Betahistine Schedule (India)

Schedule H

Betahistine Routes

Oral

Betahistine Formulations

Tablets: 8 mg

Tablets: 16 mg

Tablets: 24 mg

Betahistine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Ménière's Disease — Adults

Parameter Recommendation

Starting dose 8 mg orally three times daily OR 16 mg twice daily

Titration Adjust after 2–4 weeks based on symptom response and tolerability

Usual maintenance dose 24–48 mg/day in 2–3 divided doses

Maximum dose 48 mg/day

Clinical Notes:

Therapeutic effect may be delayed by 2–4 weeks; counsel patients regarding adherence

Reduces frequency and severity of vertigo attacks; may also improve tinnitus and hearing

Not effective for acute vertigo attack — use vestibular suppressants (promethazine, meclizine) for acute episodes

Continue treatment for at least 2–3 months before assessing efficacy

Vestibular Vertigo (Peripheral Vestibular Disorders) — Adults

Parameter Recommendation

Starting dose 8 mg orally three times daily

Titration Increase to 16 mg three times daily if tolerated and response inadequate

Usual maintenance dose 24–48 mg/day in divided doses

Maximum dose 48 mg/day

Duration: Typically 1–3 months; reassess need for continued therapy

Clinical Notes:

Used for chronic/recurrent vestibular symptoms, not acute vertigo

Efficacy in non-Ménière's vestibular disorders is less well established

Consider vestibular rehabilitation therapy as adjunct

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Vestibular Migraine 16 mg twice daily 2–3 months trial OFF-LABEL • Specialist only • Indian ENT/neurology practice • Limited RCT evidence

Recurrent BPPV (Prophylaxis) 8–16 mg twice daily Up to 3 months; reassess OFF-LABEL • Specialist only • Observational studies; Indian ENT practice

Tinnitus (without Ménière's) 16–24 mg twice daily 3 months trial OFF-LABEL • Specialist only • Variable response; limited evidence

Betahistine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not routinely recommended in children and adolescents under 18 years — insufficient safety and efficacy data.

Secondary Indications — Paediatric (Off-label)

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

12–17 years Chronic vestibular dysfunction Starting: 8 mg twice daily; may increase to 16 mg twice daily OFF-LABEL • Specialist only • ENT/neurology supervision mandatory

Safety Monitoring:

Monitor for headache, GI disturbances

Assess symptom response after 4 weeks

No routine laboratory monitoring required

Age Restrictions:

Not recommended in children below 12 years due to lack of safety data

Use in adolescents 12–17 years only under specialist ENT or neurology supervision

Betahistine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
≥60	No adjustment required
30–59	No adjustment required; use with caution
<30	Limited data; use with caution; consider reduced starting dose (8 mg twice daily)
Haemodialysis	: No formal data; use with caution under specialist supervision.

Betahistine Hepatic adjustment

Severity	Recommendation
Mild impairment	No dose adjustment required
Moderate impairment Use with caution; consider reduced starting dose (8 mg twice daily)	; slower titration
Severe impairment	Avoid if possible; if essential, use lowest effective dose under specialist supervision — no formal safety data

Betahistine Contraindications

Known hypersensitivity to betahistine dihydrochloride or any excipient

Phaeochromocytoma (risk of catecholamine release and hypertensive crisis)

Active peptic ulcer disease (histamine agonist effect may stimulate gastric acid secretion)

Betahistine Cautions

History of peptic ulcer disease — may exacerbate; consider PPI cover

Bronchial asthma — histamine agonism may theoretically worsen bronchoconstriction; use with monitoring

Hypotension — rare vasodilatory effect; monitor especially in elderly

Urticaria or allergic conditions — histamine agonism may theoretically worsen symptoms

Concurrent use of H1 antihistamines — may reduce therapeutic effect of betahistine

Pregnancy and lactation — use only if clearly indicated

Betahistine Pregnancy

Parameter Information

Risk Category Limited human data; animal studies inconclusive

Overall Safety Use with caution; only if benefit clearly outweighs risk

Preferred Alternatives Vestibular suppressants (promethazine, meclizine) for acute vertigo episodes

When May Be Used Chronic Ménière's disease significantly affecting quality of life — ENT and obstetric joint decision

Monitoring Maternal blood pressure; fetal growth if prolonged use

Betahistine Lactation

Parameter Information

Compatibility Unknown — limited data; likely compatible based on pharmacokinetics

Expected Milk Levels Expected to be low (small molecule, short half-life)

Preferred Alternatives Short-term antihistamines (promethazine) for acute vertigo

Decision May use if clearly indicated; observe infant

Infant Monitoring Sedation, feeding difficulties, irritability (unlikely)

