Aviamarin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

R06AX (Other systemic antihistamines)

Active Substance

Dimenhydrinate (Rec.INN registered by WHO)

Dosage Form

Aviamarin®

Tablets 50 mg: 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical in shape with a bevel and a score line.

Excipients: microcrystalline cellulose, povidone (kollidon 30), crospovidone, mannitol, colloidal silicon dioxide (aerosil), magnesium stearate.

5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Drug used for vestibular apparatus pathology

Pharmacotherapeutic Group

H1 histamine receptor blocker

Pharmacological Action

It blocks histamine H₁ receptors and m-cholinergic receptors of the CNS. It depresses the vestibular apparatus of the inner ear, acting primarily on the otoliths, and in high doses, on the semicircular canals. It has antiemetic, anorexigenic, and sedative effects, and relieves dizziness.

Pharmacokinetics

Absorption and Distribution

After oral administration, Dimenhydrinate is well absorbed and distributed throughout organs and tissues. The drug’s effect appears within 15-30 minutes and lasts for 3-6 hours. About 78% of dimenhydrinate binds to plasma proteins.

Metabolism and Excretion

Dimenhydrinate is metabolized in the liver and is almost completely eliminated from the body with urine within 24 hours. Small amounts are excreted in breast milk. The T_1/2 of dimenhydrinate is about 3.5 hours.

Indications

• Motion sickness (seasickness, carsickness, and airsickness);
• Prevention and treatment of symptoms of vestibular and labyrinthine disorders (dizziness, nausea, vomiting), except for symptoms caused by anticancer therapy;
• Ménière’s disease.

ICD codes

Dosage Regimen

Orally, before meals.

Motion sickness (seasickness, carsickness, and airsickness)

Children aged 3 to 6 years 1/4-1/2 tablet 2-3 times/day.

Children aged 7-12 years 1/2-1 tablet 2-3 times/day.

Children over 12 years and adults: 1-2 tablets 2-3 times/day.

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

Children aged 3 to 6 years 1/4-1/2 tablet 2-3 times/day.

Children aged 7-12 years 1/2-1 tablet 2-3 times/day.

Children over 12 years and adults: 1-2 tablets 2-3 times/day.

Ménière’s disease

Children aged 3 to 12 years 1/2-1 tablet 2-3 times/day.

Children over 12 years and adults: 1-2 tablets 2-3 times/day.

The maximum daily dose for adults should not exceed 7 tablets.

For the prevention of motion sickness, 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 should be agreed with the doctor.

Adverse Reactions

Definition of frequency categories of adverse reactions: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000), frequency not known.

Blood and lymphatic system disorders very rare – hemolytic anemia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia or pancytopenia.

Immune system disorders rare – anaphylactic shock.

Psychiatric disorders common – mood changes, anxiety, motor stiffness; uncommon – insomnia.

Nervous system disorders: common – drowsiness; uncommon – impaired sense of balance, impaired concentration and memory (more often in elderly patients), tremor, lack of coordination, confusion, hallucinations; rare – headache, sleep disorder, dizziness, orthostatic hypotension; very rare – paradoxical CNS stimulation (especially in children).

Eye disorders rare – glaucoma, vision problems (pupil dilation, blurred vision or double vision).

Ear and labyrinth disorders rare – ringing in the ears.

Cardiac disorders: rare – palpitations, tachycardia and hypotension.

Respiratory, thoracic and mediastinal disorders: common – nasal congestion.

Gastrointestinal disorders: common – dry mouth, constipation, diarrhea, nausea, abdominal pain.

Hepatobiliary disorders frequency not known – impaired liver function (cholestatic jaundice).

Skin and subcutaneous tissue disorders: rare – rash, redness.

Renal and urinary disorders: common – urination disorder (urinary retention due to anticholinergic action).

General disorders and administration site conditions: rare – edema (less commonly – angioedema).

If any of the side effects mentioned in the instructions get worse, or the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Epilepsy;
• Acute exudative and vesicular dermatoses;
• Children under 3 years of age;
• First trimester of pregnancy;
• Breastfeeding period.

With caution

Convulsive syndrome, closed-angle glaucoma, prostatic hyperplasia, bronchial asthma, cardiovascular diseases, hyperthyroidism, stenosing peptic ulcer, pyloroduodenal obstruction and obstruction of the bladder neck.

Use in Pregnancy and Lactation

Use of the drug in the second and third trimesters of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Use of the drug in the first trimester of pregnancy and during breastfeeding is contraindicated.

Breastfeeding should be discontinued during treatment.

Pediatric Use

Contraindication: children under 3 years of age.

Special Precautions

Effect on the ability to drive vehicles and machinery

Considering the side effects of dimenhydrinate, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions (including driving).

Overdose

Symptoms of overdose: dry mouth, nose, and throat, facial flushing, slow and difficult breathing, confusion, in children – convulsions, hallucinations. If these symptoms appear, it is necessary to consult a doctor urgently.

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

Drug Interactions

Dimenhydrinate enhances the effects of atropine, tricyclic antidepressants, catecholamines, barbiturates, ethanol, sedatives and hypnotics, neuroleptics.

Dimenhydrinate weakens the effect of corticosteroids, anticoagulants.

Dimenhydrinate reduces the response to apomorphine.

Dimenhydrinate reduces the depressive effect of acetylcholine on the heart muscle.

Combination with bismuth preparations, scopolamine, analgesics and psychotropic drugs increases the likelihood of visual impairment.

Incompatible with ototoxic antibiotics (streptomycin, neomycin, biomycin, amikacin, kanamycin), because Dimenhydrinate may mask the symptoms of ototoxicity and contribute to the development of irreversible hearing impairment.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.