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Dermodrin 100 ml oral solution




The instruction for medical use of Dermodrin Torgovoye medicine a name Dermodrin Mezhdunarodnoye the unlicensed name Difengidramin Lekarstvennaya a form Solution for intake, 100 ml Structure of 100 ml of drug contain active agents: difengidramina hydrochloride of 0.2000 g, excipients: hydroxyethylcellulose, sorbitol, sodium cyclomate, E951 aspartame, sodium saccharin, fragrance cherry, citric acid monohydrate, sodium were marked by E219 parahydroxybenzoate, water purified. Description Transparent, colourless solution Pharmacotherapeutic group Antihistaminic drugs of systemic action. Aminoalkyl ethers. Difengidramin. The ATX R06AA02 code the Pharmacological Difengidramin’s Pharmacokinetics properties a hydrochloride is very easily dissolved in water, quickly and almost is completely soaked up after oral administration. Peak levels in blood plasma are reached from 1 to 4 hours after single oral administration. The beginning of action after single dose of a dose of 50 mg of a difengidramin: 15-30 minutes. Action duration – 4-6 hours, up to 1.9 days in case of skin allergic reactions. Difengidramin is quickly distributed in an organism, gets through a blood-brain barrier and a placenta, is allocated in breast milk. At patients with cirrhosis of 70-85% of a difengidramin contacts proteins of plasma. It is metabolized in a liver of 50% of a difengidramin, demetilirovanny difengidramin (DMDF) it was found in urine in the form of an inactive main metabolite. Less than 4% are brought out of an organism with urine in not changed form. After reception of 100 mg the removal with urine makes 64% and after repeated oral introduction of 50 mg – 49% within 96 hours. After oral administration of 50 mg of a difengidramin of a hydrochloride, elimination half-life makes 9.2 ± 2.5 hours. Elimination half-life depends on age, and can make 13.5 ± 4.2 hours at elderly patients and less than 5.4 ± 1.8 hours at children. The general clearance decreases with increase in age, after one dose (1.25 mg/kg of body weight), the clearance is 49 ml/min. at children, young adults have 23 ml/min. and elderly patients have 12 ml/min. Dermodrin’s pharmacodynamics – a blocker of H1 receptors, a difengidramin a hydrochloride. On the other hand, the effects of a histamine mediated by H2 – receptors (for example, increase in secretion of gastric juice) remain invariable. In addition to antihistaminic antiallergic effects, it also has noticeable sedative and antiemetic effect and also anticholinergic (parasympatolytic, spasmolytic) and antipruritic effect. Difengidramina a hydrochloride also has atropinopodobny effect and anticonvulsant action. Nevertheless, at reception, spasms at predisposed patients and in case of overdose are possible. Besides, it was described local anesthetic effect. Thanks to noted hypnotic and to sedation, Dermodrin facilitates approach of a dream and increases its duration. Indications – for the supporting treatment of allergic reactions, such as pollinosis, allergy to food and medicines, allergic rhinitis, small tortoiseshell, itching, dermatitis, contact dermatitis, pruritic rashes, hypostasis of a mucous membrane. – for treatment of disturbance of backfilling and for maintenance of a dream (in insomnia) various etiology (concern, nervousness, exhaustion). Drug facilitates approach of a dream and increases dream duration at disturbances which are followed by an itching or allergic symptoms. The route of administration and a dosage For convenience of dosing is applied the syringe doser or a measured cap. Antihistaminic, antiallergic means: To adults and teenagers at the age of 12 years is also more senior appoint 15-45 ml of drug 2-3 times a day. Dermodrin appoint according to the following scheme of dosing: The age the Daily dose up to 2 years twice of 2.5 ml daily 3 – 5 years 2 – 3 times of 5 ml daily 6 – 9 years 3 – 4 times of 5 ml daily 10 years is also more senior 3 times of 10 ml a day Hypnotic, sedative: To adults and teenagers at the age of 12 years is also more senior appoint 15-30 ml (45 ml at most) once in 15-30 minutes prior to a dream. To children Dermodrin appoint according to the following scheme of dosing: The age the Daily dose up to 2 years of 2.5 ml of 3 – 5 years of 5 ml of 6 – 9 years of 7.5 ml of 10 years is also more senior than 10 ml Adult do not appoint the single dose exceeding 45 ml. At the elderly or weakened patients and patients with a heavy renal or liver failure, the dosage should be modified according to a clinical picture. A dosage at elderly patients (old age): If it is necessary, use lower initial dose since with increase in a dose the development of undesirable reactions is possible (dizziness, sedation, a lowering of arterial pressure). A dosage in a renal failure: increase in an interval between receptions is recommended till 6-12 o’clock at SKF 10-50/mines or 12-18 of hours of ml at SKF & lt, 10 ml/min. In long sleep disorders, the need for treatment is reconsidered after two weeks of daily oral administration. Side effects the Following these frequencies are used for assessment of undesirable effects: – Very often  1/10) – Often  1/100 to & lt, 1/10) – Infrequently  1/1000 to & lt, 1/100) – Seldom  1/10000 & lt, 1/1000) – Is very rare (& lt, 1/10000) – does not know (it cannot be estimated on the available data). Disturbances from blood and lymphatic system Very seldom: pathological changes of blood (granulocytopenia, a leukopenia, thrombocytopenia, hemolytic anemia) of Disturbance from nervous system Very often: fatigue. When using as sleeping pill, it is the main desirable effect, when using as antihistamine and in antiallergic