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Indications/Uses
It is used to reduce the symptoms of vertigo, tinnitus and hearing loss associated with Meniere's Disease.
Dosage/Direction for Use
Adults (including elderly): The usual initial adult dosage is 16 mg, three times daily, taken preferably with meal. Maintenance dose are generally in the range of 24-48 mg daily.
Pediatric Population: Not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Or as prescribed by the physician.
Pediatric Population: Not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Or as prescribed by the physician.
Overdosage
A few overdose cases (up to 640 mg) with mild to moderate symptoms of nausea, dry mouth, dyspepsia, abdominal pain and somnolence have been reported.
No specific antidote. Gastric lavage and symptomatic treatment is recommended.
No specific antidote. Gastric lavage and symptomatic treatment is recommended.
Administration
Should be taken with food.
Contraindications
In patients with known hypersensitivity to Betahistine or to any of the tablet constituents.
Phaeochromocytoma.
Phaeochromocytoma.
Special Precautions
Betahistine should not be given to patients with phaeochromocytoma.
Caution is advised in the treatment of patients with a history of peptic ulcer.
It should be given with care to patients with asthma.
Betahistine is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Caution is advised in the treatment of patients with a history of peptic ulcer.
It should be given with care to patients with asthma.
Betahistine is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category B.
The safety of Betahistine Hydrochloride in pregnancy has not been established. Therefore, its use in pregnancy or lactation, or in women of childbearing age requires that its potential benefits be weighed against the possible risks. This drug should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Betahistine is excreted in human milk; hence, its use in pregnancy or lactation, or in women with childbearing potential requires that the potential benefits be weighed against the possible risk.
The safety of Betahistine Hydrochloride in pregnancy has not been established. Therefore, its use in pregnancy or lactation, or in women of childbearing age requires that its potential benefits be weighed against the possible risks. This drug should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Betahistine is excreted in human milk; hence, its use in pregnancy or lactation, or in women with childbearing potential requires that the potential benefits be weighed against the possible risk.
Adverse Reactions
The most common adverse reactions reported in association with the use of Betahistine tablets are skin rashes of various types, urticaria, and itching.
Patients have experienced gastric upset, nausea, and headache.
Patients have experienced gastric upset, nausea, and headache.
Drug Interactions
There have been no reports of potentially hazardous interactions with other drugs.
No in vivo studies have been performed. In vitro data revealed no inhibition of cytochrome P450 enzymes.
In vitro data showed an inhibition of Betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) including MAO subtype B (e.g., Selegiline).
Caution is recommended when using Betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
Although antagonism between Betahistine and antihistamines may be expected theoretically, no such interactions have been reported.
The effects of Beta-2 agonists may be decreased by Betahistine.
There is a case report of potentiation of Betahistine with salbutamol and a case report of interaction with ethanol and maloprim.
No in vivo studies have been performed. In vitro data revealed no inhibition of cytochrome P450 enzymes.
In vitro data showed an inhibition of Betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) including MAO subtype B (e.g., Selegiline).
Caution is recommended when using Betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
Although antagonism between Betahistine and antihistamines may be expected theoretically, no such interactions have been reported.
The effects of Beta-2 agonists may be decreased by Betahistine.
There is a case report of potentiation of Betahistine with salbutamol and a case report of interaction with ethanol and maloprim.
Storage
Store at temperatures not exceeding 30°C .
Action
Pharmacology: Mode of Action: The mode of action of Betahistine was believed to be a direct stimulating (agonistic) effect on H1 receptors located on blood vessels in the inner ear. This would give rise to local vasodilation and increased permeability, which would help reverse the underlying problem of endolymphatic hydrops.
In addition, Betahistine has a powerful antagonistic effect at H3 receptors, and increases the levels of neurotransmitters released from the nerve endings.
Pharmacodynamics: The exact mechanism of action of Betahistine is unclear. However, animal studies have shown that Betahistine improves blood flow in the striae vascularis of the inner ear, resulting in reduced endolymphatic pressure.
Pharmacologic evaluation showed that Betahistine may exert weak H1 receptor agonistic activity and H3 antagonistic properties in the central and autonomic nervous systems. Betahistine also appears to inhibit spike generation of neurons in the lateral and medial vestibular nuclei in a dose-dependent manner.
Pharmacokinetics: Betahistine is rapidly and completely absorbed after oral administration. It is rapidly and almost completely metabolized into 2-pyridylacetic acid (2-PAA), its main metabolite which has no pharmacological activity. Since plasma Betahistine levels are very low, pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine. Peak plasma concentrations of 2-PAA achieved one hour after oral administration in fasting subjects and declines with a half-life of about 3.5 hours. Tissue distribution of Betahistine in humans is unknown. The drug has little or no binding to either serum albumin, or other plasma proteins.
It is not known to what extent the drug crosses the placenta. The effects of hepatic and renal disease on the kinetics of Betahistine are unknown.
Betahistine is eliminated in the kidney with 85 to 90% of the radioactivity of an 8 mg dose appearing in the urine over 56 hours. The maximum rates of excretion are reached within 2 hours of administration. The drug is excreted in the urine as 2-PAA with no unchanged Betahistine being detected.
In addition, Betahistine has a powerful antagonistic effect at H3 receptors, and increases the levels of neurotransmitters released from the nerve endings.
Pharmacodynamics: The exact mechanism of action of Betahistine is unclear. However, animal studies have shown that Betahistine improves blood flow in the striae vascularis of the inner ear, resulting in reduced endolymphatic pressure.
Pharmacologic evaluation showed that Betahistine may exert weak H1 receptor agonistic activity and H3 antagonistic properties in the central and autonomic nervous systems. Betahistine also appears to inhibit spike generation of neurons in the lateral and medial vestibular nuclei in a dose-dependent manner.
Pharmacokinetics: Betahistine is rapidly and completely absorbed after oral administration. It is rapidly and almost completely metabolized into 2-pyridylacetic acid (2-PAA), its main metabolite which has no pharmacological activity. Since plasma Betahistine levels are very low, pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine. Peak plasma concentrations of 2-PAA achieved one hour after oral administration in fasting subjects and declines with a half-life of about 3.5 hours. Tissue distribution of Betahistine in humans is unknown. The drug has little or no binding to either serum albumin, or other plasma proteins.
It is not known to what extent the drug crosses the placenta. The effects of hepatic and renal disease on the kinetics of Betahistine are unknown.
Betahistine is eliminated in the kidney with 85 to 90% of the radioactivity of an 8 mg dose appearing in the urine over 56 hours. The maximum rates of excretion are reached within 2 hours of administration. The drug is excreted in the urine as 2-PAA with no unchanged Betahistine being detected.
MedsGo Class
Antivertigo Drugs
Features
Brand
Verbeta 24
Full Details
Dosage Strength
24 mg
Drug Ingredients
- Betahistine
Drug Packaging
Dispersible Tablet 1's
Generic Name
Betahistine Hydrochloride
Dosage Form
Dispersible Tablet
Registration Number
DRP-5644-03
Drug Classification
Prescription Drug (RX)