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

    1 ampoule (1 ml) contains as active substance chloropyramine hydrochloride (in terms of 100% substance) - 20 mg; Excipients: water for injection - up to 1 ml.

    Description:

    colorless or slightly yellowish, or slightly greenish transparent 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 is a blocker H1-gistaminovyh receptors. The chemical structure refers to the derivatives of ethylenediamine. Chloropyramine selectively blocks H1- histamine 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 for 4-6 hours. Intensively metabolized in the liver. It 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:

    - treatment of symptoms of year-round and seasonal allergic rhinitis and allergic conjunctivitis;

    - Pollinosis (hay fever);

    - hives;

    - allergic dermatoses;

    - drug allergy;

    - allergic reactions to insect bites;

    - angioedema;

    - serum sickness.

    Contraindications:

    - individual hypersensitivity to the drug or its components;

    - acute attack of bronchial asthma;

    - simultaneous use of monoamine oxidase inhibitors;

    - newborn children (up to 1 month);

    - pregnancy and lactation;

    - gastric ulcer in the acute stage;

    - hyperplasia of the prostate;

    - severe respiratory failure.

    Carefully:

    - individual hypersensitivity to the drug or its components;

    - acute attack of bronchial asthma;

    - simultaneous use of monoamine oxidase inhibitors;

    - newborn children (up to 1 month);

    - pregnancy and lactation;

    - gastric ulcer in the acute stage;

    - hyperplasia of the prostate;

    - severe respiratory failure.

    Dosing and Administration:

    Intravenous or intramuscular.

    Adults appoint 20-40 mg per day (the contents of 1-2 ampoules).

    Treatment in children begins with a dose of 5 mg (0.25 ml). In the future, the dose is increased depending on the age of the child.

    Children aged 1-12 months - 5 mg (0.25 ml).

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

    Children aged 7-18 years - 10-20 mg (0.5-1 ml).

    The daily dose should not exceed 2 mg / kg of body weight.

    In severe allergy, treatment should begin with an injection form of chloropyramine. Initially, it is administered intravenously slowly, then it is switched to intramuscular injection and in the final phase of treatment they switch to taking the tablets inside. The terms of treatment are set individually depending on the clinical symptoms and the patient's condition.

    Special patient groups

    Elderly, emaciated patients: use of the drug chloropyramamine requires special care, because In these patients, antihistamines often cause side effects (dizziness, drowsiness).

    Patients with impaired liver 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: lethargy, weakness, drowsiness, dizziness, headache, euphoria, a feeling of fatigue, irritability, tremors, convulsions, impaired coordination of movements, impaired vision; children may have some stimulating effect on the central nervous system, manifested by anxiety, increased irritability, insomnia.

    On the part of the digestive system: dry mouth, nausea, vomiting, gastralgia, diarrhea / constipation, loss or increase in appetite.

    From the side of the urinary system: difficulty urinating.

    From the cardiovascular system: decrease in blood pressure (more often in elderly patients), tachycardia, arrhythmia.

    On the part of the hematopoiesis system: very rarely - leukopenia, agranulocytosis.

    On the part of the organs of vision: increased intraocular pressure.

    Allergic reactions to the drug.

    Other: photosensitivity, muscle weakness.

    Overdose:

    Symptoms: children - excitement, anxiety, hallucinations, athetosis, ataxia, convulsions, mydriasis, pupil immobility, hyperemia of the facial skin, hyperthermia; then - a collapse, a coma. In adults, oppression (inhibition,depression) or excitation of the central nervous system (psychomotor agitation), very rarely - hallucinations, coordination disorder, pupil dilated and lack of response to light, dry mouth, hyperthermia and hyperemia of the skin, convulsions, in severe cases - coma.

    Treatment: symptomatic therapy (including the appointment of antiepileptic drugs, caffeine, phenamine), resuscitation, artificial ventilation - according to the indications. There is no specific antidote.

    Interaction:

    Strengthens the effect of drugs for general anesthesia, hypnotics, sedatives, tranquilizers, m-holinoblokatorov, opioid analgesics, local anesthetics.

    Tricyclic antidepressants and monoamine oxidase inhibitors increase m-cholinoblocking and inhibitory effects on the central nervous system.

    Caffeine and phenamine reduce the inhibitory effect on the central nervous system. Simultaneous use with ethanol is not recommended (risk of severe CNS depression).

    Special instructions:

    During treatment, it is unacceptable to drink alcoholic beverages.Taking the drug at night can increase the symptoms of reflux esophagitis. If during long-term use of the drug is observed wanton fever, laryngitis, pallor, jaundice, ulceration of the oral mucosa, bruising, unusual and trudnoostanavlivaemye bleeding, seek medical attention because prolonged treatment with antihistamines may lead to violations hemopoiesis. Antihistamines can distort the reaction when setting skin allergological tests, therefore, a few days before the planned test, the drug should be discontinued. When combined with ototoxic drugs chloropyramamine can mask the early manifestations of ototoxicity.

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

    Patients using chloropyramamine, it is recommended to refrain from driving vehicles, working with mechanisms, as well as from other activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

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

    Packaging:

    1 ml per ampoule of colorless neutral glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

    5 ampoules per contour cell pack. 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:

    5 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001031
    Date of registration:19.05.2011
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.09.2015
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