Schedule H

Oral

• Tablet 25 mg

• Tablet 12.5 mg (less commonly available)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Vertigo (Vestibular Origin — Labyrinthitis, Meniere's Disease, Vestibular Neuritis)

Parameter Recommendation

Starting dose 25 mg orally once daily

Titration May increase to 25 mg every 6–8 hours based on response

Usual maintenance dose 25–100 mg/day in 2–4 divided doses

Maximum dose 100 mg/day

Clinical Notes:

• Onset of action typically within 1–2 hours

• Use lowest effective dose for shortest duration

• Vertigo of central origin (e.g., stroke) usually unresponsive — confirm peripheral vestibular etiology

1. Motion Sickness (Prophylaxis and Treatment)

Parameter Recommendation

Starting dose 25–50 mg orally, 1 hour before travel

Titration Not applicable

Usual maintenance dose 25 mg every 24 hours during travel

Maximum dose 50 mg/24 hours

Clinical Notes:

• More effective as prophylaxis than for active nausea/vomiting

• Single pre-travel dose often sufficient for short journeys

• Longer duration of action compared to dimenhydrinate

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Nausea associated with vestibular migraine (OFF-LABEL) 25 mg orally once or twice daily Short-term only Specialist supervision recommended; evidence from small RCTs and Indian ENT specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Motion Sickness (Prophylaxis)

≥12 years 25–50 mg orally Once daily, 1 hour before travel 50 mg/day

6–11 years 12.5 mg orally Once or twice daily 25 mg/day

<6 years Not recommended — —

Clinical Notes:

• More effective when given before travel

• Monitor for excessive sedation and paradoxical excitation in younger children

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Duration Notes

Vertigo (vestibular cause) — OFF-LABEL ≥12 years 25 mg orally once or twice daily Short-term Specialist only; limited paediatric safety data

Vertigo (vestibular cause) — OFF-LABEL 6–11 years 12.5 mg orally once or twice daily Short-term Specialist only; avoid prolonged use

Safety Notes:

• Not recommended under age 6 years except under ENT/paediatric super-specialist guidance

• Monitor for CNS depression, particularly with concurrent sedative use

• Prolonged use safety not established in children

Mild–Moderate impairment No dose adjustment required

Severe impairment Use caution; initiate at lower dose (25 mg/day)

Dialysis Not significantly dialyzable; dose modification not required

• Hypersensitivity to meclizine or piperazine derivatives

• Acute angle-closure glaucoma

• Significant urinary retention due to prostatic hypertrophy

• Concurrent CNS depressant overdose/toxicity

• Elderly patients (heightened anticholinergic and sedative effects)

• Seizure disorders (may lower seizure threshold)

• Chronic hepatic impairment

• Narrow-angle glaucoma (monitor intraocular pressure)

• Bladder outflow obstruction

• Concurrent use with other anticholinergic agents

• Patients at risk of falls

Parameter Recommendation

Overall safety Generally considered compatible; used in pregnancy-related nausea

Trimester preference Preferably after first trimester; acceptable in 2nd/3rd trimester

When to use When benefit outweighs risk (e.g., hyperemesis gravidarum, severe motion sickness)

Preferred alternatives Doxylamine + pyridoxine (first-line for pregnancy nausea in India)

Monitoring Observe for excessive maternal sedation; no specific fetal monitoring required

Parameter Recommendation

Compatibility Compatible with breastfeeding

Milk levels Low (limited transfer expected)

Preferred alternatives Generally acceptable; promethazine less preferred due to higher sedation

Infant monitoring Observe for drowsiness, feeding difficulty, poor weight gain

Parameter Recommendation

Starting dose 25 mg once daily

Titration Slow; increase only if tolerated and needed

Key risks Sedation, confusion, urinary retention, constipation, blurred vision, falls

Clinical advice Consider non-sedating alternatives (e.g., betahistine) for chronic vestibular disorders

Interacting Drug Effect Management

Alcohol Additive CNS depression Avoid concurrent use

Benzodiazepines, opioids, sedative-hypnotics Enhanced sedation, respiratory depression risk Avoid or use with extreme caution

MAO inhibitors Potential enhanced anticholinergic toxicity Avoid combination

Strong anticholinergic agents (oxybutynin, tricyclic antidepressants) Additive anticholinergic burden Avoid in elderly and high-risk patients

Interacting Drug Effect Management

Antihypertensives Increased orthostatic hypotension Monitor blood pressure; advise slow postural changes

SSRIs/SNRIs Additive dizziness or sedation Monitor; dose adjustment rarely needed

Antiepileptics (phenytoin, carbamazepine) Additive CNS effects Monitor for excessive sedation

Antitubercular drugs (isoniazid) No direct interaction Use caution in hepatic impairment

• Drowsiness

• Dry mouth

• Dizziness

• Headache

• Blurred vision

• Fatigue

• Acute angle-closure glaucoma (in predisposed individuals)

• Urinary retention (especially elderly males with prostatic hypertrophy)

• Cognitive impairment/delirium (in elderly or dementia patients)

• Seizure exacerbation in epileptic patients

• Severe allergic reactions (rash, urticaria, angioedema — rare)

Phase Parameters

Baseline Assess fall risk, urinary symptoms, glaucoma history, cognitive status

After initiation Monitor sedation level, dizziness, urinary symptoms within first few days

Long-term Not recommended for chronic use; reassess indication periodically; check for anticholinergic burden in elderly

• Meclizest

• Vertigon-M

• Dizitab

• Meclon

(Note: Meclizine is often co-formulated with cinnarizine or nicotinic acid — verify single-ingredient vs combination product)

• Not under NLEM/NPPA price control

• Price varies by brand and region

• Superior as prophylaxis for motion sickness; less effective once symptoms begin

• Preferred over dimenhydrinate for longer action and relatively lower sedation

• Vertigo of central origin (brainstem stroke, posterior fossa lesion) does not respond — always confirm peripheral vestibular cause

• Avoid driving or operating machinery for at least 4–6 hours after dose

• Betahistine is preferred over meclizine for chronic vertigo management in elderly due to lower anticholinergic burden

• Reassess need if symptoms persist beyond 1–2 weeks — chronic vestibular suppression may delay compensation

Meclizine; antihistamine; vertigo; motion sickness; vestibular suppressant; H1-blocker; dizziness; anticholinergic; pregnancy-compatible; Schedule H

RxIndia v1.1 — 09 Jul 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia

• National Formulary of India (NFI) 2021

• AIIMS Medicine OPD Protocols

• API Textbook of Medicine

• ICMR Guidelines on Antiemetics in Pregnancy

• IAP Dosing Guidelines (Paediatric)

• Indian ENT specialist clinical practice