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

    Composition per ml:

    Active substance: chloropyramine hydrochloride 20 mg.

    Excipient: water for injection - up to 1 ml.

    Description:Pcolorless or slightly yellowish, or slightly 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 H1-gistaminovyh receptors. The chemical structure refers to the derivatives of ethylenediamine. Chloropyramine selectively blocks H1-gistaminovye receptors and reduces the permeability of capillaries. Prevents development and facilitates the course of allergic reactions. Has sedative, antihistaminic, m-holinoblokiruyuschee and pronounced antipruritic effect. Has moderate spasmolytic activity and antiemetic effect.

    Pharmacokinetics:

    Evenly distributed in the body, including the central nervous system. Penetrates through the blood-brain barrier. The association of chloropyramine with plasma proteins is 7.9%. The binding peak was noted at pH 6.8-7.4. Therapeutic concentration persists 4-6 hours. Intensively metabolized in the liver.

    It is excreted mainly by kidneys in the form of metabolites. The excretion of chloropyramine in children can occur faster than in adults.

    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:

    - Individual hypersensitivity to chloropyramine or the components of the drug;

    - acute attack of bronchial asthma;

    - newborn children (full and premature);

    - pregnancy and the period of breastfeeding.

    Carefully:

    The drug should be administered with caution to elderly patients, with insufficient liver and / or kidney function, cardiovascular disease, urinary retention, prostatic hyperplasia, and closed-angle glaucoma.

    Pregnancy and lactation:

    There have been no adequate, with proper control, studies of the use of antihistamines in pregnant women. Chloropyramine contraindicated in pregnancy.

    If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    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 1-12 months - 5 mg (0.25 ml - ΒΌ ampoules) intramuscularly.

    Children aged 1-6 years - 10 mg (0.5 ml - ½ ampoules) intramuscularly.

    Children aged 6-14 years - 10-20 mg (0.5-1 ml - ½ - 1 ampoule) intramuscularly.

    The dose can be carefully increased depending on the patient's response and the observed side effects. The daily dose should never exceed 2 mg / kg 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: The use of chloro-pyramine requires extreme caution. In these patients, antihistamines often cause side effects (dizziness, drowsiness).

    Patients with impaired hepatic function: may require a dose reduction 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:

    Side effects usually occur extremely rarely, are temporary, go through with the withdrawal of the drug.

    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 cardiovascular system: decrease in arterial 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: leukopenia, agranulocytosis, hemolytic anemia, other pathological changes in the cellular composition of the blood.

    From the side of the urinary system: difficulty and delay of urination.

    From the side of the organ of vision: increased intraocular pressure, an attack of 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.

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

    Overdose:

    Symptoms: hallucinations, anxiety, ataxia, impaired coordination of movements, athetosis, convulsions. In young children - excitement, anxiety, dry mouth, fixed dilated pupils, reddening 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. There is no specific antidote.

    Interaction:

    Chloropyramine 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 allergic skin tests,therefore, a few 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 increase the symptoms of reflux esophagitis. Chloropyramine can strengthen the effect of alcohol on the central nervous system, in connection with what during the administration of the drug Chloropyramine should be avoided consumption 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 results of the analysis 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 colorless neutral glass type I with a colored dot and a notch. On the ampoules may additionally be applied one color ring.

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

    1 or 2 contour packagings along with the instruction for use are placed in a cardboard package (bundle).

    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004458
    Date of registration:12.09.2017
    Expiration Date:12.09.2022
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp03.10.2017
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