Schedule H

Intramuscular (IM), Intravenous (IV)

• Injection: Ergometrine maleate 0.5 mg/mL (1 mL ampoule)

Note: Oral tablets (0.2 mg) are rarely available in India; injectable form is standard

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prevention of Postpartum Haemorrhage (Active Management of Third Stage of Labour — AMTSL)

Intramuscular Route (Preferred for Prophylaxis)

Step Dose Clinical Notes

Starting dose 0.5 mg IM immediately after delivery of anterior shoulder or placenta Single injection; onset 2–5 minutes

Titration Not applicable Single-dose prophylaxis

Usual maintenance dose Not applicable Usually one dose sufficient

Maximum dose 0.5 mg (single prophylactic dose) Do not repeat routinely for prophylaxis

Key points:

• Administer only AFTER delivery of the baby — never before delivery

• Rule out twin pregnancy before administration

• Combined oxytocin-ergometrine (Syntometrine) provides rapid and sustained uterotonic effect

1. Treatment of Postpartum Haemorrhage (Uterine Atony)

Intramuscular or Intravenous Route

Route Dose Clinical Notes

IM (preferred) 0.5 mg IM; may repeat every 2–4 hours if needed Safer route; avoids acute hypertensive response

IV (emergency only) 0.25–0.5 mg IV slowly over ≥1 minute Reserve for severe PPH; monitor BP closely

Maximum dose 1 mg in 24 hours (total of 2 doses) Exceeding this increases vasospastic toxicity risk

Key points:

• Second-line agent after oxytocin fails or is unavailable

• Ensure IV access and BP monitoring before IV administration

• Combine with bimanual uterine compression and IV fluid resuscitation

1. Prevention of Haemorrhage Following Incomplete Abortion/Miscarriage (After Evacuation)

Route Dose Clinical Notes

IM 0.5 mg IM after surgical evacuation Promotes uterine contraction; reduces bleeding

Maximum dose Single dose usually sufficient Repeat only if continued atony

Secondary Indications — Adults (Off-label)

Not applicable. Ergometrine is not routinely used for other indications in Indian clinical practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable. Ergometrine is not indicated in paediatric patients. Use is restricted to postpartum/post-abortion women.

Secondary Indications — Paediatrics (Off-label)

Not applicable.

Mild-moderate impairment No specific adjustment; use with caution

Severe impairment (eGFR <30) Avoid use if possible; increased risk of accumulation and hypertensive crisis

Dialysis No data available; avoid unless essential

Note: Limited pharmacokinetic data in renal impairment; use oxytocin as preferred alternative in severe renal dysfunction

• Hypertension (including gestational hypertension, pre-eclampsia, eclampsia)

• Ischaemic heart disease or coronary artery disease

• Peripheral vascular disease (including Raynaud's phenomenon)

• Cerebrovascular disease or history of stroke

• Sepsis or septicaemia

• Severe hepatic impairment

• Severe renal impairment

• Known hypersensitivity to ergometrine or other ergot alkaloids

• Use BEFORE delivery of the infant (risk of uterine tetany, fetal hypoxia, uterine rupture)

• Undiagnosed multiple pregnancy (before delivery of last baby)

• Concurrent use with potent CYP3A4 inhibitors (see Major Drug Interactions)

• Mild hypertension (controlled) — monitor BP closely

• Cardiac disease (non-ischaemic) — increased afterload may worsen condition

• Multiple gestation — increased uterine sensitivity

• History of migraine — may precipitate ergot-related headache

• Retained placenta — ensure placental expulsion or exclude before administration

• Concurrent use with other vasoconstrictors

• Grand multiparity — increased uterine sensitivity

• Obesity — may require clinical assessment of response

• Rapid IV injection — risk of acute severe hypertension (always inject slowly over ≥1 minute)

Parameter Recommendation

Safety category Contraindicated before delivery of infant; causes tetanic uterine contraction → fetal hypoxia, uterine rupture

Preferred alternatives Not applicable — ergometrine is used postpartum only; oxytocin is first-line for AMTSL

When it may be used Third stage of labour (after delivery) and immediately postpartum for PPH prevention/treatment

Monitoring Blood pressure; uterine tone; watch for signs of vasospasm

Note: NEVER administer ergometrine before delivery of the baby under any circumstance

Parameter Recommendation

Compatibility Compatible with breastfeeding in short-term, single-dose use

Drug levels in milk Low (single postpartum dose results in minimal infant exposure)

Preferred alternatives Oxytocin (if repeated dosing needed — no effect on lactation)

Infant monitoring Observe for irritability, poor feeding (rare with single dose); ergot alkaloids may theoretically suppress prolactin with repeated use

Note: Avoid repeated or high-dose use postpartum — may interfere with lactation establishment

Not applicable. Ergometrine is used exclusively in postpartum women; not indicated in elderly population.

