Vertran pills 24mg, 30pcs

Composition

1 tablet contains:  active substance:  

• betahistine dihydrochloride 8 mg,16 mg or 24 mg;

excipients:

• microcrystalline cellulose- 151,810 / 303,619 / 455,430 mg,
• mannitol – 54,040 / 108,081 / 162,120 mg,
• citric acid monohydrate – 4,70 / 9,40 / 14,10 mg,
• colloidal silicon dioxide- 4,70 / 9,40 / 14,10 mg,
• talc – 11,75 / 23,50 / 35,25 mg

Pharmacological action

Pharmacodynamics

Agonist of H1-histamine receptors of the inner ear vessels and antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS).

It does not affect H2-histamine receptors, which improves blood circulation in the vascular strip of the inner ear due to the relaxing effect on the precapillary sphincters of the cochlea and labyrinth. Relieves symptoms of Meniere’s syndrome and vertigo.

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed in the gastrointestinal tract. Plasma protein binding is low (less than 5%). The maximum concentration in blood plasma (Cmax) is reached after 1 h.

When taking the drug with food, the maximum concentration of the drug in the blood is lower than when taken on an empty stomach, however, the total absorption of betahistine is the same in both cases, which indicates that food intake only slows down the absorption of betahistine.

It is metabolized in the liver to form an inactive metabolite of 2-pyridylacetic acid. Almost completely (90.7%) is excreted by the kidneys as a metabolite (2-pyridylacetic acid) within 24 hours. The elimination half-life is 3-4 hours. The rate of elimination remains constant, indicating a linear pharmacokinetics of betahistine.

Indications

Meniere’s syndrome, characterized by the following main symptoms: :

• dizziness (accompanied by nausea/vomiting)
• hearing loss
• tinnitus

Symptomatic treatment and prevention of vestibular vertigo (vertigo) of various etiologies.

Use during pregnancy and lactation

Taking betahistine during pregnancy and lactation is contraindicated, since there is insufficient data on its safety during pregnancy and lactation.

Contraindications

Hypersensitivity to any of the components of the drug. Due to insufficient data on efficacy and safety: pregnancy and lactation; age up to 18 years.

With caution

Betahistine should be used with caution in the treatment of patients with a history of gastric and duodenal ulcers. Patients with pheochromocytoma and bronchial asthma should be regularly monitored by a doctor during treatment.

Side effects

From the gastrointestinal tract: often (from >1/100 to >Nervous system disorders: common (>1/100 to >In addition to these effects identified in clinical trials, the following side effects have been reported in post-marketing use and in the scientific literature (the available data are insufficient to estimate their frequency): : From the gastrointestinal tract: moderate disorders, such as vomiting, pain in the gastrointestinal tract, bloating. As a rule, these effects disappear if you take the drug simultaneously with food or after reducing the dose. Skin and subcutaneous fat disorders: angioedema, urticaria, pruritus and rash. Immune system disorders: hypersensitivity reactions, including anaphylactic reactions reported.

Interaction

In vivo studies aimed at studying the interaction with other drugs have not been conducted. Based on in vitro data, it can be assumed that the activity of cytochrome P450 isoenzymes is not inhibited. When used concomitantly with H1-histamine receptor blockers, the therapeutic effect of betahistine may decrease.

How to take, course of use and dosage

Inside, while eating. The dose of the drug is:

• 8 mg tablets: 1-2 tablets 3 times a day.
• Tablets 16 mg: 1/2-1 tablet 3 times a day.
• Tablets 24 mg: 1 tablet 2 times a day.

The maximum daily dose is 48 mg. The dose and duration of treatment should be selected individually, depending on the patient’s response to treatment. Improvement is usually noted at the beginning of therapy, but it can be gradual and manifest itself even after a few weeks of treatment. In some cases, a stable therapeutic effect is achieved after several months of treatment. No dose adjustment is required in elderly patients, as well as in patients with renal and/or hepatic insufficiency.

Overdose

Symptoms: after taking the drug in doses up to 640 mg, mild to moderate symptoms (nausea, drowsiness, abdominal pain) may occur.

More serious complications (for example, seizures, cardiopulmonary complications) may occur when taking increased doses of betahistine, especially in combination with other medications.

Treatment: symptomatic.

Patients with pheochromocytoma should use the drug under the supervision of a doctor.

Special instructions

Effects on the ability to drive vehicles and mechanisms According to the results of clinical studies, it is believed that the effect of betahistine on the ability to drive a car and other mechanisms is absent or insignificant, since no effects potentially affecting this ability have been found.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Betahistine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, For adults

Indications

Cerebrovascular accident, Meniere ‘s Disease