Composition
1 tablet contains: Active ingredient: dimenhydrinate 50 mg;
excipients: microcrystalline cellulose, povidone (collidone 30), crospovidone, mannitol, colloidal silicon dioxide (aerosil), magnesium stearate.
Pharmacological action
Pharmacotherapeutic group: H1-histamine receptor blocker
ATX code: R06AX
Pharmacological properties
Pharmacodynamics : blocks histamine H1-receptors and M-cholinergic receptors of the central nervous system. Depresses the vestibular apparatus of the inner ear, acting primarily on the otoliths, in high doses-on the semicircular channels. It has antiemetic, anorexic, sedative effects, eliminates dizziness. Pharmacokinetics: after oral use, dimenhydrinate is well absorbed and distributed to organs and tissues. The effect of the drug manifests itself in 15-30 minutes and persists for 3-6 hours. About 78% of dimenhydrinate binds to plasma proteins. Dimenhydrinate is metabolized in the liver and is almost completely excreted in the urine within 24 hours. Small amounts are excreted in breast milk. The half-life (T 1/2) of dimenhydrinate is about 3.5 hours.
Indications
* Motion sickness (sea, automobile, air sickness). * Prevention and treatment of symptoms of vestibular and labyrinth disorders (dizziness, nausea, vomiting), with the exception of symptoms caused by antitumor therapy. * Meniere’s disease.
Use during pregnancy and lactation
The use of the drug in the II-III period of pregnancy is possible only if the expected benefit to the mother exceeds the potential risk to the fetus. The use of the drug in the first trimester of pregnancy and during breastfeeding is contraindicated. Breast-feeding should be discontinued for the duration of treatment.
Contraindications
Hypersensitivity to the components of the drug, epilepsy, acute exudative and vesicular dermatoses, children under 3 years of age, pregnancy (I trimester), breastfeeding.
With cautionConvulsive syndrome, angle-closure glaucoma, prostatic hyperplasia, bronchial asthma, cardiovascular diseases, hyperthyroidism, peptic ulcer stenosis, pyloroduodenal obstruction and bladder neck obstruction.
Side effects
Parameters for the frequency of side effects: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (
Blood and lymphatic system disorders: very rare: hemolytic anemia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia or pancytopenia.
Immune system disorders: rare: anaphylactic shock.
Mental disorders: often: mood swings, restlessness, stiffness of movement; infrequently: insomnia.
Nervous system disorders: common: drowsiness; infrequently: impaired sense of balance, impaired concentration and memory loss (more often in elderly patients), tremor, lack of coordination, confusion, hallucinations; rarely: headache, sleep disturbance, dizziness, orthostatic hypotension; very rare: paradoxical stimulation of the central nervous system (especially in children).
Visual impairment: rare: glaucoma, vision problems (dilated pupil, blurred vision, or split image).
Hearing disorders and labyrinth disorders: rare: ringing in the ears.
Cardiac disorders: rare: rapid heartbeat, tachycardia, and hypotension.
Respiratory, thoracic and mediastinal disorders: often: nasal congestion.
Gastrointestinal disorders: common: dry mouth, constipation, diarrhea, nausea, abdominal pain.
Liver and biliary tract disorders: unspecified frequency: impaired liver function (cholestatic jaundice).
Skin and subcutaneous tissue disorders: rare: rash, redness.
Renal and urinary tractdisorders: common: violation of urination (urinary retention due to anticholinergic action).
General disorders and disorders at the injectionsite: rare: edema (less often-angioedema).
If any of the side effects listed in the instructions get worse, or you notice any other side effects that are not listed in the instructions, tell your doctor!
Interaction
Increases the effects of atropine, tricyclic antidepressants, catecholamines, barbiturates, alcohol, sedatives and sleeping pills, neuroleptics, weakens the effect of corticosteroids, anticoagulants. Reduces the reaction to apomorphine. Reduces the depressive effect of acetylcholine on the heart muscle. Combination with bismuth drugs, scopolamine, painkillers and psychotropic drugs increases the likelihood of visual impairment. Incompatible with ototoxic antibiotics (streptomycin, neomycin, biomycin, amikacin, kanamycin), as it may mask the symptoms of ototoxicity and contribute to the development of irreversible hearing impairment.
How to take, course of use and dosage
Inside, before eating.
Traffic diseases (sea, automobile, air diseases):
children from 3 to 6 years — 1/4-1/2 tablets 2-3 times a day;
children from 7 to 12 years-1/2-1 tablet 2-3 times a day;
children over 12 years and adults-1-2 tablets 2-3 times a day.
Prevention and treatment of symptoms of vestibular and labyrinth disorders (dizziness, nausea, vomiting), except for symptoms caused by anticancer therapy:
children 3 to 6 years — 1/4-1/2 tablet 2-3 times a day;
children from 7 to 12 years — 1/2-1 tablet 2-3 times a day;
children over 12 and adults — 1-2 tablets 2-3 times a day.
Meniere‘s disease:
children from 3 to 12 years-1/2-1 tablet 2-3 times a day;
children over 12 years and adults-1-2 tablets 2-3 times a day.
The maximum daily dose for adults should not exceed 7 tablets. To prevent kinetosis, take 1-2 tablets 30 minutes before the trip. The duration of use of the drug and the possibility of repeating the course of treatment – as agreed by the doctor.
Overdose
Symptoms of overdose: dry mouth, nose and throat, redness of the face, slow and difficult breathing, confusion, seizures in children, hallucinations. If these symptoms appear, you should immediately consult a doctor.
Treatment: gastric lavage with a suspension of activated carbon (20-30 g), use of a saline laxative (10-15 g of sodium sulfate), symptomatic therapy, for convulsions in children – phenobarbital (5-6 mg / kg), diazepam.
Description
Round flat-cylindrical tablets of white or almost white color with a chamfer and a cross-shaped risk.
Special instructions
Ability to influence the reaction rate when driving vehicles or working with other mechanisms
Given the side effects, caution should be exercised when engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions (including driving vehicles).
Form of production
Tablets 50 mg.
5 or 10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.
1,2 contour cell packages together with the instructions for use are placed in a pack of cardboard.
Storage conditions
At a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf
life is 3 years. Do not use after the expiration date indicated on the package.
Active ingredient
Dimenhydrinate
Dosage form
Tablets
Purpose
Children over 3 years of age, Pregnant women in the second and third trimester as prescribed by a doctor, Children as prescribed by a doctor, Adults
Indications
Meniere’s Disease, Seasickness
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