Schedule H

Oral, Intramuscular, Intravenous, Rectal

Formulation Type Available Strengths

Tablets 5 mg, 10 mg

Injection (IM/IV) 12.5 mg/mL (2 mL ampoule)

Rectal suppository 25 mg (limited availability)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Nausea and Vomiting (Adults)

Post-operative, drug-induced, migraine-associated, gastroenteritis-related

Oral Route:

Parameter Recommendation

Starting dose 5–10 mg every 6–8 hours

Titration Increase frequency to every 6 hours based on symptom control

Usual maintenance dose 15–30 mg/day in 3 divided doses

Maximum dose 40 mg/day

Intramuscular/Intravenous Route:

Parameter Recommendation

Starting dose 12.5 mg IM or slow IV

Titration May repeat after 6 hours if needed

Usual maintenance dose 12.5–25 mg/day

Maximum dose 40 mg/day

Clinical notes:

• IM/IV route preferred for acute severe vomiting; transition to oral once tolerated

• IV administration: dilute in 10–20 mL NS and give slowly over 5–10 minutes to avoid hypotension

• Short-term use recommended; avoid prolonged therapy

1. Vertigo (Adults)

Including Ménière's disease, labyrinthitis, vestibular neuritis

Parameter Recommendation

Starting dose 5 mg three times daily orally

Titration Adjust based on symptom control; may increase to four times daily

Usual maintenance dose 15–20 mg/day in divided doses

Maximum dose 30 mg/day

Clinical notes:

• Use for shortest effective duration

• Particularly effective for vestibular causes of vertigo

• May combine with vestibular rehabilitation exercises

1. Acute Migraine Attack — Adjunctive Therapy (Adults)

Parameter Recommendation

Starting dose 12.5 mg IM as single dose early in migraine attack

Titration Not applicable for single-dose use

Usual maintenance dose Single dose; may repeat once after 6–8 hours if necessary

Maximum dose 25 mg per migraine episode

Clinical notes:

• Administer early in migraine episode for best efficacy

• Often combined with NSAID or triptan for synergistic effect

• Addresses both nausea and gastric stasis associated with migraine

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence

Schizophrenia / Acute psychosis Starting: 12.5 mg twice daily orally; Target: 25–75 mg/day in divided doses; Maximum: 100 mg/day Variable OFF-LABEL; Specialist only; largely replaced by atypical antipsychotics Historical use; Indian psychiatric practice

Intractable hiccups 5–10 mg orally three times daily Short-term OFF-LABEL; Specialist only Case series; Indian hospital practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Nausea and Vomiting (Children ≥2 years)

Post-operative, chemotherapy-induced, gastroenteritis-related

2–5 years >10 kg Oral/IM 0.25 mg/kg/dose OR 2.5 mg fixed Every 8–12 hours 7.5 mg

6–12 years — Oral/IM 2.5–5 mg 2–3 times daily 15 mg

12 years — Oral/IM Adult dosing applies — 40 mg

Safety Monitoring in Paediatrics:

• Monitor closely for extrapyramidal symptoms — particularly acute dystonia (more common in children)

• Have IV diphenhydramine or benztropine available for dystonic reactions

• Avoid dehydration — increases EPS risk

• Use for shortest possible duration

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Notes Evidence

Vertigo / Motion sickness ≥6 years 2.5–5 mg 2–3 times daily OFF-LABEL; Specialist only; short-term use Limited data; alternative agents (promethazine, ondansetron) often preferred

Important statements:

• Contraindicated in children below 2 years of age or weighing less than 10 kg due to high risk of dystonic reactions

• Use lowest effective dose for shortest duration

• Paediatrician supervision recommended for all uses

Mild to moderate impairment No dose adjustment required

• Known hypersensitivity to prochlorperazine or other phenothiazines

• Comatose states or severe CNS depression

• Children below 2 years of age or weighing less than 10 kg

• Phaeochromocytoma (risk of hypertensive crisis)

• Bone marrow depression or blood dyscrasias

• Concurrent high-dose CNS depressants (opioids, barbiturates)

• Parkinson's disease or dementia with Lewy bodies

• Elderly patients — significantly increased risk of extrapyramidal symptoms and sedation

• History of seizures or epilepsy — may lower seizure threshold

• Cardiovascular disease — risk of QT prolongation and hypotension

• Narrow-angle glaucoma — anticholinergic effects may precipitate attack

• Prostatic hypertrophy or urinary retention

• History of neuroleptic malignant syndrome

• Dehydration or electrolyte imbalance — increases EPS risk

• Hepatic impairment

• Prolonged use — risk of tardive dyskinesia

• Hot weather or fever — impaired thermoregulation

Parameter Recommendation

Overall safety Limited data; generally considered safer in 2nd and 3rd trimesters for short-term use

