Active substanceChloropyramineChloropyramine
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Active substance: chloropyramine hydrochloride in terms of 100% of the substance - 20 mg.

    Excipients: water for injection - up to 1 ml.

    Description:Transparent, colorless or yellowish liquid with a weak characteristic odor.
    Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    D.04.A.A.09   Chloropyramine

    R.06.A. C.03   Chloropyramine

    Pharmacodynamics:

    Chloropyramine - a chlorinated analogue of tripelenamine (pyribenzamine) is a classic antihistamine drug belonging to the group of ethylenediaminic antihistamines.

    Blocker H1-gistaminovyh receptors, has antihistamine and mhholinoblokiruyuschee effect, has antiemetic effect, moderate spasmolytic and peripheral cholinoblocking

    Pharmacokinetics:

    It is well distributed in the body, including the central nervous system (CNS). Intensively metabolized in the liver. It is excreted mainly by the kidneys. In children, excretion occurs faster than in adult patients.

    Indications:

    Hives, serum sickness, seasonal and year-round allergic rhinitis, conjunctivitis, contact dermatitis, itching, acute and chronic eczema, atopic dermatitis, food and drug allergies, allergic reactions to insect bites.

    Angioedema (as an adjuvant).
    Contraindications:

    - Hypersensitivity to the components of the drug,

    - an acute attack of bronchial asthma,

    - Newborn children (full and premature),

    - pregnancy,

    - lactation period.

    Carefully:

    Closed-angle glaucoma, urinary retention, prostatic hyperplasia, impaired liver and / or kidney function, cardiovascular disease, elderly patients.

    Pregnancy and lactation:

    During pregnancy and during breastfeeding, the safety and efficacy of the drug are not established.

    Pregnancy and the period of breastfeeding are contraindications to the use of the drug.

    Dosing and Administration:

    Intravenously applied only in acute severe cases under control doctor!

    Adults: the recommended daily dose is 1-2 ml (1-2 ampoules) intramuscularly.

    Children: recommended initial doses:

    Children aged from 1 to 12 months: 0.25 ml (1/4 ampoule) in / m;

    at the age from 1 to 6 years: 0.5 ml (1/2 ampoule) w / m;

    at the age from 6 to 14 years: (0.5-1 ml) 1 / 2-1 ampoule IM.

    The dose can be carefully increased depending on the patient's response and the observed side effects. However, the dose should never exceed 2 mg / kg of body weight. In severe allergy, treatment should begin with a cautious slow intravenous injection, then continue intramuscular injection or taking the drug inside.

    Special patient groups:

    Elderly, emaciated patients: drug administration Chloropyramine requires special care, because In these patients, antihistamines often cause side effects (dizziness, drowsiness).

    Patients with impaired hepatic function: a dose reduction may be required due to a decrease in the metabolism of the active component of the drug in liver diseases.

    Patients with impaired renal function: it may be necessary to change the regimen of the drug and reduce the dose due to the fact that the active component is mainly released through the kidneys.

    Side effects:

    From the central nervous system (CNS): drowsiness, weakness, fatigue, dizziness, headache, nervous excitement, tremor, euphoria, movement coordination disorders, convulsions, ataxia, encephalopathy, myopathy.

    On the part of the organs of the gastrointestinal tract: belly, pain in the upper abdomen, dryness of the oral mucosa, nausea, vomiting, diarrhea, constipation, loss or increased appetite.

    From the cardiovascular system: decrease in arterial pressure, tachycardia, arrhythmia.

    From the side of the organ of vision: blurred vision, glaucoma, increased intraocular pressure.

    From the side of hematopoiesis: leukopenia, agranulocytosis, hemolytic anemia and other pathological changes in the cellular composition of the blood.

    Other: difficulty urinating, urinary retention, muscle weakness, photosensitivity, allergic reactions.

    If any of the above side effects occur, you must stop taking the medication and seek medical advice immediately.
    Overdose:

    Symptoms: hallucinations, anxiety, ataxia, movement coordination disorders, athetosis, convulsions.

    In young children: agitation, anxiety, dryness of the oral mucosa, fixed dilated pupils, facial skin hyperemia, sinus tachycardia, urinary retention, fever, coma.

    In adults, fever and hyperemia of the skin is observed intermittently, after a period of excitement followed by convulsions and post-convulsive depression, coma.

    Treatment: symptomatic therapy. It is necessary to control the parameters of blood pressure and respiration. The specific antidote is unknown.
    Interaction:

    Chloropyramine enhances the effect of drugs for general anesthesia, hypnotics, sedatives, tranquilizers, analgesics (including opioids), local anesthetics, atropine, sympatholytic drugs, barbiturates, M-holinoblokatorov.

    MAO inhibitors can enhance and prolong the anticholinergic action of chloropyramine.

    Tricyclic antidepressants enhance m-cholinoblocking and inhibitory effect on the central nervous system. Caffeine reduces the inhibitory effect on the central nervous system.

    Simultaneous use with ethanol is not recommended (risk of severe CNS depression).

    When combined with ototoxic drugs chloropyramamine can mask the early signs of ototoxicity.

    Special instructions:

    Diseases of the liver and kidneys may require a change (decrease) in the dose of the drug, in connection with which the patient should inform the doctor about the presence of his liver disease and whether the kidneys.

    Taking the drug at night can increase the symptoms of reflux esophagitis.

    The simultaneous use of ethanol (alcoholic beverages) is inadmissible.

    Long-term use of antihistamines may lead to violations of hematopoiesis (leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia).If an unexplained increase in body temperature occurs during long-term use of the drug, laryngitis, pale skin, jaundice, ulceration in the mouth, the appearance of hematomas, unusual and prolonged bleeding, it is necessary to perform an analysis to determine the number of blood elements. If the results of the analysis indicate a change in the blood formula, the drug is stopped.

    Antihistamines can interfere with the reaction when setting skin allergological samples, therefore, several days before the planned test, taking this medication should be stopped.

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

    The drug, especially in the initial period of treatment, can cause drowsiness, fatigue and dizziness. Therefore, in the initial period, the duration of which is determined individually, driving is prohibited vehicles or work related from increased risk of accidents. After this, the degree of restriction on atThe doctor must determine the form of transport and work with the mechanisms individually for each patient.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 20 mg / ml.

    Packaging:

    1 ml of the drug in ampoules with a capacity of 2 ml.

    Each label is labeled with label or writing paper, or self-adhesive, or the text of the marking is applied to the ampoule by gravure printing using a fast-fixing ink.

    5 ampoules are placed in a contiguous cell pack of a polyvinylchloride film without coating.

    1 or 2 contour squares are placed in a pack of cardboard.

    10 ampoules are placed in a box of cardboard for consumer containers and with a loose leaf of paper paste.

    The box is pasted with a label-parcel of paper label or coated, or offset.

    In each pack or box, put the instructions for use and the ampoule scaler.

    When using ampoules with an incision, a ring of fracture or a break point, the ampoule scaper is not inserted.

    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:LP-004122
    Date of registration:08.02.2017
    Expiration Date:08.02.2022
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.03.2017
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