Betahistine Elderly

Parameter Recommendation

Starting dose 8 mg twice daily

Titration Slow upward titration; increase after 2 weeks if tolerated

Special considerations Increased sensitivity to vasodilatory effects; higher fall risk from underlying vestibular disorder

Extra monitoring Blood pressure; balance and fall risk assessment; cognitive effects

Risk factors Polypharmacy; concurrent use of antihypertensives; impaired renal function

Betahistine Major drug interactions

Interacting Drug Effect & Mechanism Management

MAO Inhibitors (non-selective) May increase betahistine levels through inhibition of metabolism by MAO-B Avoid concurrent use or use with extreme caution; monitor for adverse effects

H1 Antihistamines (chlorpheniramine, diphenhydramine, promethazine) Pharmacological antagonism — may reduce therapeutic effect of betahistine on vestibular system Avoid long-term concurrent use; short-term use for acute attacks acceptable

Betahistine Moderate drug interactions

Interacting Drug Effect Management

Beta-blockers Theoretical additive hypotensive effect Monitor blood pressure

Antihypertensives Potential additive hypotension (rare) Monitor blood pressure especially in elderly

PPIs / H2 blockers No significant interaction; often co-prescribed to manage GI adverse effects Safe combination

Levocetirizine, cetirizine, fexofenadine May partially antagonise betahistine effect (though less than sedating antihistamines) Consider if betahistine efficacy seems reduced

Betahistine Common Adverse effects

Headache

Nausea

Dyspepsia / Gastric discomfort

Abdominal bloating

Fatigue

Drowsiness (uncommon)

Betahistine Serious Adverse effects

Adverse Effect Clinical Action

Hypersensitivity reaction (rash, urticaria, angioedema) Immediate discontinuation; supportive management

Severe hypotension Discontinue; supportive care; more likely in elderly or with concurrent antihypertensives

Bronchospasm (in asthmatics) Discontinue; bronchodilator therapy

GI bleeding (reactivation of peptic ulcer) Discontinue; GI evaluation; PPI therapy

Betahistine Monitoring requirements

Timing	Parameters
Baseline	Blood pressure; GI history (peptic ulcer); respiratory history (asthma)

After initiation (2–4 weeks) Symptom assessment (vertigo frequency/severity); GI tolerance; blood pressure

Long-term Periodic efficacy assessment (every 3–6 months); reassess need for continued therapy; GI symptoms

Betahistine Brands in India

Vertin (Abbott)

Betavert (Sun Pharma)

Bestone (Macleods)

Meniace (Intas)

Betahist (Cipla)

Betaserc (Abbott — limited availability)

Vestibo (Torrent)

Betaday (Alkem)

Multiple generic formulations

Note: Monotherapy preferred; some FDCs with cinnarizine available but not recommended for optimal dose titration.

Betahistine Price range (INR)

Formulation	Approximate Price (per tablet)
Tablet 8 mg ₹2–₹4 per tablet
Tablet 16 mg ₹3–₹6 per tablet
Tablet 24 mg ₹5–₹10 per tablet

Note: Not included in NLEM 2022; not under NPPA price control. Prices vary between brands.

Betahistine Clinical pearls

Delayed onset of action — counsel patients that meaningful improvement in vertigo frequency may take 2–4 weeks; premature discontinuation is a common cause of treatment failure

Not for acute vertigo — betahistine is prophylactic/maintenance therapy; use vestibular suppressants (promethazine, meclizine, dimenhydrinate) for acute vertigo episodes

Avoid long-term antihistamines concurrently — H1 antihistamines (especially sedating ones) can antagonise betahistine's therapeutic effect; limit to short-term use for acute attacks

GI protection in at-risk patients — consider PPI cover in patients with history of peptic ulcer disease or concurrent NSAID use

Adequate dosing is essential — underdosing is common; most patients require 24–48 mg/day for optimal effect

Reassess periodically — if no improvement after 3 months at adequate dose, reconsider diagnosis and alternative therapies

Betahistine Tags

Betahistine; antivertigo; Ménière's disease; vestibular vertigo; H3 antagonist; histamine analogue; ENT; tinnitus; elderly-caution; asthma-caution; peptic ulcer-caution

Betahistine Version

RxIndia v1.0 — 05 Jan 2025

Betahistine Reference

CDSCO Approved Drug Formulations Database

Indian Pharmacopoeia 2022

National Formulary of India 2021

API Textbook of Medicine, 11th Edition

AIIMS ENT Department Clinical Protocols

Harrison's Principles of Internal Medicine, 21st Edition (Vestibular disorders)

Goodman & Gilman's The Pharmacological Basis of Therapeutics

Indian ENT and neurology specialist practice patterns

Manufacturer Product Inserts (Abbott, Sun Pharma)

RxIndia

The Drug Registry

Betahistine