Betahistine Dihydrochloride

Registered South African indications:

• Symptomatic treatment of vertigo associated with Ménière’s syndrome

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Active peptic ulcer
• Phaeochromocytoma

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Phaeochromocytoma

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• History of peptic ulcers
• Asthma
• Urticaria
• Rashes
• Allergic rhinitis
• Severe hypotension

Forms avail in SA and covered in this monograph: tab

South African registered indications and dosages

Symptomatic treatment of vertigo associated with Ménière’s syndrome

• Oral (tab): 24-48mg, daily in divided doses preferably with meals (the 24mg tab may be given twice daily)

The dosage should be individually adapted according to the response

Not recommended for use

Pregnancy

• Caution
• There is a very limited amount of data from the use of betahistine in pregnant women. Animal studies, though insufficient do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The potential risk for humans is unknown. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy

Breastfeeding

• Caution; not recommended
• There is insufficient information on the excretion of betahistine in human milk. There are no animal studies on the excretion of betahistine in milk. Betahistine should not be used during breastfeeding

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Headache
• Drowsiness

Cardiovascular Disorders

• Palpitations

Respiratory Disorders

• Bronchospasm

Gastrointestinal Disorders 

• Nausea and vomiting
• Dyspepsia
• Gastrointestinal pain
• Abdominal distension

Skin and Subcutaneous Tissue Disorders 

• Angioneurotic oedema
• Urticaria
• Rash
• Pruritus

Blood, Immune and Lymphatic System Disorders 

• Hypersensitivity reactions
• Anaphylaxis

• Alcohol
• Salbutamol
• Monoamine oxidase inhibitors
• H1 antagonists

None routine

Betahistine has an agonist effect on H1 receptors located on blood vessels in the inner ear. It acts on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space. It also has antagonistic effects at H3 receptors, which increases the levels of neurotransmitters released from the nerve endings. The increased amount of histamine released, stimulates H1 receptors, thus augmenting the direct agonistic effects of betahistine on these receptors.  

Tablet 24mg

• Dahide (Aurobindo)
• Hidrist (Aurobindo)
• Menivert (Pharmacare)
• Serc (Abbott) originator
• Trevigo (Novagen) 
• Vertin 24 (Abbott)