Betaserc

Betaserc

betahistine

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Betahistine diHCl.
Action
Pharmacology: The mechanism of action of betahistine is not known. Pharmacologic testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear.
In pharmacological studies, betahistine was found to have weak H1-receptor agonistic and considerable H3-antagonistic properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose-dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of these observations in the action against Meniere's syndrome or vestibular vertigo however, remains unclear.
Pharmacokinetics: Betahistine is completely absorbed after oral administration. Only 1 metabolite, 2-pyridylacetic acid, which is excreted in the urine, is known.
Indications/Uses
Treatment of Meniere's syndrome which is usually characterized by dizziness, tinnitus, nausea and headache. This is often accompanied by loss of hearing. Symptomatic treatment of vestibular vertigo.
Dosage/Direction for Use
Adults: 48 mg in divided doses daily. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.
Overdosage
A few cases of overdosage (up to 640 mg) have been reported. In one of the cases, nausea was observed.
Contraindications
Hypersensitivity to any component of Betaserc.
Special Precautions
Patients suffering from phaeochromocytoma and patients with bronchial asthma need to be carefully monitored during the therapy. Caution should be taken in the treatment of patients with a history of peptic ulcer.
Effects on the Ability to Drive or Operate Machinery: Research has shown that betahistine does not influence the ability to drive and to use machine.
Use in pregnancy & lactation: There is insufficient data on the use of betahistine during pregnancy to evaluate possible harmful effects. There are no indications for harmful effects in animal testing.
Use In Pregnancy & Lactation
There is insufficient data on the use of betahistine during pregnancy to evaluate possible harmful effects. There are no indications for harmful effects in animal testing.
Side Effects
In some cases, mild gastric complaints have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Drug Interactions
No interactions are known.
Incompatibilities: None known.
Storage
Store in a dry place at temperatures not below 0°C and preferably not above 25°C.
MIMS Class
ATC Classification
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
Presentation/Packing
Tab 24 mg x 50's.
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