Betahistine


Concise Prescribing Info
Indications/Uses
Meniere's disease.
Dosage/Direction for Use
Adult : PO For vertigo, tinnitus and hearing loss associated in patients with Meniere’s disease: As betahistine dihydrochloride: Initial: 8-16 mg tid or 24 mg bid, adjusted according to individual response. Maintenance dose: 24-48 mg/day. Max: 48 mg/day. As betahistine mesilate: 6-12 mg tid.
Dosage Details
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.
Administration
May be taken with or without food.
Contraindications
Phaeochromocytoma.
Special Precautions
Patients with bronchial asthma, CV disease, active or history of peptic ulcer disease. Hepatic impairment. Pregnancy and lactation.
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.
Overdosage
Symptoms: Nausea, somnolence, abdominal pain, convulsion, pulmonary or cardiac complications. Management: Supportive treatment.
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.
Food Interaction
Delayed absorption with food.
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).
Chemical Structure

Chemical Structure Image
Betahistine

Source: National Center for Biotechnology Information. PubChem Database. Betahistine, CID=2366, https://pubchem.ncbi.nlm.nih.gov/compound/Betahistine (accessed on Jan. 21, 2020)

Storage
Store below 25°C. Protect from moisture and light.
MIMS Class
ATC Classification
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
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.

Disclaimer: This information is independently developed by MIMS based on Betahistine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Merislon
  • Serc
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in