Betaserc tablets 16mg №15×2

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Betaserc tab 16mg in bl. in pack. No. 15×2
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Round biconvex tablets of white or almost white color with bevelled edges, with a risk on one side of the tablet and engraving “267” on both sides of the risk. The tablet is divided into two equal halves. The main active substance Betahistine Release form Tablets Dosage 16 mg Pharmacological action Pharmacodynamics Mechanism of action The mechanism of action of betahistine is partially known. There are several reliable hypotheses, confirmed by studies conducted with the participation of animals and humans: Betahistine has an effect on the histamine system Betahistine is both a partial agonist of H1-histamine receptors, as well as an antagonist of H3-receptors in the nervous tissue. It also has little effect on the activity of H2 receptors. Betahistine accelerates the metabolism and release of histamine by blocking presynaptic H3 receptors and the feedback system. Betahistine may improve cochlear circulation as well as cerebral circulation Pharmacological studies in animals indicate an improvement in blood supply to the vascular streaks of the inner ear, probably as a result of expansion of the precapillary sphincters in the microvasculature of the inner ear. Betahistine also enhances cerebral circulation in humans. Betahistine enhances vestibular compensation Betahistine accelerates the recovery of normal vestibular function after unilateral neurectomy in animals by stimulating and improving compensation from the central vestibular apparatus. This effect occurs due to an increase in the metabolism and release of histamine as a result of an antagonistic effect on HC receptors. In patients treated with betahistine, the recovery time of the function of the vestibular root after its injury was also reduced. Betahistine modifies the formation of impulses in the vestibular nuclei A dose-dependent inhibitory effect of betahistine on the formation of an action potential in neurons of the lateral and medial vestibular nuclei has also been established. Betahistine has no sedative properties. In animal studies, it has been proven that the pharmacodynamic properties of betahistine can have a beneficial therapeutic effect on the vestibular apparatus. Efficacy and clinical safety The efficacy of betahistine has been proven in studies involving patients with vertigo of vestibular origin and Meniere’s syndrome, who experienced an improvement in the condition associated with a decrease in the intensity and frequency of vertigo. Pharmacokinetics Absorption After oral administration, betahistine is rapidly and almost completely absorbed from all parts of the gastrointestinal tract. After absorption, it is rapidly and almost completely biotransformed to 2-pyridylacetic acid (2-PAA). The plasma concentration of betahistine is very low. For this reason, pharmacokinetic analyzes are based on the measurement of 2-PAA concentration in plasma and urine. Cmax in the case of taking the drug during meals is lower than when taken on an empty stomach. However, the complete absorption of betahistine is similar in both cases, indicating that food slows the absorption of betahistine. Distribution The level of betahistine associated with plasma proteins is less than 5%. Biotransformation After absorption, betahistine is rapidly and almost completely biotransformed to 2-PAA acid, which has no pharmacological activity. Following oral administration of betahistine, plasma (and urinary) concentrations of 2-PAA peak after 1 hour and decrease with an elimination half-life of about 3.5 hours. Excretion 2-PAA is rapidly excreted in the urine. When taking the drug at a dose of 8-48 mg, about 85% of the initial dose is excreted in the urine. Excretion of betahistine itself with feces or urine is negligible. The level of excretion when taken in the dose range from 8 mg to 48 mg is constant, indicating a linear pharmacokinetics of betahistine and indicating that the metabolic pathway remains unsaturated. Indications for use Symptomatic treatment of recurrent vertigo with or without cochlear symptoms. Dosage and administration Dosage Betaserc 8 mg The usual dosage for adults is 1-2 tablets 3 times a day, but not more than 6 tablets, i.e. 48 mg betahistine per day. Betaserc 16 mg The usual dosage for adults is 1/2-1 tablet 3 times a day. Betaserc 24 mg This dosage form is intended for use in patients requiring a daily dose of 48 mg betahistine. In other cases, lower doses should be used. The usual dosage for adults is 1 tablet 2 times a day. Children and adolescents Betaserc is not recommended for use in children and adolescents under the age of 18 due to