Brand name: Betaserc

Active ingredient (generic name): Betahistine

Manufacturer: Solvay

Importer: Behestan Darou

Pharmacotherapeutic group: histamine agonist

Pharmaceutical form: 8mg & 16mg tablets

Pharmacodynamic:  

The mechanism of action of betahistine is not known. Pharmalogical testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of relaxarion of the precapillary sphincters of the microcirculation of the inner ear.

 

Pharmacokinetic:

Betahistine dihydrochloride is completely absorbed after oral administration. Only one metabolite, 2-pyridylacetic acid which is excreted in the urine, is known.

 

Therapeutic indication:

It is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

 

Dosage and administration:

The dosage for adults is 24-28 mg divided over the day. The dosage should be individually adapted according to the response. There are indications that treatment from the onset of the disease and/or loss of the hearing in later phases of the disease.

 

 

 

Adverse reaction:

The following undesirable effects have been experienced nausea, dyspepsia, vomiting, gastrointestinal pain, abdominal distension, bloating, angioneurotic oedema, urticaria, rash, and pruritus. These can normally be dealt with by taking the dose during meals or by lowering the dose.

 

 

Contraindication:

Hypersensitivity to the active substance or to any of the excipients

Special warnings:

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

 

Pregnancy and lactation:

Pregnancy category is C. It can be administered after careful assessment of the benefits against possible risks by the physician.

 

Storage temperature:  

Room temperature (15-25 C)

 

 

 

 

 

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