BETASERC 8/MG TAB 100/TAB

Indications

Approved Uses

Symptomatic treatment of Ménière’s syndrome/disease (episodes of vertigo, tinnitus and fluctuating hearing loss).

Dosage & Administration

Dosing by Condition

Ménière’s syndrome/disease: 24-48 mg/day orally in divided doses (e.g., 8-16 mg three times daily); maximum commonly 48 mg/day.

Initial Dose

8mg to 16mg three times daily.

Maintenance Dose

24-48 mg per day in 2-3 divided doses

Maximum Dose

48 mg per day

Children's Dosage

Not recommended for use in children and adolescents below 18 years of age.

How to Take

Take orally with water; preferably with or after food to reduce gastrointestinal upset; take in divided doses evenly spaced through the day.

Side Effects

Common Side Effects

Nausea, dyspepsia/indigestion, headache (sometimes abdominal pain/bloating).

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 18 years of age.

Storage & Patient Advice

Overdose

Symptoms: nausea, somnolence/drowsiness, abdominal pain; at higher doses convulsions and cardio‑pulmonary complications have been reported. Management: no specific antidote-provide symptomatic and supportive care; consider GI decontamination (e.g., activated charcoal) if recent ingestion per standard toxicology practice.

Pharmacology

Mechanism of Action

Partial/weak H1 agonist and H3 antagonist that increases histaminergic activity and may improve inner-ear microcirculation, reducing endolymphatic pressure and vestibular symptoms.

Onset of Action

Improvement may begin after 2-4 weeks; maximal benefit may require several months of continuous therapy.

Duration of Effect

Not an immediate per-dose effect; benefit is maintained with continuous daily dosing and typically builds over weeks.

Bioavailability

Orally absorbed; absolute bioavailability is not well established/commonly reported (often described as well absorbed but rapidly metabolized).

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: 8 mg betahistine as dihydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

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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