LAVISTINA 16/MG TAB 40/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Ménière’s disease/vestibular vertigo: total 24-48 mg/day in 2-3 divided doses (e.g., 16 mg three times daily); maximum commonly 48 mg/day.

Maintenance Dose

24mg to 48mg daily in divided doses. [3, 6]

Maximum Dose

48mg per day. [3, 6]

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. [2, 6, 12]

Side Effects

Common Side Effects

Nausea, dyspepsia/indigestion, headache; may also cause abdominal pain and bloating.

Side Effect Frequency

Common: headache, nausea, dyspepsia/indigestion (may include mild GI upset such as abdominal pain, bloating). Frequency not known/rare: hypersensitivity reactions including rash, pruritus, urticaria, angioedema, and very rarely anaphylaxis/bronchospasm.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Use caution in bronchial asthma; peptic ulcer disease or history of ulcer (monitor for GI symptoms); patients with urticaria/rash/allergic rhinitis (may worsen); pregnancy and lactation: use only if clearly needed due to limited safety data; monitor for hypersensitivity.

Drug Interactions

Drug Interactions

MAO inhibitors (including MAO-B inhibitors) may increase betahistine exposure; antihistamines may antagonize/reduce betahistine effect (theoretical/clinical).

Special Populations

Pregnancy

Consult Doctor

Children

Not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy. [2, 6, 12]

Storage & Patient Advice

Overdose

Symptoms: nausea, vomiting, dyspepsia/abdominal pain, somnolence/drowsiness, headache, ataxia; seizures/convulsions and cardiopulmonary complications have been reported with very high doses or co-ingestants. Management: no specific antidote-supportive care; consider activated charcoal if recent ingestion and airway protected; urgent medical evaluation.

Pharmacology

Mechanism of Action

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

Duration of Effect

Requires regular continuous dosing; symptomatic benefit is maintained only with ongoing administration.

Product Information

Available Dosage Forms

Tablet (for this SFDA-registered product: LAVISTINA 16 mg tablet).

Composition per Dose

Each tablet: 16 mg betahistine dihydrochloride

Generic Availability

Yes

Primary Use

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

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