means, it is undesirable effect. Infrequently: dizziness, drowsiness, headache, disturbance of concentration of attention and coordination, muscle weakness. At reception for the night, the hungover syndrome (disturbance of speed of reaction) which depends on time and a dosage is possible in the morning. Very seldom, especially at children: paradoxical reactions in the form of excitement of central nervous system, such as concern, irritability, uneasiness and tremor. Disturbances from an organ of sight Infrequently: disorder of vision, increase in intraocular pressure. Disturbances from heart it is rare: Disturbance tachycardia from vessels Infrequently: instability of blood circulation of Disturbance from the respiratory system, bodies of a thorax and mediastinum Infrequently: a thickening of bronchial slime, morbidity in the Disturbance breast from digestive tract, kidneys and urinary tract Infrequently: gastrointestinal disorders (nausea, vomiting, diarrhea, a constipation, a gastroesophageal reflux) and the Disturbance dysuria from a liver and biliary tract it is rare: liver dysfunction (cholestatic jaundice) is in certain cases observed during treatment with antihistaminic drugs. Disturbances from skin and hypodermic fabric Infrequently: dryness in a mouth, a nose and a throat it is rare: allergic skin reactions, contact dermatitis and a photosensitization of skin (to avoid direct exposure to sunlight). Contraindications – hypersensitivity to active and auxiliary components of drug – 1 trimester of pregnancy, the lactation period – a bad attack of asthma – a narrow angle glaucoma – a pheochromocytoma – spasms (eclampsia, epilepsy) – the accompanying reception with alcohol – adjuvant therapy with medicines which can extend QT interval on the ECG (for example, antiarrhytmic means of the class IA and III) – a concomitant use of Dermodrin with other medicines which contain difengidramin or other H1 antihistaminic drugs – a concomitant use with MAO inhibitors – rare hereditary intolerance of fructose – phenylketonuria Medicinal interactions At simultaneous use of Dermodrin in the big square: – with tricyclic antidepressants, atropine – can strengthen anticholinergic action of a difengidramin, – with psychotropic, sleeping medicines, opiodny analgetics, antihypertensives, alcohol – mutual strengthening of effects of the used drugs. – with adjuvant therapy by medicines which can extend QT interval on the ECG (for example, antiarrhytmic means of the class IA ​​ and III). Special instructions Should be applied Dermodrin with care at: – chronic respiratory disturbances or asthma – the stenosing gastric or intestinal ulcer, a stomach pyloric stenosis – a prostatauxe and a dysuria – dysfunction of heart, cardiac arrhythmia, tachycardia – a hyperthyroidism – an abnormal liver function and kidneys (reduced dose) Dermodrin reduces concentration of attention, at children perhaps excited state. Dermodrin can provoke false-negative result of allergy tests. Therefore Dermodrin’s reception needs to be stopped at least in 3 days prior to test capture. Not to accept Dermodrin after midnight if the next morning the increased concentration of attention is required. Patients with rare hereditary problems of intolerance of fructose should not appoint Dermodrin liquid. Medicine contains aspartame as a source of phenylalanine and can be dangerous to patients with phenylketonuria. Also drug contains sodium methylhydroxybenzoate which can cause allergic reactions (perhaps, with a delay). Pregnancy and the period of a lactation Dermodrin is contraindicated in the first trimester of pregnancy as epidemiological data of limited number of the pregnant women accepting difengidramin in the first trimester indicate the increased formation of a wolf mouth. Researches with animals indicate reproductive toxicity. In connection with insufficient data on safety, drug should not be used at pregnancy. Drug is contraindicated in the period of a lactation as it difengidramin is emitted with breast milk. Features of influence on ability to run the vehicle or potentially dangerous mechanisms Considering possible side effects, such as drowsiness, it is necessary to be careful at control of vehicles. Overdose Symptoms: from central nervous system, such as concern, psychosis, hyperreflexia, loss of consciousness, disturbance of breath or cardiac arrest. Other symptoms: the mydriasis, tachycardia, fever, hot and red skin or dryness of mucous membranes and symptoms reminding intoxication atropine. Exceptional cases of a rhabdomyolysis were described after overdose from a difengidramin by a hydrochloride. Treatment: symptomatic, as antidote physostigmine of 0.02-0.06 mg/kg of weight in / can be used century. A form of release and packing On 100 ml of drug in a bottle from dark glass with the white screwing-up cover. The bottle with the syringe doser with graduation from 0.5 to 10 ml or a measured cap together with the instruction for medical use in the state and Russian languages is placed in a box of cardboard. To Store storage conditions at a temperature not above +25ºС in original packing for protection against light. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer “Montavit Ges. m b. X “, Zaltsbergstrasse 96, A-6067 Abzam, Austria Owner of the registration certificate “Montavit Ges. m b. X “, Zaltsbergstrasse 96, A-6067 Abzam, Austria the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of Sabipharm LLP, the Republic of Kazakhstan, Almaty, Al-Farabi 19, block 1B, office 202 the Address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sabipharm LLP, the Republic of Kazakhstan, Almaty, Al-Farabi 19, block 1B, office 202
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