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Indications and Dosage
Oral
Meniere's disease Adult: For vertigo, tinnitus and hearing loss associated in patients with Meniere’s disease: As betahistine dihydrochloride: Initially, 8-16 mg tid or 24 mg bid, adjusted according to individual response. Maintenance: 24-48 mg daily. Max: 48 mg daily. As betahistine mesilate: 6-12 mg tid.
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Administration
May be taken with or without food.
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Contraindications
Phaeochromocytoma.
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Special Precautions
Patients with bronchial asthma, CV disease, active or history of peptic ulcer disease. Hepatic impairment. Pregnancy and lactation.
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Adverse Reactions
Significant: Rarely, ventricular extrasystoles, hypotension (including orthostatic hypotension), tachycardia.
Gastrointestinal disorders: Nausea, dyspepsia. Rarely, vomiting, bloating, abdominal distension or pain. General disorders and admin site conditions: Rarely, fatigue, malaise. Immune system disorders: Hypersensitivity reactions (e.g. anaphylaxis). Rarely, urticaria. Nervous system disorders: Headache. Rarely, dizziness, convulsions, somnolence. Psychiatric disorders: Rarely, confusion, hallucination. Respiratory, thoracic and mediastinal disorders: Rarely, dyspnoea, bronchospasm. Skin and subcutaneous tissue disorders: Rarely, rash, pruritus. Vascular disorders: Rarely, vasodilation. |
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Overdosage
Symptoms: Nausea, somnolence, abdominal pain, convulsion, pulmonary or cardiac complications. Management: Supportive treatment.
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Drug Interactions
Serum concentration may be increased by MAOIs (e.g. selegiline). Therapeutic effects may be decreased by antihistamines. May decrease the bronchodilator effects of β2 agonists.
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Food Interaction
Delayed absorption with food.
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Action
Description: Betahistine is a histamine analogue. The exact mechanism is not yet fully determined; however, it is known to act as both partial histamine H1-receptor agonist and histamine H3-receptor antagonist in neuronal tissue, with negligible histamine H2-receptor activity. It may also improve the microcirculation in the labyrinth, thus reducing endolymphatic pressure.
Pharmacokinetics: Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Delayed absorption with food. Time to peak plasma concentration: 1 hour (2-pyridylacetic acid). Distribution: Plasma protein binding: <5%. Metabolism: Rapidly and almost completely metabolised in the liver to its inactive metabolite, 2-pyridylacetic acid. Excretion: Via urine (Approx 91%, mainly as inactive metabolite). Elimination half-life: Approx 3.5 hours (2-pyridylacetic acid). |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. Betahistine, CID=2366, https://pubchem.ncbi.nlm.nih.gov/compound/Betahistine (accessed on Jan. 21, 2020) |
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Storage
Store below 25°C. Protect from moisture and light.
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MIMS Class
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ATC Classification
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
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References
Anon. Betahistine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/09/2019. Buckingham R (ed). Betahistine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Joint Formulary Committee. Betahistine Dihydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/09/2019. Merislon Tablets (Eisai Co., Ltd. Kawashima Plant). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 24/09/2019. Mylan New Zealand Ltd. Vergo 16 Tablet data sheet 15 May 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 13/09/2019.
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