Preferred alternative Ondansetron (after first trimester), doxylamine + pyridoxine (for NVP), metoclopramide

When may be used Hyperemesis gravidarum not responding to first-line agents; benefit must outweigh risk

What to monitor Maternal sedation, EPS; fetal activity if prolonged use; neonatal EPS if used near delivery

Parameter Recommendation

Compatibility Compatible with breastfeeding for short-term use with monitoring

Preferred alternative Ondansetron, domperidone (for nausea with galactagogue effect)

Drug levels in milk Low to moderate

Infant monitoring Sedation, feeding difficulties, irritability, extrapyramidal signs

Parameter Recommendation

Starting dose 2.5–5 mg orally (50% of adult dose)

Titration Slow; increase only if essential after 2–3 days

Special risks Extrapyramidal reactions (acute dystonia, parkinsonism); orthostatic hypotension leading to falls; sedation; confusion; anticholinergic effects; tardive dyskinesia with prolonged use

Additional considerations Use shortest effective duration; avoid chronic use; consider alternatives (ondansetron) if EPS risk is high

Interacting Drug Effect / Risk Recommendation

Levodopa / Dopamine agonists Antagonism of dopamine receptors — reduces antiparkinsonian effect Avoid combination; contraindicated in Parkinson's disease

CNS depressants (benzodiazepines, opioids, barbiturates) Additive CNS and respiratory depression Avoid or reduce doses significantly

QT-prolonging drugs (haloperidol, amiodarone, methadone, fluoroquinolones, macrolides) Additive QT prolongation — risk of torsades de pointes Avoid combination; if essential, monitor ECG

Alcohol Potentiates sedation and hypotension Contraindicated

Metoclopramide Additive dopamine blockade — markedly increased EPS risk Avoid concurrent use

Interacting Drug Effect / Risk Recommendation

Anticholinergics (tricyclics, antihistamines) Additive anticholinergic effects — urinary retention, constipation, confusion Monitor closely; avoid in elderly

Antihypertensives Additive hypotensive effect Monitor BP; may need dose adjustment of antihypertensive

Lithium Risk of neurotoxicity; may mask lithium toxicity symptoms (nausea) Monitor lithium levels and neurological status

Antiepileptics May lower seizure threshold Monitor seizure control

Tramadol Increased seizure risk Use with caution

• Drowsiness and sedation

• Dizziness

• Dry mouth

• Blurred vision

• Constipation

• Urinary hesitancy

• Orthostatic hypotension

• Nasal congestion

Adverse Effect Notes

Extrapyramidal symptoms (acute dystonia, akathisia, parkinsonism) May require anticholinergic treatment; consider discontinuation

Tardive dyskinesia Risk with prolonged use; may be irreversible

Neuroleptic malignant syndrome Medical emergency — discontinue immediately, supportive care

QT prolongation / Torsades de pointes Baseline and periodic ECG if risk factors present

Agranulocytosis Rare; monitor CBC if use exceeds 3 weeks

Cholestatic jaundice Discontinue if liver function deteriorates

Photosensitivity / Skin pigmentation Rare; advise sun protection

Long-term (>3 weeks) CBC (for agranulocytosis); monitor for tardive dyskinesia

All patients Symptom response; tolerability assessment

• Stemetil® (Abbott)

• Vomitil®

• Proclor®

• Emetil®

• Multiple generic formulations available

Notes:

• Prices vary by brand and procurement setting (private vs. government)

• Not included under NLEM price control

1. Vestibular nausea: More effective than ondansetron for vertigo-associated nausea and migraine-related vomiting.

1. Emergency department use: Single IM dose of 12.5 mg is effective for acute migraine or intractable vomiting when oral route fails.

1. EPS risk: Higher extrapyramidal risk compared to newer antiemetics (ondansetron, granisetron) — keep anticholinergic available for acute dystonia.

1. Avoid combination: Do not co-administer with metoclopramide — significant additive EPS risk.

1. Age restrictions: Strictly avoid in children under 2 years; extreme caution in elderly (start at half dose).

1. Duration: Limit use to shortest effective period; chronic use increases tardive dyskinesia risk.

antiemetic; phenothiazine; dopamine-antagonist; vertigo; migraine; EPS-risk; elderly-caution; pregnancy-compatible-short-term; Schedule-H; Prochlorperazine

RxIndia v1.1 — 16 Mar 2025

• CDSCO approved product labelling

• Indian Pharmacopoeia / National Formulary of India 2021

• AIIMS Pocket Drug Formulary

• API Textbook of Medicine (11th edition)

• IAP Guidelines on Antiemetic Use in Children

• Indian specialist practice: Neurology (migraine), ENT (vertigo), Oncology (chemotherapy-induced emesis)