Betatin 16 mg (Tablet)

Indications

• Meniere's disease and Meniere-like syndromes are characterized by attacks of vertigo
• tinnitus and/or progressive loss of hearing
• usually accompanied by nausea and vomiting

Description

• Betatin is a histamine analog
• developed following successful parenteral use of histamine in patients
• relieves vertigo symptoms by improving circulation in the microvasculature of the inner ear
• leads to a pressure reduction on the membranous labyrinth and relieves the symptoms of Meniere's disease

Pharmacology

• Betahistine acts as a histamine H1-receptor agonist
• causes a vasodilatory effect leading to increased permeability of blood vessels
• reduction in endolymphatic pressure
• reducing the asymmetrical functioning of sensory vestibular organs
• increasing vestibulocochlear blood flow
• H3-receptor antagonism elevates levels of neurotransmitters including serotonin in the brainstem

Dosage & Administration

• Initial oral treatment is 8 to 16mg three times daily
• taken preferably with meals
• Maintenance doses are generally in the range 24-48 mg daily
• Daily dose should not exceed 48mg
• Dosage can be adjusted to suit individual patient needs
• There is no data available for patients with hepatic impairment
• There is limited data in the elderly

Interaction

• No proven cases of hazardous interactions
• Ethanol
• pyrimethamine with dapsone
• potentiation of betahistine with salbutamol
• concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents

Contraindications

• Patients with phaeochromocytoma
• Hypersensitivity to the active substance

Side Effects

• Generally well tolerated
• No known serious adverse effects
• gastrointestinal disturbances
• headache
• rashes
• pruritus

Pregnancy & Lactation

• The safety of Betahistine in human pregnancy has not been completely established
• no known teratogenic effect in animals
• Betahistine is excreted in the breast milk of nursing mothers
• toxicity to the neonate at these concentrations is not known

Precautions & Warnings

• treatment of patients with peptic ulcer or a history of peptic ulceration
• patients with bronchial asthma
• patients with either urticaria, rashes or allergic rhinitis
• severe hypotension
• hereditary problems of galactose intolerance
• the Lapp lactase deficiency or glucose-galactose malabsorption
• Rare reports of drowsiness associated with betahistine
• avoid activities requiring concentration, such as driving and operating machinery

Overdose Effects

• nausea
• vomiting
• dyspepsia
• ataxia
• seizures
• convulsion
• pulmonary or cardiac complications
• No specific antidote
• Gastric lavage and symptomatic treatment are recommended

Therapeutic Class

• Drugs used in Meniere's diseases

Storage Conditions

• Keep below 30°C temperature
• away from light & moisture
• Keep out of the reach of children

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