Betannorm (Tablets) Instructions for Use

ATC Code

N07CA01 (Betahistine)

Active Substance

Betahistine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug improving microcirculation of the labyrinth, used for pathology of the vestibular apparatus

Pharmacotherapeutic Group

Histamine preparation

Pharmacological Action

Synthetic analogue of histamine. It acts similarly to histamine, mainly on histamine H₁ receptors.

It causes dilation of precapillaries, in particular, facilitates microcirculation in the labyrinth.

Furthermore, Betahistine regulates endolymph pressure in the labyrinth and cochlea, leading to clinical improvement in vertigo of various etiologies.

It reduces the frequency and intensity of vertigo, decreases tinnitus, and contributes to hearing improvement in cases of its decline.

It increases the tone of the smooth muscles of the bronchi and gastrointestinal tract.

It may cause increased secretion of gastric juice.

Pharmacokinetics

After oral administration, betahistine dihydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract.

Plasma protein binding is low.

It is almost completely eliminated from the body with urine within 24 hours.

T_1/2 is 3-4 hours.

Indications

Meniere’s disease; syndromes characterized by vertigo, tinnitus and/or progressive hearing loss, including labyrinthine hydrops of the inner ear, vestibular and labyrinthine disorders (including dizziness, tinnitus and ear pain, headache, nausea, vomiting, hearing loss), vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations); vertebrobasilar insufficiency, post-traumatic encephalopathy, cerebral vascular atherosclerosis (as part of complex therapy).

ICD codes

Dosage Regimen

Administer the tablets orally.

Take a single dose of 8 mg to 16 mg.

Maintain a frequency of three times per day.

Initiate therapy at the lower end of the dosage range.

Titrate the dose based on individual patient response and tolerability.

For management of dyspeptic symptoms, take the tablets during or after meals.

Continue treatment long-term to achieve the desired clinical effect.

Be aware that the full therapeutic benefit may require several months of continuous therapy.

Do not exceed the maximum recommended daily dose.

Adverse Reactions

From the digestive system, mildly expressed nausea, feeling of heaviness in the epigastrium are possible.

Allergic reactions in individual cases – skin rash, itching, urticaria.

Contraindications

Hypersensitivity to betahistine, pheochromocytoma, gastric and duodenal ulcer in the acute phase, bronchial asthma, first trimester of pregnancy.

With caution second and third trimesters of pregnancy, period of breastfeeding; children.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy. It should be used with caution in the second and third trimesters of pregnancy. Use is not recommended during breastfeeding.

Pediatric Use

It should be used with caution in children.

Special Precautions

It should be used with caution in patients with a history of gastric or duodenal ulcer, in the second and third trimesters of pregnancy, and in children.

It is necessary to consider that the desired clinical effect is achieved after several months of treatment.

In case of dyspeptic symptoms, Betahistine is recommended to be taken during or after meals.

Drug Interactions

Antihistamine drugs with simultaneous administration reduce the effect of betahistine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.