Schedule H

Oral

• Tablets: 8 mg

• Tablets: 16 mg

• Tablets: 24 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. 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

1. 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

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)

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

• 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)

• 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

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

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)

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

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

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

• Headache

• Nausea

• Dyspepsia / Gastric discomfort

• Abdominal bloating

• Fatigue

• Drowsiness (uncommon)

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

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

• 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.

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

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

RxIndia v1.0 — 05 Jan 2025

• 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)