BETASERC 16/MG TAB 40/TAB

Indications

Approved Uses

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

Off-Label Uses

Off-label: vestibular vertigo/vestibular disorders outside Ménière’s (where not included in local labeling); other proposed uses (e.g., migraine) have limited/variable evidence and are not standard.

Dosage & Administration

Dosing by Condition

Ménière’s disease / vestibular vertigo: 24-48 mg/day orally in divided doses (e.g., 16 mg three times daily); maximum commonly 48 mg/day.

Initial Dose

16 mg three times daily (48 mg/day)

Maintenance Dose

24mg to 48mg daily in divided doses.

Maximum Dose

48 mg per day

Children's Dosage

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

How to Take

Swallow the tablet with water; take with or after food to reduce gastrointestinal upset.

Side Effects

Common Side Effects

Nausea, dyspepsia/indigestion, headache; may include abdominal pain/bloating.

Side Effect Frequency

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

Safety & Warnings

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

MAO inhibitors (including MAO-B inhibitors) may increase betahistine exposure/effects; antihistamines may theoretically reduce betahistine efficacy; no clinically established interaction with beta-2 agonists (theoretical only, not routinely listed).

Interaction Severity

MAO inhibitors: clinically relevant interaction (may increase betahistine exposure)-use caution; antihistamines: may reduce betahistine effect (pharmacodynamic antagonism)-avoid or monitor; other interactions are not well established.

Food Interaction

Food has little effect on absorption

Special Populations

Children

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

Storage & Patient Advice

Overdose

Overdose symptoms: nausea, somnolence/drowsiness, abdominal pain (± vomiting/ataxia); severe cases (often intentional) may include convulsions and cardiopulmonary complications; management is symptomatic/supportive (consider decontamination if early) and urgent medical evaluation.

Pharmacology

Mechanism of Action

Histamine analogue acting as an H1 agonist (weak/partial) and H3 antagonist, increasing histamine turnover/release and improving inner-ear microcirculation and vestibular compensation, reducing endolymphatic pressure.

Onset of Action

Clinical improvement may take 2-4 weeks; maximal benefit can require several weeks to months of regular dosing.

Duration of Effect

Requires regular continuous dosing; symptomatic benefit is maintained with ongoing use and typically diminishes after discontinuation.

Half-Life

Approximately 3-4 hours (reported for the main metabolite 2‑PAA).

Bioavailability

Orally absorbed and rapidly converted to the active metabolite (2-pyridylacetic acid); peak levels occur within a few hours; absolute bioavailability is not well characterized in many references.

Metabolism

Rapid and extensive metabolism to inactive 2‑pyridylacetic acid (2‑PAA); not reliably described as specifically hepatic/MAO-mediated in labeling.

Excretion

Renal; almost completely excreted in urine mainly as 2‑pyridylacetic acid (2‑PAA), with >90% recovered within 24 hours.

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 16 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 disturbances

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