour cell packs of 10 tablets for a dosage of 5 mg, 3 contiguous cell packs of 10 tablets for a dosage of 10 mg together with the instruction for use are placed in a pack.

    Storage conditions:

    AT protected from light 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:LP-000642
    Date of registration:28.09.2011
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.08.2015
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