Active substanceDiphenhydramineDiphenhydramine
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  • Dosage form: & nbspSolution for intravenous and intramuscular injection.
    Composition:
    Active substance:
    Diphenhydramine hydrochloride 10.0 mg
    Excipient:
    Water for injection - up to 1.0 ml.
    Description:Transparent colorless liquid.
    Pharmacotherapeutic group:Antiallergic agent (H1-histamine receptor blocker)
    ATX: & nbsp

    A.06.A.A.02   Diphenhydramine

    Pharmacodynamics:
    H1-histamine receptor blocker of the first generation. The effect on the central nervous system is due to the blockade of Hg-histamine receptors in the brain and the inhibition of central cholinergic structures. Removes spasm of smooth muscles (direct action), reduces permeability of capillaries, prevents and weakens allergic reactions, has local anesthetic, antiemetic, sedative effects, moderately blocks cholinergic receptors of vegetative ganglia, and has a hypnotic effect. Antagonism with histamine manifests itself in a greater degree in relation to local vascular reactions in inflammation and allergies than in systemic, ie. lowering blood pressure. However, with parenteral administration, patients with circulating blood volume deficiency may be reducedarterial pressure and strengthening of existing hypotension, due to ganglion blocking action. 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: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 excreted from the tissues after 6 hours. The half-life period is 4-10 hours. Within a day it is completely excreted by the kidneys in the form of metabolites conjugated with glucuronic acid. Essential amounts are excreted in milk and can cause sedation in infants (a paradoxical reaction characterized by excessive excitability may be observed).
    Indications:Anaphylactic and anaphylactoid reactions (in complex therapy); Quincke's edema, serum sickness, other acute allergic conditions (in complex therapy and in cases when the use of a tablet form is impossible).
    Contraindications:
    Hypersensitivity to diphenhydramine, zakratougolnaya glaucoma, prostatic hyperplasia, peptic ulcer of the stomach and duodenum complicated by stenosis, stenosis of the neck of the bladder, epilepsy, children under 7 months. Because of the risk of developing local necrosis, you can not use diphenhydramine as a local anesthetic.
    Carefully:With caution - bronchial asthma, pregnancy, lactation.
    Pregnancy and lactation:With caution, under the strict supervision of a doctor, during pregnancy (adequate and strictly controlled studies in pregnant women are not conducted). Due to the fact that significant amounts are excreted in breast milk and can cause sedation in infants (a paradoxical reaction characterized by excessive excitability can be observed), breastfeeding should be stopped for the duration of treatment.
    Dosing and Administration:
    Intravenous or intramuscular.
    For adults and children over 14 years of age, intravenously or intramuscularly, 1-5 ml (10-50 mg) of 1% solution (10 mg / ml) 1-3 times a day; the maximum daily dose is 200 mg.
    For children aged 7 months to 12 months, 0.3-0.5 ml (3-5 mg), 1 to 3 years, 0.5-1 ml (5-10 mg), 4 to 6 years on 1-1,5 ml (10-15 mg), from 7 till 14 years on 1,5-3 ml (15 30 mg) if necessary every 6-8 hours.
    Side effects:
    From the nervous system:
    drowsiness, weakness, decreased speed of psychomotor reaction, impaired coordination of movements, dizziness, tremor, irritability, euphoria, agitation (especially in children), insomnia.
    From the digestive system:
    nausea, vomiting, discomfort in the epigastric region, anorexia.
    From the respiratory system:
    dryness of the mucous membrane of the oral cavity, nose, bronchi (increased viscosity of sputum).
    From the hematopoiesis:
    hemolytic anemia, thrombocytopenia, agranulocytosis.
    From the cardiovascular system:
    decrease in arterial pressure, tachycardia, extrasystole.
    From the urinary system:
    disturbances of urination.
    Allergic reactions:
    urticaria, photosensitivity, skin rash, itching.
    Overdose:
    Symptoms: oppression or excitation (especially in children) of the central nervous system, depression. Other symptoms of an overdose resemble the action of atropine: dilated pupils, dry mouth, upset of the functions of the gastrointestinal tract. Treatment: there is no special antidote. Gastric lavage. Control
    blood pressure. Symptomatic therapy includes drugs that increase blood pressure, oxygen, introduction of plasma-substituting fluids intravenously. You can not use adrenaline and analeptics.
    Interaction:
    Strengthens the action of ethanol and drugs (LS), depressing the central nervous system.
    Inhibitors of monoamine oxidase (MAO) increase the anticholinergic activity of diphenhydramine.
    Antagonistic interaction is noted when co-administered with psychostimulants.
    Reduces the effectiveness of apomorphine as a vomiting drug in the treatment of poisoning.
    It enhances the anticholinergic effects of drugs with m-cholinoblocking activity.
    Special instructions:
    During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions (driving a car, etc.).
    During treatment with diphenhydramine, UV radiation and the use of ethanol should be avoided.
    Effect on the ability to drive transp. cf. and fur:Diphenhydramine it causes drowsiness and disrupts reaction speed, as a result of which the drug can not be used when driving and working with potentially dangerous equipment.
    Form release / dosage:
    Solution for intravenous and intramuscular injection 10 mg / ml.
    Packaging:
    1 ml per ampoule of colorless neutral glass with a colored break ring or with a colored dot and a notch or without a kink ring, 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 can additionally be applied to the ampoules. 5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.
    1 or 2 contour squares or cardboard trays, together with the instructions for use and a scarifier or knife with an ampoule, or without a scarifier and an ampoule knife, are placed in a cardboard package.
    Storage conditions:
    In the dark place at a temperature of no higher than 30 ° C.Do not freeze.
    Keep out of the reach of children.
    Shelf life:5 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N003089 / 01
    Date of registration:11.02.2008 / 22.12.2015
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.02.2016
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