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 mg;

    Excipients: water for injection - up to 1 ml.

    Description:Transparent colorless or slightly yellowish or greenish 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 is a blocker of H1-receptors. The chemical structure refers to the derivatives of ethylenediamine. Chloropyramine selectively inhibits histamine H1 receptors and reduces the permeability of capillaries. Prevents development and facilitates the course of allergic reactions. Has a sedative and pronounced antipruritic effect. Has moderate peripheral anticholinergic and spasmolytic activity and antiemetic effect.

    Pharmacokinetics:

    Suction: The concentration in the blood reaches a maximum within 2 hours.

    Therapeutic concentration persists for 4-6 hours.

    Distribution: Evenly distributed in the body, penetrates through blood-brain barrier. The association of chloropyramine with plasma proteins is 7.9%. The binding peak was noted at pH 6.8-7.4.

    Excretion: metabolized in the liver, is excreted mainly through the kidneys with urine in the form of metabolites. The excretion of chloropyramine in children can occur faster than in adults.

    Indications:

    Hives, seasonal and year-round allergic rhinitis, conjunctivitis, serum sickness, drug and food allergy, acute and chronic eczema, contact dermatitis, itching, atopic dermatitis.

    Angioedema (angioedema) as an adjuvant.

    Allergic reactions to insect bites.

    Contraindications:

    Individual hypersensitivity to chloropyramine and other components of the drug. Newborn children (full and premature). Acute attack of bronchial asthma. Pregnancy and the period of breastfeeding.

    Carefully:

    Closed-angle glaucoma, urinary retention, prostatic hyperplasia, liver and / or kidney dysfunction, cardiovascular disease, 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, take 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:

    Intramuscularly or intravenously. Intravenously applied only in severe cases under the supervision of a doctor!

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

    Children: recommended initial doses: children aged 1 to 12 months - 0.25 ml (1/4 ampoules) IM; children aged 1 to 6 years - 0.5 ml (1/2 ampoule) in / m; children aged 6 to 14 years (0.5-1 ml) 1/2-1 ampoule in / m. 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 be started with cautious slow intravenous injection, then continue intramuscular injection or taking the drug inside.

    Special patient groups

    Elderly and debilitated patients: the use of chloropyramine requires a special prudence, because these patients are more likely to experience dizziness and drowsiness.

    Patients with impaired liver function: a dose reduction may be required due to a decrease in the metabolism of chloropyramine.

    Patients with impaired renal function; chloropyramamine and its metabolites are mainly secreted through the kidneys, a dose reduction may be required.

    Side effects:

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

    On the part of the digestive system: discomfort in the abdomen, dry mouth, nausea, vomiting, diarrhea, constipation, loss or increase in appetite, pain in the upper abdomen.

    From the urinary system: rarely - difficulty urinating. Retention of urine.

    From the cardiovascular system: lowering blood pressure, tachycardia, arrhythmia. It was not always established a direct relationship of these side effects with the drug.

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

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

    From the immune system: allergic reactions.

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

    From the skin and subcutaneous tissues: photosensitization.

    Overdose:

    Symptoms: hallucinations, anxiety, ataxia, impaired coordination of movements, 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 unknown.

    Interaction:

    The drug enhances the effect of drugs: barbiturates, m-holinoblokatorov, opioid analgesics. 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 signs of ototoxicity. 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 enhance symptoms of reflux esophagitis. Chloropyramine can enhance the effect of alcohol on the central nervous system, and therefore during the administration of the drug chloropyramamine should avoid the use of alcoholic beverages. 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 blood test results indicate a change in the blood formula, the drug is 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, it is prohibited to drive vehicles or perform work associated with an increased risk of accidents.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:

    1 ml per ampoule of neutral glass.

    For 10 ampoules with instructions for use and a vial for opening ampoules or a scarifier ampoule is placed in a box of cardboard for consumer packaging.

    5 or 10 ampoules are placed in a contoured cell pack of a polyvinylchloride film or polyethylene terephthalate tape and aluminum foil or paper with a polyethylene coating or without a foil, or without paper.

    For 1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed 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.

    Storage conditions:

    Store in a dark place at a temperature of 2 to 25 ° ะก2 Keep out of reach of children.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004371
    Date of registration:10.07.2017
    Expiration Date:10.07.2022
    The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.09.2017
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