BETASERC 24/MG TAB 50/TAB

Indications

Approved Uses

Ménière’s syndrome/disease (symptoms such as vertigo, tinnitus and hearing loss) and symptomatic treatment of vestibular vertigo.

Off-Label Uses

Used for vertiginous syndromes such as positional paroxysmal vertigo and vertigo secondary to vertebrobasilar insufficiency

Dosage & Administration

Dosing by Condition

Ménière’s disease/vestibular vertigo: total 24-48 mg/day orally in divided doses (e.g., 24 mg twice daily); maximum typically 48 mg/day.

Initial Dose

24 mg twice daily (48 mg/day

Maintenance Dose

24-48 mg daily, adjusted according to patient response.

Maximum Dose

48 mg daily. Higher doses up to 480 mg/day have been used in refractory cases under specialist supervision.

Children's Dosage

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

How to Take

Oral: swallow the tablet with water; take with or after food to reduce gastrointestinal upset.

Side Effects

Common Side Effects

Headache; nausea; dyspepsia/indigestion; mild gastrointestinal complaints (e.g., abdominal pain, abdominal distension/bloating, vomiting).

Side Effect Frequency

Common (≥1/100 to <1/10): nausea, dyspepsia, headache; Not known: hypersensitivity reactions (including rash, pruritus, urticaria, angioedema) and other gastrointestinal complaints (e.g., vomiting, abdominal pain, bloating).

Safety & Warnings

Contraindications

Hypersensitivity to betahistine dihydrochloride or to any excipients; pheochromocytoma.

Warnings & Precautions

Use with caution in bronchial asthma and in patients with active or history of peptic ulcer disease; avoid use in pheochromocytoma; pregnancy/lactation: use only if clearly needed (limited data).

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Potential interaction with MAO inhibitors (including MAO-B inhibitors) which may increase betahistine exposure; antihistamines may antagonize betahistine’s effect (reduced efficacy).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

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

Storage & Patient Advice

Stopping the Medicine

May be stopped without tapering; discontinue on clinician advice, noting symptoms may recur if stopped.

Overdose

Symptoms: nausea, vomiting, dyspepsia/abdominal pain, somnolence/drowsiness, ataxia; at high doses (especially with co-ingestants) seizures/convulsions and cardiopulmonary complications have been reported. Management: supportive/symptomatic care; consider activated charcoal if recent ingestion and airway protected; urgent medical evaluation.

Patient Counseling

Take with or after food and swallow with water; take regularly at the same times daily. Expect gradual improvement (weeks; sometimes months). Dizziness may affect driving/operating machinery. Tell your clinician if you have asthma or a history of peptic ulcer. Seek urgent care for allergic reactions (rash, swelling, breathing difficulty) or severe/worsening GI symptoms.

Pharmacology

Mechanism of Action

Histamine analogue acting as a weak H1 receptor agonist and potent H3 receptor antagonist; thought to improve inner-ear microcirculation and vestibular neurotransmission, reducing endolymphatic pressure and vertigo symptoms.

Onset of Action

Improvement is often seen after 2-4 weeks; maximal benefit may take several months of continuous therapy.

Duration of Effect

Symptom control is maintained with continued regular dosing; benefits typically wane after discontinuation (no defined single-dose duration).

Half-Life

Approximately 3-4 hours (commonly reported as the elimination half-life of the main metabolite 2‑PAA).

Metabolism

Rapid and extensive metabolism to 2‑pyridylacetic acid (2‑PAA), largely via oxidative deamination (MAO-mediated); not considered a clinically relevant CYP450 substrate.

Excretion

Primarily renal excretion, mainly as the inactive metabolite 2‑pyridylacetic acid (2‑PAA), with the majority of the dose recovered in urine within ~24 hours.

Product Information

Available Dosage Forms

Tablet (24 mg) for oral use.

Composition per Dose

Each tablet: 24 mg betahistine as dihydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Primary Use

Treatment of Ménière's disease and vestibular vertigo, reducing episodes of dizziness, tinnitus, and hearing disturbance

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