Betahistine (Betaserc Long) XR 48 mg – [56 tablets]

Description

Betacerc Long Pharmacodynamics
The mechanism of action of betahistine is only partially known. There are several possible hypotheses supported by preclinical and clinical data:
– Effects on the histaminergic system.
Partial agonist of H1-histamine and antagonist of H3-histamine receptors of the vestibular nuclei of the CNS, has negligible activity against
H2-receptors. Betahistine increases histamine metabolism and release by blocking presynaptic H3 receptors and decreasing H3 receptors.
– Increased blood flow to the cochlear region as well as the entire brain
According to preclinical studies, betahistine improves blood flow in the inner ear vasculature by relaxing the precapillary sphincters of the inner ear vessels. Betahistine has also been shown to increase cerebral blood flow in humans.
– Facilitation of central vestibular compensation
Betahistine accelerates the recovery of vestibular function in animals after unilateral vestibular neurectomy by accelerating and facilitating central vestibular compensation through antagonism with H3-histamine receptors.
Recovery time after vestibular neurectomy in humans is also reduced by treatment with betahistine.
– Suppression of neuronal excitation in vestibular nuclei
Dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei.
The pharmacodynamic properties found in animals provide a positive therapeutic effect of betahistine in the vestibular system.
The efficacy of betahistine has been demonstrated in patients with vestibular vertigo and Meniere’s syndrome, as manifested by a reduction in the severity and frequency of vertigo.

Indications
Meniere’s syndrome, characterized by the following main symptoms:
– Dizziness (accompanied by nausea/vomiting)
– Decreased hearing (hearing loss)
– tinnitus
Symptomatic treatment of vestibular vertigo.

Contraindications
– Hypersensitivity to any component of the drug
– Lactose intolerance, lactase deficiency and glucose-galactose malabsorption due to the presence of lactose in the drug
– Pheochromocytoma
– Not recommended for use in children under 18 years of age in connection with insufficient data on efficacy and safety
Caution
Patients with bronchial asthma, peptic ulcer and/or duodenal ulcer require close monitoring during treatment.
Use during pregnancy and lactation
Pregnancy
There are insufficient data available on the use of betahistine in pregnant women.
Animal studies have shown no direct or indirect reproductive toxicity. Betahistine should not be used during pregnancy unless absolutely necessary.
Breastfeeding period
It is not known whether betahistine is excreted with breast milk in humans. Betahistine is excreted with breast milk in rats. Animal studies have been limited to the use of the drug at very high doses. Administration of the drug to the mother should be decided only after weighing the benefits of breastfeeding against the potential risks to the infant.
Fertility
No effect on fertility has been observed in animal studies (rats).

How to use and dosages.

• Inside. With meals.
• Betaserk® Long tablet cannot be divided into parts because it is coated with a film in order to allow gradual release of the active substance.
• The dose of Betaserk® Long for adults is:
  1 tablet daily in the morning.
• Older Adults
• Although clinical trial data are limited, extensive post-registration experience suggests that no dose adjustment is necessary in this patient group.
• Patients with renal/hepatic impairment
• Special clinical trials have not been conducted in this group of patients, but post-registration experience suggests that no dose adjustment is required in this patient group.