insufficient data on efficacy and safety. Elderly patients Betahistine should be used with caution in elderly patients because the available safety data are limited. Renal insufficiency There are no data on the use in patients with renal insufficiency. Hepatic insufficiency There are no data on the use in patients with hepatic insufficiency. Duration of treatment The recommended duration of treatment is 2 to 3 months, treatment can be extended depending on the course of the disease, intermittent or continuous courses. How to use Inside, during meals, swallow the tablets without chewing, drinking a glass of water. Use during pregnancy and lactation Pregnancy Studies in animals have not shown any teratogenic effect. Since reproductive toxicity studies in animals do not always allow the assessment of the possibility of toxic effects on pregnancy, embryo / fetus development, childbirth and postnatal development in humans, it is not recommended to take betahistine during pregnancy. Breast-feeding period It is not known whether betahistine is excreted in breast milk. Betahistine is excreted in the milk of rats. Effects in the postpartum period in animal studies were observed only at very high doses. The benefit of the drug to the mother should be weighed against the benefits of breastfeeding and the potential risk to the baby. Fertility Animal studies have shown no effect on fertility in rats. Precautions Patients with bronchial asthma require careful monitoring during therapy with betahistine (risk of bronchospasm). Taking the drug with meals can prevent pain in the stomach. Betahistine is not recommended for the treatment of the following pathological conditions: benign paroxysmal dizziness; dizziness associated with damage to the central nervous system. Interaction with other drugs In vivo studies on drug interactions have not been conducted. The data obtained in studies in vitro do not give grounds to assume inhibition of the activity of cytochrome P45O enzymes in vivo. Laboratory data in vitro indicate the possibility of inhibition of the biotransformation of betahistine by monoamine oxidase inhibitors (MAOIs), including MAO subtype B (for example, selegiline). Caution is advised when taking betahistine and MAO inhibitors (including selective MAO-B inhibitors) at the same time. Because betahistine is a histamine analog, the interaction of betahistine with antihistamine drugs could theoretically affect the effectiveness of one of them. Contraindications Hypersensitivity to any component of the drug; Active phase of peptic ulcer; Pheochromocytoma. Composition 1 tablet 16 mg contains: 16 mg betahistine dihydrochloride, which corresponds to 10.42 mg betahistine; Excipients: microcrystalline cellulose, mannitol (E421), citric acid monohydrate, anhydrous colloidal silicon dioxide, talc. Overdose There are reports of several cases of drug overdose. Some patients have experienced mild or moderate symptoms after taking the drug at a dose of up to 640 mg (for example, nausea, drowsiness, abdominal pain). More serious overdose symptoms (eg, convulsions, pulmonary or cardiovascular complications) have been observed with the deliberate intake of high doses of betahistine in combination with an overdose of other drugs. Treatment of symptoms of overdose is carried out using the usual corrective measures. Side effects The following adverse reactions were observed in patients taking betahistine during clinical placebo-controlled studies, with the following frequency: very often (≥1 / 10); often (≥1/100 to <1/10); not often (≥1/1000 to <1/100); rarely (≥1/10000 to <1/1000); very rarely (<1/10000). Gastrointestinal disorders Common: Nausea and dyspepsia. Nervous system disorders Common: headache. In addition to the reactions observed during clinical trials, the following adverse reactions have also been spontaneously reported during post-marketing use of the drug and in the scientific literature. Their frequency cannot be estimated from the available data (frequency unknown). Blood and lymph system disorders: Thrombocytopenia Immune system disorders: Hypersensitivity reactions (cases of anaphylaxis have been reported) Gastrointestinal disorders: Minor mild gastrointestinal disorders (such as gastralgia, vomiting, dry mouth, diarrhoea, abdominal pain, bloating and flatulence). These side effects usually disappear when the drug is taken with food or after a dose reduction. Skin and subcutaneous tissue disorders: Skin and subcutaneous tissue hypersensitivity reactions have been observed, in particular angioedema, urticaria, rash and itching. Storage conditionsStore in the original packaging at a temperature not exceeding 25°C. Keep out of the reach of children. 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