Betahistine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of betahistine.
Drugs List
Therapeutic Indications
Uses
Meniere's disease
Dosage
Adults
Initially 8 to 16mg three times daily, preferably with meals.
Maintenance doses are generally within the range 24 to 48mg daily.
Dosage should be adjusted to suit individual needs, and sometimes improvement can only be seen after a couple weeks of treatment.
Contraindications
Children under 18 years
Phaeochromocytoma
Precautions and Warnings
Allergic rhinitis
Asthma
Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
History of peptic ulcer
History of urticaria
Lactose intolerance
Porphyria
Pregnancy
Severe hypotension
Some formulations contain lactose
Monitor patients with bronchial asthma
Caution is advised in patients with a history of peptic ulceration due to the occasional occurrence of dyspepsia experienced by patients taking betahistine.
Patients with urticaria, rashes or allergic rhinitis are at risk of exacerbating these symptoms when taking betahistine.
Pregnancy and Lactation
Pregnancy
Use betahistine with caution during pregnancy.
Betahistine should not be used during pregnancy unless clearly necessary. There are limited data on the use of betahistine in pregnant women, and animal studies are insufficient with respect to its effects on pregnancy, embryonal/foetal development, parturition and postnatal development.
The use of betahistine does not justify a risk-based termination of the pregnancy (Schaefer, 2015).
Lactation
Use betahistine with caution during breastfeeding.
It is not known whether betahistine is excreted in human milk. There are limited animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
Hale (2014) suggests that alternatives to betahistine should be used where available due to the risk of side effects in the nursing infant.
Side Effects
Abdominal distension
Anaphylaxis
Angioneurotic oedema
Bloating
Bronchospasm
Drowsiness
Dyspepsia
Gastro-intestinal pain
Headache
Hypersensitivity reactions
Nausea
Palpitations
Pruritus
Rash
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Further Information
Last Full Review Date: November 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Betahistine 8 mg tablets. Aurobindo Pharma - Milpharm Ltd. Revised August 2014.
Summary of Product Characteristics: Betahistine 16 mg tablets. Aurobindo Pharma - Milpharm Ltd. Revised August 2014.
Summary of Product Characteristics: Betahistine Dihydrochloride 8 mg tablets. Accord Healthcare Limited. Revised September 2015.
Summary of Product Characteristics: Betahistine Dihydrochloride 16 mg tablets. Accord Healthcare Limited. Revised September 2015.
Summary of Product Characteristics: Betahistine Dihydrochloride 8 mg tablets. Kent Pharmaceuticals Ltd. Revised September 2014.
Summary of Product Characteristics: Betahistine Dihydrochloride 16 mg tablets. Kent Pharmaceuticals Ltd. Revised September 2014.
Summary of Product Characteristics: Betahistine Dihydrochloride 24 mg tablets. Medreich PLC. Revised September 2020.
Summary of Product Characteristics: Serc-8. Mylan Products Limited. Revised September 2016.
Summary of Product Characteristics: Serc-16. Mylan Products Limited. Revised September 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 July 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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