Active substanceDiphenhydramineDiphenhydramine
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  • Dosage form: & nbspRAsterol for intravenous and intramuscular administration
    Composition:

    Active substance:

    Diphenhydramine hydrochloride (diphenhydramine) - 10 mg

    Excipient:

    water for injection - up to 1 ml.

    Description:Pcolorless liquid.
    Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    A.06.A.A.02   Diphenhydramine

    Pharmacodynamics:

    Block H1-gistaminovyh receptors of the first generation. The effect on the central nervous system is due to the blockade of H1histamine receptors and brain m-cholinergic receptors. Reduces or prevents histamine-induced spasms of smooth muscles, increased capillary permeability, tissue swelling, pruritus and hyperemia, has a local anesthetic, antiemetic, sedative effects, has a hypnotic effect. Antagonism with histamine manifests itself more in relation to local vascular reactions in inflammation and allergies than to systemic ones, that is, lowering blood pressure. However, with parenteral administration, patients with circulating blood volume deficiency may reduce blood pressure and increase the existing hypotension.In people with local brain damage and epilepsy activates (even in low doses) epileptic discharges on the electroencephalogram and can provoke an epileptic attack.

    The action develops within a few minutes, the duration is up to 12 hours.

    Pharmacokinetics:

    Bioavailability - 50%. Time to maximum concentration - 20-40 minutes (the highest concentration is determined in the lungs, spleen, kidney, liver, brain, and muscle). The connection with plasma proteins is 98-99%. Penetrates through the blood-brain barrier. Metabolized mainly in the liver, in part - in the lungs and kidneys.

    It is removed from the tissues after 6 hours. The elimination half-life is 4-10 hours. Within a day is completely excreted by the kidneys in the form of metabolites conjugated with glucuronic acid. Substantial amounts are excreted in the milk and may cause sedation in children who are breastfed (paradoxical reaction characterized by hyperexcitability may occur).

    Indications:In complex therapy - anaphylactic and anaphylactoid reactions, Quincke's edema, serum sickness.
    Contraindications:

    Hypersensitivity, lactation, zakratougolnaya glaucoma, prostatic hyperplasia, stenosing stomach and duodenal ulcer, stenosis of the neck of the bladder, bronchial asthma, epilepsy, children under 7 months.

    Carefully:

    Increased intraocular pressure, hyperthyroidism, arterial hypertension, diseases of the cardiovascular system, bronchopulmonary diseases.

    Pregnancy and lactation:

    When pregnancy is used only if the intended benefit to the mother exceeds the potential risk to the fetus.

    For the duration of treatment, breastfeeding should be discontinued.

    Dosing and Administration:

    Intravenous or deep intramuscular.

    For adults and children over 14 years intravenously or deep intramuscularly 1-5 ml of a solution of 10 mg / ml (10-50 mg) 1-3 times a day; the maximum daily dose is 200 mg.

    For children aged 7 months to 12 months by 0.3-0.5 ml (3-5 mg), from 1 year to 3 years 0.5-1: ml (5-10 mg), from 4 to 6 years 1-1.5 ml (10-15 mg), from 7 to 14 years on 1,5-3 ml (15-30 mg) if necessary every 6-8 hours.

    Side effects:

    From the side of the cardiovascular system: lowering blood pressure, palpitations, tachycardia, extrasystole;

    From the respiratory system: dryness of the mucous membrane of the nose and throat, increased viscosity of phlegm, a feeling of compression in the chest or throat, heavy breathing, sneezing, nasal congestion.

    From the nervous system: headache, sedation, loss of attention, drowsiness, dizziness, impaired coordination of movements, general weakness, fatigue, confusion, anxiety, increased excitability, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, neuritis, convulsions.

    From the sense organs: impaired visual perception; diplopia, vertigo, noise in the ears, sharp labyrinth.

    From the digestive system: dry mouth, epigastric pain, anorexia, nausea, vomiting, diarrhea, constipation.

    From the genitourinary system: rapid and / or difficult urination, delay in urination, early menstruation;

    On the part of the organs of hematopoiesis: hemolytic anemia, thrombocytopenia, agranulocytosis.

    Allergic reactions: urticaria, drug rash, anaphylactic shock.

    Other: increased sweating, chills, photosensitivity.

    Overdose:

    Symptoms: depression of the central nervous system, the development of excitation (especially in children) or depression, dilated pupils, dry mouth, paresis of the organs of the gastrointestinal tract.

    Treatment: there is no specific antidote, gastric lavage, if necessary - drugs that increase blood pressure, oxygen, intravenous injection of plasma-substituting fluids;

    Can not use epinephrine and analeptics.

    Interaction:

    Strengthens the action of ethanol and drugs that depress the central nervous system.

    Monoamine oxidase inhibitors increase the anticholinergic activity of diphenhydramine.

    Antagonistic interaction is noted when co-administered with psychostimulants.

    Reduces the effectiveness of apomorphine as an emetic drug in the treatment of poisoning.

    Enhances the anticholinergic effects of drugs with m-cholinoblocking activity.
    Special instructions:

    Do not administer subcutaneously due to irritant effect.

    During treatment with diphenhydramine, you should avoid ultraviolet radiation and use of ethanol.

    It is necessary to inform the doctor about the use of this drug: an antiemetic effect may make it difficult to diagnose appendicitis and to recognize the symptoms of an overdose of other medicines.

    Effect on the ability to drive transp. cf. and fur:Taking into account possible side effects, during the treatment period, one should refrain from driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    A solution for intravenous and intramuscular administration, 10 mg / ml.

    Packaging:

    1 ml in ampoules. 10 ampoules are placed in a box of cardboard with corrugated septa.

    5 ampoules are placed in a contour mesh package, from a polyvinyl chloride film. 2 contour squares are placed in a pack of cardboard.

    Each instruction pack or box is supplied with instructions for use, an ampoule knife or a scarifier (when packing ampoules with a kink ring, notches and dots, the ampoule knife or scarifier does not insert).

    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 expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001412
    Date of registration:23.05.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp03.11.2016
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