Product image of Mitrotan (Ergometrine Maleate) supplied by GNH India

Mitrotan

Active Ingredient:
Ergometrine Maleate
Origin:
EU

Mitrotan (Ergometrine Maleate)

Ergometrine maleate, the active ingredient in Mitrotan, is an ergot alkaloid presented as an injectable solution for intramuscular or intravenous use. It is employed to stimulate uterine contraction for the prevention and treatment of postpartum hemorrhage and uterine atony in postpartum women.

GNH India supplies Mitrotan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. Our distribution network ensures reliable access to quality‑assured products for obstetric care providers across global markets. We adhere to stringent regulatory standards to maintain product integrity from manufacture to delivery.

Manufacturer / TM Owner

Gap S.A.

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Indications & Clinical Uses

Ergometrine maleate is an ergot alkaloid uterotonic used in obstetric practice to promote uterine contraction.

  • Postpartum hemorrhage: controls severe bleeding by inducing rapid uterine contraction after delivery.
  • Uterine atony: restores tone in a relaxed uterus to prevent ongoing blood loss.
  • Prophylactic third‑stage management: administered prophylactically during the third stage of labor to reduce the incidence of postpartum hemorrhage.

How It Works

  • Ergometrine maleate acts as a partial agonist at serotonin 5‑HT2 receptors and alpha‑adrenergic receptors on uterine smooth‑muscle cells. Stimulation of these receptors increases intracellular calcium and activates phosphoinositide pathways, leading to sustained contraction of the myometrium. These effects are rapid, occurring within minutes of intravenous or intramuscular administration, and are dose‑dependent, providing clinicians with a controllable means to manage obstetric bleeding.

Side Effects

Ergometrine maleate may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild to moderate nausea occurring shortly after injection.
  • Vomiting: occasional emesis related to gastrointestinal irritation.
  • Hypertension: transient elevation of blood pressure.
  • Headache: mild headache reported by some patients.

Serious or Rare Side Effects

  • Coronary artery spasm: severe chest pain due to vasospasm.
  • Myocardial ischemia: reduced cardiac blood flow leading to angina or infarction.
  • Anaphylactic reaction: severe allergic response requiring immediate treatment.

Precautions & Warnings

When using ergometrine maleate, careful assessment and monitoring are essential to minimize risks.

  • Cardiovascular assessment: evaluate blood pressure and cardiac history before administration.
  • Hypertension monitoring: observe for sudden increases in blood pressure during and after dosing.
  • Caution in vascular disease: avoid use in patients with known coronary artery disease or peripheral vascular disorders.
  • Hypersensitivity screening: discontinue if signs of allergic reaction appear.
  • Use under obstetric supervision: ensure administration by qualified healthcare professionals in a setting equipped for emergency management.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Ergometrine maleate can interact with several medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • MAO inhibitors: concurrent use may cause severe hypertension or vasospasm.
  • Other ergot derivatives (e.g., bromocriptine): additive vasoconstrictive effects increase risk of ischemia.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise plasma concentrations, heightening adverse events.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: ergometrine may counteract blood‑pressure‑lowering effects.
  • SSRIs or other serotonergic drugs: potential for enhanced serotonergic activity and vascular effects.

Frequently Asked Questions

Mitrotan contains ergometrine maleate, a uterotonic agent used primarily to prevent and treat postpartum hemorrhage and to manage uterine atony after delivery. It helps achieve rapid uterine contraction, reducing blood loss during the third stage of labor.

Ergometrine maleate acts as a partial agonist at serotonin 5‑HT2 and alpha‑adrenergic receptors on uterine smooth‑muscle cells. This dual stimulation raises intracellular calcium and activates contractile pathways, producing a sustained contraction of the myometrium that assists in controlling postpartum bleeding.

The dose of Mitrotan is determined by the prescribing clinician based on the clinical situation, patient weight, and route of administration. Healthcare professionals follow local guidelines and product labeling to select an appropriate regimen for each individual case.

Mitrotan is intended for use after delivery to manage postpartum hemorrhage or uterine atony. It is not used during pregnancy, and safety during breastfeeding has not been established. Clinicians should evaluate the risk‑benefit profile for each patient.

To order Mitrotan, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and import documentation.

Oxytocin is the first‑line uterotonic for most deliveries, acting via oxytocin receptors. Mitrotan (ergometrine maleate) works through serotonergic and adrenergic pathways, offering a potent contractile effect that can be useful when oxytocin alone is insufficient or when rapid hemostasis is required. Both agents have distinct safety profiles that guide their use.

Mitrotan should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme temperature fluctuations to maintain its stability and potency.

Mitrotan is supplied as an injectable solution for intramuscular or intravenous administration. The route and rate of injection are selected by the treating clinician, typically in a controlled obstetric setting where vital signs can be monitored.

Serious risks include coronary artery spasm, myocardial ischemia, and anaphylactic reactions, all of which can be life‑threatening. Prompt recognition and emergency management are essential if these events occur during or after administration.

Mitrotan is contraindicated in patients with known hypersensitivity to ergot alkaloids, uncontrolled hypertension, significant coronary artery disease, or peripheral vascular disorders. It should also be avoided in individuals receiving other potent vasoconstrictive agents unless specifically directed by a qualified physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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