Betahistine hydrochloride.
Each film-coated tablet contains: Betahistine hydrochloride 8 mg and 16 mg.
Each tablet contains: Betahistine hydrochloride 24 mg.
Pharmacology: The mechanism of action of betahistine hydrochloride is not known. Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improved, due to relaxation of the precapillary sphincter of the microcirculation of the inner ear. In the pharmacological studies, betahistine hydrochloride was found to have weak H1-receptor agonist and considerable H3-antagonist properties in the CNS and automatic nervous system. Betahistine hydrochloride was found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of this observation in the action against Meniere's syndrome of vestibular vertigo, however, remains unclear.
Betahistine hydrochloride is completely absorbed after oral administration.
Only one metabolite, 2-pyridylactic acid which is excreted in urine is known.
Indicated in Meniere's disease, Meniere-like syndrome (with symptoms of vertigo, tinnitus, and sensorineural deafness) and vertigo of peripheral origin.
The dosage for adults is 24-48 mg given in 2 or 3 divided doses.
For 8 mg Film-Coated Tablet: 1-2 tablets 3 times a day preferably with food.
For 16 mg Film-Coated Tablet: ½-1 tablet 3 times a day preferably with food.
For 24 mg tablets: 1 tablet 2 times a day preferably with food.
Administration to children is not recommended.
The dosage should be individually adapted according to the response. Improvement can be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications for the treatment from the onset of the disease and/or the loss of hearing in later phases of the disease.
Hypersensitivity to the active substance or any of the excipients.
Betahistine should not be given to patients with pheochromocytoma. It should be given with care to patients with asthma, peptic ulcer disease, or a history of peptic ulcer disease.
Gastrointestinal disturbances, headache, skin rashes and pruritus.
Store at temperatures not exceeding 30°C.
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
Vert FC tab 16 mg
100's (P28.5/film-coated tab)
Vert FC tab 24 mg
100's (P48.5/film-coated tab)
Vert FC tab 8 mg
100's (P23/film-coated tab)