Betahistine is indicated for the treatment of Ménière’s syndrome, which may include symptoms such as vertigo, tinnitus, hearing loss, and nausea.
Adults:The initial oral dose is 8 to 16 mg three times daily, preferably taken with meals.
Maintenance doses generally range from 24 to 48 mg per day, with a maximum daily dose of 48 mg.
Dosage should be adjusted based on individual patient needs.
Improvement may only become noticeable after a few weeks of treatment.
Hepatic impairment: No available data.
Renal impairment: No available data.
Elderly patients: Limited data; use with caution.
Children & Adolescents: Not recommended for individuals under 18 years of age due to a lack of safety and efficacy data.
Betahistine is contraindicated in patients with:
Phaeochromocytoma (as it may trigger the release of catecholamines, causing severe hypertension).
Hypersensitivity to betahistine or any of its components.
Peptic Ulcer Disease: Use with caution in patients with an active or past history of peptic ulcer, as dyspepsia may occur.
Bronchial Asthma: Exercise caution in patients with asthma.
Allergic Conditions: Patients with urticaria, rashes, or allergic rhinitis should be monitored, as symptoms may worsen.
Severe Hypotension: Betahistine should be used cautiously in patients with severe low blood pressure.
Lactose Intolerance: Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication.
Rare cases of drowsiness have been reported. If affected, patients should avoid driving or operating heavy machinery.
There are no proven hazardous interactions.
Cases of interaction with ethanol and pyrimethamine-dapsone combinations have been reported.
Betahistine is a histamine analogue, so concurrent use with H1 antagonists (antihistamines) may reduce the efficacy of both drugs.
Pregnancy: Limited data is available. While animal studies do not indicate harmful effects, betahistine should only be used if absolutely necessary.
Lactation: There is insufficient data on excretion in breast milk, so it is recommended to avoid betahistine during breastfeeding.
Immune System Disorders:Very rare (<1/10,000): Skin rashes and itching (pruritus).
Nervous System Disorders:Unknown frequency: Headache and occasional drowsiness.
Gastrointestinal Disorders:Rare (>1/10,000, <1/1,000): Nausea, dyspepsia, and gastrointestinal discomfort.
Cardiac Disorders:Rare (>1/10,000, <1/1,000): Palpitations.
Skin & Subcutaneous Tissue Disorders:Rare (>1/10,000, <1/1,000): Urticaria (hives).
Symptoms of betahistine overdose include:
Nausea, vomiting, dyspepsia, ataxia, and seizures.
Severe cases (especially with multiple drug overdoses) may lead to convulsions, pulmonary complications, or cardiac issues.
No specific antidote is available.
Gastric lavage and symptomatic treatment are recommended.
Store at a temperature not exceeding 30°C.
Keep in a dry place, protected from light and moisture.
Medicine: Keep out of reach of children.