Terialgen® (Teraligen®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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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: & nbspsolution for infusion and intramuscular injection
    Composition:

    1 ml of the solution contains:

    active substance: alimamazine tartrate in terms of dry matter - 5.0 mg;

    Excipients: ascorbic acid 1.0 mg, sodium sulfite 0.5 mg, water for injection up to 1 ml.

    Description:

    Colorless or slightly colored, clear or slightly opalescent liquid.

    Pharmacotherapeutic group:Anxiolytic agent, sedative, hypnotics
    ATX: & nbsp

    R.06.A.D.   Phenothiazine derivatives

    R.06.A.D.01   Alimemazine

    Pharmacodynamics:

    Is a phenothiazine derivative. In connection with antihistaminic activity alimamazine apply for allergic diseases, especially the respiratory tract, and with skin itching. Alimemazine is more active in antihistamine and sedative action than diprazine. Has antiemetic and antitussive activity. Alimemazine also acts as a mild sedative and anti-anxiety agent, has a positive effect on shestopathy, obsession and phobia.

    It is used for psychosomatic manifestations, developing due to neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system.

    The sedative effect contributes to the normalization of sleep in patients in this category.

    The antipruritic effect is due to the effect on the histamine receptors of the first type.

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

    Antiemetic and vegetative stabilizing effect is due to blockade of dopamine D2receptors of the trigger zone of the vomiting center.

    Pharmacokinetics:

    Quickly and fully absorbed in any way of administration. The action of alimamazine begins 15-20 minutes after administration and lasts 6-8 hours. The connection with plasma proteins is 20-30%. Metabolised in the liver. It is excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide).

    Indications:

    Symptomatic treatment of allergic conditions of various origins (rhinitis, conjunctivitis, itching, hives, angioedema).

    As a sedative and anxiolytic remedy for relief of symptoms with neuroticand psycho-vegetative disorders.

    As a sedative for premedication and in the postoperative period.

    In the complex therapy of alcohol withdrawal syndrome.

    Contraindications:

    Hypersensitivity to phenothiazines or to any component of the drug.

    Deep central nervous system depression and coma.

    Simultaneous treatment with monoamine oxidase inhibitors (MAO); the drug can be used no earlier than 14 days after discontinuation of treatment with MAO inhibitors.

    Alcohol intoxication, acute intoxication sleeping pills and narcotic analgesics.

    Glaucoma.

    Sleep apnea syndrome.

    Episodic manifestations of vomiting in children of unknown origin.

    Pregnancy.

    Breastfeeding period.

    Carefully:

    Carefully should be used in alcoholism, if there is an indication in the anamnesis 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:

    Apply intramuscularly, with caution, to avoid accidental subcutaneous injection, which can lead to local necrosis at the site of injection.

    Dosage is determined by the doctor individually depending on the nature of the disease.

    The maximum daily dose is 200 mg.

    Symptomatic treatment of allergic conditions - 25 mg 1-2 times a day.

    In acute cases and in psychiatric practice adults are prescribed up to 100-200 mg / day.

    As a sedative during the period of premedication - 25-50 mg for 1-2 hours before the operation.

    In the complex therapy of alcohol withdrawal syndrome - 50 mg 1-2 times a day.
    Side effects:

    Side effects are extremely rare and are not very pronounced.

    From the nervous system: drowsiness, lethargy, fast fatigue (occur mainly in the first days of admission and rarely require drug withdrawal),a paradoxical reaction (anxiety, agitation, nightmarish dreams, irritability); confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor).

    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 gastrointestinal tract, constipation, decreased appetite.

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

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

    Other: allergic reactions, oppression of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitivity.

    Overdose:

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

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

    Alimamazin enhances the effects of narcotic analgesics, hypnotics,anxiolytic (tranquilizers) and antipsychotic (neuroleptics) drugs (LS), as well as drugs for general anesthesia, m-holinoblokatorov and antihypertensive drugs (requires dose adjustment).

    Tricyclic antidepressants and anticholinergic drugs increase the m-cholinoblocking activity of alimamazine.

    With the simultaneous use of alimamazine with ethanol, the inhibition of the central nervous system 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).

    With the joint use of alimamazine with beta-adrenoblokatorami possible a significant reduction in blood pressure, arrhythmia.

    Alimamazin weakens the effect of bromocriptine. With the simultaneous use in nursing mothers may increase the concentration of prolactin in the blood serum.

    With the simultaneous use of alimamazine and MAO 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.

    Joint use of phenothiazine derivatives (including alimamazine) with hepatotoxic drugs may increase manifestations of hepatotoxicity of the latter.

    Special instructions:

    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 skin scarification test results for allergens, the drug should be discontinued 72 hours before allergological testing.

    It should be borne in mind that the solution for injection contains sulfites, which can enhance anaphylactic-type reactions.

    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 should not engage in activities that require increased concentration and speed of psychomotor reactions (driving and other vehicles,work with moving mechanisms, the work of the dispatcher and the operator).
    Form release / dosage:

    Solution for infusion and intramuscular injection, 5 mg / ml.

    Packaging:

    When manufactured at OAO Novosibkhimpharm

    5 ml per ampoule of light-protective glass.

    For 10 ampoules together with instructions for use and a knife for opening ampoules or a scarifier ampoule in a box of cardboard, pasted with a label-parcel postal paper for offset printing.

    By 5 or 10 ampoules per contour cell packaging of polyvinyl chloride film or polyethylene terephthalate and aluminum foil or paper with polyethylene coating or without foil, or without paper.

    For 1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier ampullum in a pack of cardboard.

    When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

    When produced in the Federal State Educational Establishment of the Russian Federation, the Ministry of Health of the Russian Federation

    5 ml per ampoule of light-protective glass.

    5 ampoules per contour cell packaging made of polyvinyl chloride film.

    For 1 or 2 contour packs with instructions for use in a pack of cardboard.

    Storage conditions:

    In 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 expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004019
    Date of registration:12.12.2016
    Expiration Date:12.12.2021
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Information update date: & nbsp19.01.2017
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