BETAGEN 24/MG TAB 50/TAB

Indications

Approved Uses

Ménière’s disease/syndrome (symptomatic treatment of vertigo, tinnitus and hearing loss associated with Ménière’s).

Off-Label Uses

Off-label: other vestibular disorders/vertigo syndromes (e.g., vestibular migraine/other peripheral vertigo) where used by specialists; not established for motion-sickness prophylaxis.

Dosage & Administration

Dosing by Condition

Ménière’s disease/syndrome: total 24-48 mg/day in divided doses; with 24 mg tablets, 24 mg twice daily is a common regimen; usual maximum 48 mg/day.

Initial Dose

24mg to 48mg per day, divided into two or three doses.

Maintenance Dose

24mg to 48mg daily in divided doses, adjusted according to patient response.

Maximum Dose

48 mg per day

Children's Dosage

Not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.

Safety & Warnings

Age Restriction

Not approved under 18 years.

Drug Interactions

Food Interaction

Take with food

Special Populations

Children

Not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.

Storage & Patient Advice

Overdose

Symptoms: nausea, vomiting, dyspepsia/abdominal pain, somnolence/drowsiness; at very high doses (especially with co-ingestants) seizures/convulsions and cardiopulmonary complications have been reported. Management: no specific antidote-supportive/symptomatic care; consider activated charcoal if early after ingestion and clinically appropriate; urgent medical evaluation is recommended.

Pharmacology

Mechanism of Action

Weak H1 agonist and strong H3 antagonist: increases histaminergic activity and improves inner-ear microcirculation, reducing endolymphatic pressure and vestibular symptoms.

Onset of Action

Clinical improvement often begins after ~2 weeks; maximal benefit may require several weeks to a few months of continuous therapy.

Duration of Effect

Effect is maintained only with continued regular dosing; symptoms may recur after discontinuation (no defined single-dose duration).

Bioavailability

Oral absorption is rapid and essentially complete; absolute bioavailability is not well established/commonly not stated as a precise percentage.

Excretion

Excreted mainly in urine, predominantly as the inactive metabolite 2‑pyridylacetic acid (2‑PAA).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 24 mg betahistine dihydrochloride

Generic Availability

Yes

Primary Use

Used to reduce episodes of vertigo (dizziness), tinnitus (ringing in the ears), and hearing loss associated with Ménière's disease.

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