Active substanceDiphenhydramineDiphenhydramine
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  • Dosage form: & nbspTabletki.
    Composition:

    For one tablet:

    Active substance:

    Diphenhydramine hydrochloride (diphenhydramine)

    - 50 mg

    Auxiliary substances - a sufficient amount to prepare a tablet weighing 150 mg

    Lactose monohydrate (milk sugar)

    - 75 mg

    Potato starch

    - 23.154 mg

    Silica colloidal dioxide (aerosil)

    - 0.760 mg

    Stearic acid

    - 0.760 mg

    Methylcellulose water-soluble

    - 0.326 mg

    Description:Round tablets of white color, flat-cylindrical shape with a bevel.
    Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    A.06.A.A.02   Diphenhydramine

    Pharmacodynamics:

    Blocker H1-gistaminovyh receptors of the first generation. Action on the central nervous system is caused by blockade 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 in a greater degree in relation to local vascular reactions in inflammation and allergies than in systemic, ie. lowering blood pressure.In people with local brain damage and epilepsy activates (even in low doses) epileptic discharges on the electroencephalogram and can provoke an epileptic attack.

    Pharmacokinetics:

    Quickly absorbed in the gastrointestinal tract. Bioavailability - 50%. TSmOh - 20-40 min (in the greatest concentration is determined in the lungs, spleen, nights, liver, brain and muscles). 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 breast milk and can cause sedation in infants (a paradoxical reaction characterized by excessive excitability can be observed).

    Indications:

    Allergic conjunctivitis, allergic rhinitis, chronic urticaria, itchy dermatoses, dermatografism, serum sickness, in complex therapy of anaphylactic reactions, Quincke's edema.

    Insomnia, chorea, Meniere's syndrome, sea and air sickness.

    Contraindications:

    Hypersensitivity to diphenhydramine and other components of the drug, zakratougolnaya glaucoma, prostatic hyperplasia, stenosing stomach and duodenal ulcer, stenosis of the neck of the bladder, bronchial asthma, epilepsy, lactation period, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

    Children under 14 years (for this dosage form).

    Carefully:

    Children age from 14 to 18 years.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to prescribe the drug during lactation, it is necessary to stop the difficult feeding.

    Dosing and Administration:

    Inside.

    Adults and children over 14 years of age 50 mg (1 tablet) 1-3 times a day. The highest single dose is 100 mg, the daily dose is 250 mg.

    When insomnia - 50 mg for 20-30 minutes before bedtime.

    When motion sickness - 50 mg every 4-6 hours if necessary.

    Side effects:

    Allergic reactions: urticaria, photosensitivity, skin rash, itching.

    From the nervous system: drowsiness, general weakness, decreased speed of psychomotor reactions, impaired coordination and rapid reaction, a sense of fatigue. In some cases, excitation (especially in children), insomnia, irritability, dizziness, tremor, euphoria.

    From the digestive system: dryness of the oral mucosa, nausea, vomiting, discomfort in the epigastric region, anorexia.

    From the respiratory system: dryness of the mucous membrane of the nasal cavity, bronchi (increased viscosity of sputum).

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

    From the side of the cardiovascular system: lowering of arterial pressure, tachycardia, extrasystole.

    From the urinary system: urination disorders.

    Overdose:

    Symptoms: oppression of central nervous system functions, development of excitation (especially in children) or depression, pupil dilatation, dry mouth, paresis of the gastrointestinal tract, etc.

    Treatment of overdose: there is no special antidote.

    Gastric lavage.If necessary, symptomatic treatment: 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 in the treatment of poisoning.

    Strengthens the anticholinergic effects of drugs with cholinoblocking activity.

    Special instructions:

    During treatment with diphenhydramine, UV radiation and the use of ethanol should be avoided. 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 with other medications.

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

    During treatment should be abandoned the employment of potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Tablets, 50 mg.
    Packaging:

    10 tablets per contour cell pack.

    For 1, 2, 3 or 5 contour squares, together with the instruction, they are placed in a pack of cardboard.

    Storage conditions:

    Store in a 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.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002932
    Date of registration:30.03.2015
    Expiration Date:30.03.2020
    The owner of the registration certificate:Barnaul Plant of Medical Preparations, LLC Barnaul Plant of Medical Preparations, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp03.11.2016
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