Dimedrol-Darnitsa
Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine
Code of automatic telephone exchange: R06AA02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: diphenhydramine;
1 tablet contains a difengidramin of a hydrochloride of 50 mg;
excipients: potato starch, lactose monohydrate, stearic acid.
Pharmacological properties:
Pharmacodynamics. Antihistamine. Blocks H1 - histamine receptors, ustrayony effects of a histamine: reduces or warns spasms of smooth muscles of vessels, intestines, bronchial tubes and bronchioles, a hyperpermeability of capillaries, hypostasis of fabrics, an itch an igiperemiya. Antihistaminic effect of Dimedrol is more expressed concerning local sosuyodisty reactions at an inflammation and an allergy, than system (decrease arterial a davleyoniya). Has mestnoanesteziruyushchy effect (at intake causes a kratkovremenyony feeling of numbness of mucous membranes of an oral cavity), has spasmolytic, ganglioblokiruyushchy and central cholinolytic activity. Renders sedative, snoyotvorny (more expressed at repeated receptions) and moderately expressed antiemetic action. Influence on the central nervous system is caused by blockade of H3-histamine receptors of a brain and oppression of the central cholinergic structures. Is more effective at the bronchospasm caused by histamine liberator (tubocurarine, morphine, Sombrevinum) and is less active at an allergic bronchospasm.
Pharmacokinetics. At intake it is quickly and well soaked up in digestive tract. Linkng with proteins of plasma makes 98-99%. The maximum concentration in a blood plasma is reached in 1-4 hours after oral administration. The most part of the entered dose is metabolized generally in a liver with formation of difenilmetoksiuksusny acid, menyyoshy – is removed in not changed look by kidneys. It is well distributed in an organism, gets through a blood-brain barrier, comes to breast milk that can cause sedation in children when breastfeeding.
The elimination half-life makes 2-8 hours. It is excreted by kidneys preferential in not changed look within 24-48 hours. The effect of drug develops in 15-30 minutes after intake, the maximum effect is observed in 1-3 hours. Action duration – from 4 to 6 hours.
Pharmaceutical characteristics.
Main physical and chemical properties: tablets of white color, a ploskotsilindrichesky form, with a facet and risky.
Indications to use:
Treatment of allergic reactions: small tortoiseshells, hay fever, Quincke's disease, serum disease; contact dermatitis, multiformny exudative erythema, eczema, skin itch, hemorrhagic vasculitis (capillary toxicosis), vazomotoryony rhinitis, respiratory allergosis, acute iridocyclitis.
Allergic diseases of eyes (conjunctivitis).
For prevention and treatment of allergic complications, сцелью weakening of collateral effekyot from reception of medicines (antibiotics, enzymes), at hemotransfusion or blood-substituting liquid.
Chorea, sea and air diseases, Menyer's disease.
As calming and a hypnagogue at neurosis, a neurasthenia, insomnia.
Route of administration and doses:
To adult patients appoint on a ½-1tabletka (25-50 mg of a difengidramin of a hydrochloride) 1-3 times a day. For prevention of a motion desease accept ½-1 a tablet in 30-60 minutes prior to a trip as calming and a hypnagogue – 1 tablet before going to bed.
For adults the maximum single dose makes 2 tablets (100 mg of a difengidramin of a gidyorokhlorid), the maximum daily dose – 5 tablets (250 mg of a difengidramin of a hydrochloride). To children of 6-12 years appoint ½ tablets (25 mg of a difengidramin of a hydrochloride) to reception. Duration of a course of treatment is established individually (on average 10-15 days).
Features of use:
Use during pregnancy or feeding by a breast.
Dimedrol is contraindicated in период to pregnancy as there are no adequate data on safety and an effektivyonost of its use. In need of use of drug it is necessary to stop kormleyony a breast. Use of Dimedrol during feeding by a breast can cause paradoksalyyony stimulation of TsNS in children of chest age.
Children. Drug is used to children 6 years are more senior.
Patients should appoint Dimedrol with care with a myasthenia or spasms. Tolerance at frequent use can develop. Patients with rare hereditary problems of intolerance of a galactose, deficit of Lapp of lactase or glyukozo-galaktozny мальабсорбциею should not accept Dimedrol.
Apply with care to treatment of patients with a hyperthyroidism, patients with chronic obstructive diseases of lungs, with the increased vnutriglazyony pressure, with diseases of cardiovascular system, and also persons of an elderly vozrasyot.
Drug can cause a xerophthalmus and create inconveniences when carrying contact lenses. During treatment by drug the use of alcoholic beverages is contraindicated, it is necessary to avoid influence of Uv-radiation. Dimedrol use as antiemetic can complicate diagnosis of appendicitis and recognition of symptoms of overdose of a drugiyoma medicines.