Drug Interaction Management

Potent CYP3A4 inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, HIV protease inhibitors) Markedly increased ergometrine levels → severe and prolonged vasospasm, gangrene, ischaemia CONTRAINDICATED — do not use together

Triptans (sumatriptan, rizatriptan, etc.) Additive vasospasm → coronary and peripheral ischaemia AVOID — do not use within 24 hours of each other

Other ergot alkaloids (methylergometrine, ergotamine) Cumulative ergot toxicity → severe vasospasm, gangrene AVOID concurrent use

Sympathomimetic agents (adrenaline, noradrenaline, phenylephrine) Additive vasoconstriction and severe hypertension AVOID concurrent use; if essential, use lowest doses with close BP monitoring

Vasopressin/Desmopressin Additive vasoconstriction Avoid combination

Drug Interaction Management

Beta-blockers May enhance peripheral vasoconstriction from ergometrine Monitor for cold extremities, peripheral ischaemia

Dopamine agonists (bromocriptine, cabergoline) Additive vasoconstrictive effects Use with caution; monitor for vasospasm

Antihypertensives Opposing pharmacological effects; may reduce efficacy of antihypertensive Monitor blood pressure

Moderate CYP3A4 inhibitors (fluconazole, diltiazem, verapamil) Possible increased ergometrine levels Use with caution; monitor for ergot toxicity

Nitrates (GTN, isosorbide) May partially antagonise ergot-induced vasoconstriction; theoretical benefit in ergot toxicity Note for treatment of inadvertent overdose

• Nausea and vomiting

• Elevated blood pressure

• Abdominal cramping/pain

• Headache

• Dizziness

• Flushing

• Sweating

• Palpitations

Reaction Action Required

Hypertensive crisis Stop administration; immediate BP management; IV labetalol or hydralazine; ICU care if severe

Myocardial infarction / Coronary vasospasm Discontinue immediately; standard MI management; cardiology consultation

Cerebrovascular accident (Stroke) Discontinue; emergency stroke management; neurology input

Peripheral vasospasm / Limb ischaemia Discontinue; warming; IV vasodilators (nitroprusside, GTN); surgical consultation if severe

Seizures Discontinue; supportive care; benzodiazepines

Pulmonary oedema Discontinue; diuretics; oxygen; ICU care

Uterine tetany / Rupture (if given before delivery) Emergency laparotomy if rupture occurs

During IV administration Continuous BP monitoring; inject slowly over ≥1 minute

First 2 hours post-administration Blood pressure every 15–30 minutes; uterine tone assessment; vaginal bleeding

With repeated doses Watch for signs of ergot toxicity (cold extremities, numbness, chest pain, severe headache)

Single-ingredient products:

• Ergomar (Sun Pharma)

• Ergometrine IP (government supply — various PSU manufacturers)

• Ergomet (Samarth Pharma)

Fixed-dose combinations:

Note: Methylergometrine (Methergin) is a DIFFERENT drug — longer-acting ergot derivative; not interchangeable

NLEM status: Ergometrine injection (0.5 mg/mL) is included in NLEM 2022 — ceiling price applicable under NPPA

Government supply: Available through JSY and maternal health programmes at public facilities

• Hypertension is absolute contraindication: NEVER use ergometrine in pre-eclampsia/eclampsia or any hypertensive disorder — use oxytocin instead

• Slow IV injection is critical: Rapid IV push causes acute severe hypertension — always inject over at least 1 minute; IM route is safer for routine use

• Not first-line for AMTSL: WHO and Indian guidelines recommend oxytocin as first-line; ergometrine (or Syntometrine) is alternative when oxytocin unavailable or as second-line

• Maximum 1 mg in 24 hours: Exceeding this dose significantly increases risk of vasospastic complications including gangrene

• Different from methylergometrine: Ergometrine and methylergometrine are distinct drugs; methylergometrine is longer-acting — do not confuse or combine

• Cold chain less critical than oxytocin: Ergometrine is more heat-stable than oxytocin but still store appropriately

ergometrine; uterotonic; PPH prevention; PPH treatment; AMTSL; ergot alkaloid; hypertension contraindicated; vasospasm risk; postpartum; NLEM India

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• NLEM 2022 (National List of Essential Medicines)

• MoHFW Guidelines — Prevention and Management of Postpartum Haemorrhage

• FOGSI Good Clinical Practice Recommendations

• AIIMS Obstetrics Protocols

• WHO Recommendations on Uterotonics for Prevention of PPH (2018)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)