Dramina, tablets 50 mg 10 pcs

H1-histamine receptor blocker

ATX code: R06AX

Pharmacological properties

Pharmacodynamics:

Blocks histamine H1-receptors and M-cholinoreceptors of the central nervous system. Inhibits the vestibular apparatus of the inner ear, acting primarily on the otoliths, in high doses on the semicircular canals. It has antiemetic, anorexigenic, sedative, moderate anti-allergic effect, eliminates dizziness.

Pharmacokinetics:

After oral administration the drug is well absorbed and distributed to organs and tissues. The action of the drug takes 15-30 minutes and lasts for 3-6 hours. It is almost completely eliminated from the body with urine within 24 hours. Small amounts are excreted with breast milk.

Indications

– Motion sickness (motion sickness, car sickness, air sickness);

– Prevention and treatment of symptoms of vestibular and labyrinthine disorders (dizziness, nausea, vomiting), except for symptoms caused by anticancer therapy;

Meniere’s disease.

Active ingredient

Composition

1 tablet contains:

active ingredient – dimenhydrinate 50 mg;

excipients:

Lactose monohydrate, 112.86 mg;

Microcrystalline cellulose, 57.50 mg,

magnesium stearate – 1.150 mg;

povidone K30 – 4.247 mg;

crospovidone – 4.247 mg.

How to take, the dosage

Internal, before meals:

– motion sickness (motion sickness, car sickness, air sickness):

Children 3 to 6 years – 1/4 -1/2 tablets 2-3 times a day; children 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 labyrinthine disorders (dizziness, nausea, vomiting), except for symptoms caused by anticancer therapy:

Children 3 to 6 years old – 1/4 to 1/2 tablet 2-3 times daily; children 7 to 12 years old – 1/2 to 1 tablet 2-3 times daily; children over 12 years old and adults – 1-2 tablets 2-3 times daily;

Meniere’s disease:

Children from 3 to 12 years of age – 1/2 to 1 tablet 2-3 times a day; children over 12 years of age and adults 1-2 tablets 2-3 times a day.

The maximum daily dose for adults should not exceed 7 tablets. For prophylaxis of kinetosis it is necessary to take 1-2 tablets 30 minutes before a trip. The duration of the drug and the possibility of repeating the course of treatment are subject to agreement with the doctor.

Interaction

It enhances the effects of atropine, tricyclic antidepressants, catecholamines, barbiturates, alcohol, sedatives and hypnotics, neuroleptics, weakens the effect of corticosteroids, anticoagulants.

Limits the response 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.

It is incompatible with ototoxic antibiotics (streptomycin, neomycin, biomycin, amikacin, kanamycin) because it can mask the symptoms of ototoxicity and contribute to permanent hearing loss.

Special Instructions

The ability to affect reaction rate when driving motor vehicles or operating other mechanisms:

In view of the side effects, caution should be exercised when engaging in potentially hazardous activities requiring increased attention and rapid psychomotor reactions (including driving).

Contraindications

Hypersensitivity to the ingredients of the drug, epilepsy, acute exudative and vesicular dermatoses, children under 3 years of age, pregnancy, lactation.

With caution:

Convulsive syndrome, closed-angle glaucoma, prostatic hyperplasia, bronchial asthma, cardiovascular disease, hyperthyroidism, stenotic peptic ulcer, pyloroduodenal obstruction and bladder cervical obstruction.

Side effects

Periodicity of adverse events: very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000), unspecified frequency.

Disorders of the blood and lymphatic system:

Very rarely: hemolytic anemia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, or pancytopenia.

Disorders of the immune system:

Rarely: anaphylactic shock.

Mental disorders:

Often: mood changes, anxiety, stiffness of movements.

Infrequent: insomnia.

Nervous system disorders:

Often: drowsiness.

Infrequent: impaired sense of balance, impaired concentration and memory impairment (more common in elderly patients), tremor, lack of coordination, confusion, hallucinations.

Rarely: headache, sleep disturbance, dizziness, orthostatic hypotension.

Very rare: paradoxical CNS stimulation (especially in children).

Visual impairment:

Rarely: glaucoma, vision problems (dilated pupil, blurred vision or double vision).

Hearing and labyrinth disorders:

Rarely: tinnitus.

Heart disorders:

Rarely: palpitations, tachycardia and hypotension.

Respiratory system, chest and mediastinum disorders:

Often: nasal congestion.

Gastrointestinal disorders:

Often: dry mouth, constipation, diarrhea, nausea, abdominal pain.

Liver and biliary tract disorders:

Unspecified frequency: impaired liver function (cholestatic jaundice).

Skin and subcutaneous tissue disorders:

Rarely: rash, redness.

Renal and urinary tract disorders:

Often: urinary disorders (urinary retention due to anticholinergic action).

General disorders and disorders at the site of administration:

Rarely: edema (less commonly, Quincke’s edema).

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms of overdose: dry mouth, nose and throat, red face, slow and difficult breathing, confusion, in children – seizures, hallucinations.

In case of appearance of these symptoms you should seek medical attention urgently.

Treatment: gastric lavage with activated charcoal suspension (20-30 g), administration of saline laxative (10-15 g of sodium sulfate), symptomatic therapy, with convulsions in children – phenobarbital (5-6 mg / kg), diazepam.

Pregnancy use

It is contraindicated (I trimester of pregnancy). Possible with special caution (II-III trimester) if the expected effect of therapy exceeds the potential risk to the fetus.

Breastfeeding should be stopped during treatment.

Similarities