Ability to influence the speed of reactions at control of motor transport or work with other mechanisms.
During treatment it is necessary to refrain from occupations potentially opasyony types of activity demanding the increased concentration of attention and speed of psychomotor reactions (control of vehicles, mechanisms, etc.).
Side effects:
From a nervous system and sense bodys: weakness, drowsiness, decrease in attention, reduction in the rate of psychomotor reactions, concern, lacks of coordination of movements, a hyperexcitability (especially at children), sleeplessness, nervousness, irritability, euphoria, confusion of consciousness, fatigue, sedative action, a tremor, neuritis, paresthesias, a rasshiyoreniye of pupils, a diplopia, a vision disorder, an acute labyrinthitis, a sonitus, dizziness, a headache; very seldom – increase in intraocular pressure, a spasm.
From cardiovascular system: arterial hypotension, feeling a serdtsebiyeyoniya, tachycardia, premature ventricular contraction, the complicated breath.
From system of a hemopoiesis: agranulocytosis, thrombocytopenia, hemolitic aneyomiya, hemolitic jaundice.
From digestive tract: dryness in a mouth, numbness of a mucous membrane of a poyolost of a mouth, anorexia, nausea, pain in epigastriums, vomiting, diarrhea, a lock.
From urinogenital system: the frequent and/or complicated urination, a moyocheotdeleniye delay, increase in frequency of periods, early periods.
From a respiratory organs: dryness of a nose and throat, a nose congestion, a condensation of a secret of bronchial tubes, constraint in a thorax.
Allergic reactions: skin rash, itch, small tortoiseshell, acute anaphylaxis.
Others: perspiration, fever, photosensitization, xerophthalmus; very seldom – contact deryomatit.
Interaction with other medicines:
Strengthens effect of ethanol and the means oppressing the central nervous system: neuroleptics, tranquilizers, hypnotic drugs, analgetik, drugs. Monoamine oxidase inhibitors increase anticholinergic activity of Dimedrol. Antagonistic interaction is noted at joint appointment with psychostimulants. Reduces efficiency of Apomorphinum as vomitive at treatment of poisoning. Strengthens anticholinergic effects of medicines with m-holinoblokiruyushchey activity.
It is not necessary to appoint together with drugs which contain Dimedrol, including for topical administration.
At combined use with analeptics increase in risk of development of spasms is possible.
At combined use of Dimedrol with tricyclic antidepressants strengthening of its m-holinoblokiruyushchego of action is possible that can lead to increase in intraocular pressure at glaucoma.
Use of Dimedrol together with hypotensive drugs can strengthen feeling of fatigue.
Dimedrol is inhibitor of an isoenzyme of P450 CYP2D6 cytochrome. Thus, there is a possibility of interaction with drugs which are generally acquired by CYP2D6, such as метопролол and венлафаксин. Dimedrol does not sdedut to use to the patients receiving any of above-mentioned drugs.
Contraindications:
Hypersensitivity to components of drug or to other antihistamines, an attack of bronchial asthma, a pheochromocytoma, epilepsy, a syndrome of an udliyonenny interval of QT or prolonged use of drugs which can extend a QT-interval. Porphyria.
Restrictions to use: closed-angle glaucoma, a prostate hyperplasia, the stenosing peptic ulcer of a stomach and duodenum, a stenosis of a neck uric пузыря, bradycardia, disturbances of a heart rhythm.
Overdose:
Symptoms: dryness in a mouth, the complicated breath, a mydriasis, face reddening, oppression or excitement TsNS, tachycardia, arrhythmia, oppression of function of serdechnoyososudisty system and breath, a depression, a hyperkinesia, confusion of consciousness, nonsense; children have a development of spasms. The case of development of a rabdomioliz after Dimedrol overdose is described.
Treatment: induction of vomiting, gastric lavage, purpose of absorbent carbon; a simptomayotichesky and maintenance therapy against the background of careful control of breath and the ABP level. Intravenous drop administration of plasma substituting liquids, oxygenotherapy. Нельзя to apply Epinephrinum and analeptics.
As an antidote at overdose of Dimedrol it is possible to appoint physostigmine of 0,02-0,06 mg/kg of body weight intravenously several times if anticholinergic symptoms accrue. In случаях overdoses of physostigmine administration of atropine is recommended.
Storage conditions:
To store in protected from light, the place, unavailable to children. A period of validity - 4 years.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in a blister strip packaging; on 1 blister strip packaging in a pack; on 10 tablets in blister strip packagings.