Betahistine dihydrochloride.
Each tablet contains 24 mg betahistine dihydrochloride.
Pharmacology: Pharmacodynamics: Betahistine dihydrochloride is a specific histamine agonist with virtually no H2-activity. It appears to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.
Pharmacokinetics: Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is excreted almost quantitatively in urine as 2-pyridylacetic acid within 24 hours after administration. No unchanged betahistine has been detected.
Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting); hearing loss (hardness of hearing); tinnitus (ringing in the ear).
Symptomatic treatment of vestibular vertigo.
Adults (including the elderly): 8-16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.
Pediatric population: Betahistine is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
Geriatric population: No dose adjustment is required in elderly.
Renal impairment: No dose adjustment is required in renal impaired patients.
Hepatic impairment: No dose adjustment is required in hepatic impaired patients.
Mild to moderate symptoms are experienced with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.
Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.
Caution is advised in the treatment of patients with a clinical history of peptic ulcer. Phaeochromocytoma and bronchial asthma may show intolerance in patients. These patients need to be carefully monitored during the therapy.
There are no adequate data from the use of betahistine in pregnant women.
Betahistine should not be used during pregnancy unless clearly necessary.
It is not known whether betahistine is excreted in human milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
Immune System disorders: Hypersensitivity reactions, e.g. anaphylaxis have been reported.
Gastrointestinal disorders: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Nervous System disorders: Headache.
Skin and subcutaneous tissue disorders: Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.
Although an antagonism between betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.
Store below 30°C.
Shelf Life: 3 years.
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
Betanor tab 24 mg
5 × 10's
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