LAVISTINA 8/MG TAB 100/TAB

Indications

Approved Uses

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

Dosage & Administration

Initial Dose

8-16 mg 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 age 18 due to lack of data on safety and efficacy.

Side Effects

Common Side Effects

Headache, nausea, dyspepsia/indigestion; may also cause abdominal pain and bloating.

Side Effect Frequency

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

Safety & Warnings

Contraindications

Hypersensitivity to betahistine (betahistine dihydrochloride) or any excipients; pheochromocytoma.

Warnings & Precautions

Use with caution in patients with bronchial asthma and in those with active or history of peptic ulcer disease/dyspepsia; contraindicated in pheochromocytoma.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

MAO inhibitors (including MAO-B inhibitors) may increase betahistine exposure; antihistamines may reduce betahistine’s effect (pharmacodynamic antagonism).

Interaction Severity

MAO inhibitors: moderate (may increase betahistine exposure); antihistamines: moderate (may reduce betahistine effect via pharmacodynamic antagonism).

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 may include nausea, vomiting, dyspepsia/abdominal pain, somnolence/drowsiness, and ataxia; seizures/convulsions and cardio‑pulmonary complications have been reported with very high doses. Management: no specific antidote-provide supportive/symptomatic care; consider activated charcoal if recent ingestion and seek urgent medical attention.

Pharmacology

Mechanism of Action

Partial agonist at histamine H1 receptors and antagonist at presynaptic H3 receptors, increasing histamine turnover/release and improving inner-ear microcirculation to facilitate vestibular compensation.

Half-Life

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

Bioavailability

Orally absorbed and rapidly converted to the main metabolite (2-pyridylacetic acid); absolute bioavailability of unchanged betahistine is not well characterized, but absorption is rapid with peak metabolite levels typically within ~1 hour.

Metabolism

Rapid and almost complete metabolism to inactive 2‑pyridylacetic acid (2‑PAA), mainly via oxidative deamination (MAO pathways); not a clinically significant CYP450 substrate.

Excretion

Primarily renal; ~85-90% of the dose is recovered in urine within 24 hours mainly as the inactive metabolite 2‑pyridylacetic acid (2‑PAA).

Protein Binding

Negligible/low protein binding (<5%).

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: 8 mg betahistine as dihydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Primary Use

Used to treat symptoms of Ménière's disease, which include dizziness (vertigo), ringing in the ears (tinnitus), and hearing loss.

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