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

    Active substance:

    Chloropyramine hydrochloride

    (in terms of 100% substance) - 20, .0 mg

    Excipient:

    water for injection up to 1.0 ml.

    Description:Transparent colorless or with a slightly yellowish or greenish tinge liquid with a 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-histamine receptors antihistamine and m-cholinoblocking action, has antiemetic effect, moderate spasmolytic and peripheral cholinoblocking activity.

    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 (angioedema) as an adjuvant.

    Contraindications:

    - Hypersensitivity to the components of the drug,

    - an acute attack of bronchial asthma,

    - newborn children (full and premature),

    - Pregnancy,

    - the period of breastfeeding.

    Carefully:

    Closed-angle glaucoma, urinary retention, prostatic hyperplasia, liver and / or kidney dysfunction, cardiovascular diseases, elderly patients.

    Pregnancy and lactation:

    There have been no adequate, with proper control, studies of the use of antihistamines in pregnant women. In accordance with this, apply chloropyramamine during pregnancy is contraindicated. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved.

    Dosing and Administration:

    Intravenous or intramuscular.

    Intravenously applied only in acute severe cases under the supervision of a doctor!

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

    For children: recommended initial doses:

    children aged from 1 to 12 months-0.25 ml (1/4 ampoules) intramuscularly; children aged 1 to 6 years - 0.5 ml (1/2 ampoules) intramuscularly; Children aged 6 to 14 years - 0.5-1 ml (1 / 2-1 ampoule) intramuscularly.

    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, depleted patients: The use of chloro-pyramine requires a special prudence, because In these patients, antihistamines often cause side effects (dizziness, drowsiness).

    Patients with impaired hepatic function: it may be necessary to reduce the dose due to a decrease in the metabolism of chloropyramine in liver diseases.

    Patients with impaired renal function: may need to change the regimen of the drug and reduce the dose due to the fact that chloropyramamine and its metabolites are mainly secreted through the kidneys.

    Side effects:

    Side effects, as a rule, occur extremely rarely, are temporary, pass after the drug is discontinued.

    From the side of the blood and lymphatic system: very rarely: leukopenia, agranulocytosis, hemolytic anemia and other changes in blood composition.

    Co side of the immune system: allergic reactions.

    From the central nervous system: drowsiness, fatigue, dizziness, nervous excitement, tremor, headache, euphoria, convulsions, encephalopathy.

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

    From the cardiovascular system: lowering blood pressure, tachycardia, arrhythmia. It was not always possible to establish a direct relationship between these side effects and drug intake.

    From the gastrointestinal tract: discomfort in the abdomen, dry mouth, nausea, vomiting, diarrhea, constipation, loss or increase in appetite, pain in the upper abdomen.

    From the skin and subcutaneous tissues: photosensitization.

    From the side of the musculoskeletal and connective tissue: muscle weakness.

    From the urinary system: rarely - difficulty urinating, urinary retention.

    If any of the above effects occur, you should stop taking the drug and immediately consult a doctor.

    Overdose:

    Symptoms: hallucinations, anxiety, ataxia, movement coordination disorders, athetosis, convulsions. In young children, excitement, anxiety, dry mouth, fixed dilated pupils, redness of the face, sinus tachycardia, urinary retention, fever, coma.In adults, fever and redness of the face are not constant, 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 not known.

    Interaction:

    The drug enhances the effect of drugs: barbiturates, M-holinoblokatorov, opioid analgesics. Monoamine oxidase (MAO) inhibitors can enhance and prolong the anticholinergic action of chloropyramine. When combined with ototoxic drugs chloropyramamine can mask the early signs of ototoxicity. Antihistamines can distort the results of cutaneous allergological tests, therefore, several days before the scheduled test, medication of this type should be discontinued.

    Special instructions:

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

    Long-term use of antihistamines may lead to violations of the blood system and hematopoiesis (leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia).If, during prolonged use, there is an unexplained increase in body temperature, laryngitis, pale skin, jaundice, the formation of ulcers in the mouth, the appearance of hematomas, unusual and prolonged bleeding, it is necessary to conduct a clinical blood test with the definition of the number of uniform elements. If the results of the analysis indicate a change in the blood formula, the drug is discontinued.

    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 a liver or kidney disease. Taking the drug at night can increase the symptoms of reflux esophagitis. Chloropyramine can strengthen the effect of alcohol on the central nervous system, and therefore during the drug should avoid the use of alcoholic beverages.

    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, it is prohibited to perform works requiring increased concentration of attention and speed of psychomotor reactions (management of vehicles and mechanisms). After that, the degree of restriction on driving and the work with the mechanisms of the doctor should be determined for each patient individually.

    Form release / dosage:

    A solution for intravenous and intramuscular administration of 20 mg / ml.

    Packaging:

    By 1 ml in ampoules.

    5 ampoules in the outline of the cell.

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

    In each pack you put the instruction for the medical use of the drug, the ampoule scarifier (when packing ampoules with a ring of fracture, dots and notches the ampoule scaper does not invest).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Shelf life:

    4 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004620
    Date of registration:26.12.2017
    Expiration Date:26.12.2022
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.01.2018
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