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 oral tablet for oral use. It is employed to prevent and treat postpartum hemorrhage and uterine atony in the obstetric setting. It is indicated for use in women after delivery when uterine contraction is insufficient, helping to reduce blood loss and stabilize hemodynamics.

GNH India supplies Mitrotan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides reliable logistics for global distribution.

Manufacturer / TM Owner

Gap S.A.

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Indications & Clinical Uses

Ergometrine maleate is used as a uterotonic to stimulate uterine smooth‑muscle contraction in obstetric care.

  • Postpartum hemorrhage: reduces excessive bleeding by inducing sustained uterine contraction after delivery.
  • Uterine atony: restores tone in a relaxed uterus during or after childbirth.
  • Cesarean section uterine control: helps achieve hemostasis by contracting the uterus intra‑operatively.

How It Works

  • Ergometrine maleate acts as a partial agonist at serotonin (5‑HT2), dopamine and alpha‑adrenergic receptors in uterine smooth muscle. Activation of these receptors triggers intracellular calcium influx, leading to sustained contraction of the myometrium. The combined serotonergic and adrenergic stimulation reinforces uterine tone, thereby limiting postpartum blood loss. The drug’s affinity for multiple receptor subtypes produces a synergistic effect that is more potent than stimulation of a single pathway, ensuring reliable uterine contractility even in cases of refractory atony.

Side Effects

Ergometrine maleate may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild gastrointestinal upset.
  • Headache: transient cranial discomfort.
  • Hypertension: temporary increase in blood pressure.
  • Abdominal cramping: uterine pain.

Serious or Rare Side Effects

  • Severe hypertension: risk of hypertensive crisis.
  • Cardiac arrhythmia: irregular heart rhythm.
  • Pulmonary edema: fluid accumulation in lungs.

Precautions & Warnings

When prescribing Mitrotan, clinicians should observe several safety considerations.

  • Assess cardiovascular status: evaluate blood pressure before administration.
  • Monitor for uterine hyperstimulation: watch for excessive contractions.
  • Use with caution in patients with pre‑eclampsia: risk of worsening hypertension.
  • Avoid in known hypersensitivity to ergot alkaloids: may trigger allergic reactions.
  • Review concomitant vasoconstrictive drugs: potential additive effects.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light.

Avoid Interactions

Ergometrine maleate can interact with several medication classes.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): can cause severe hypertension.
  • Ergot‑derived vasoconstrictors (e.g., ergotamine): additive vasospasm risk.
  • Sympathomimetic agents (e.g., epinephrine): may precipitate hypertensive emergencies.

Moderate Interactions (Monitor Closely)

  • Antihypertensive medications: may blunt desired blood pressure rise.
  • Calcium channel blockers: potential for altered uterine response.
  • Antidepressants affecting serotonin (SSRIs): monitor for serotonergic effects.

Frequently Asked Questions

Mitrotan contains ergometrine maleate and is used as a uterotonic to prevent and treat postpartum hemorrhage and to manage uterine atony after delivery. By stimulating sustained uterine contractions, it helps reduce excessive bleeding in the obstetric setting.

Ergometrine maleate acts as a partial agonist at serotonin (5‑HT2), dopamine and alpha‑adrenergic receptors in the uterine smooth muscle. This multi‑receptor activation increases intracellular calcium, producing a strong and lasting contraction of the myometrium that limits postpartum blood loss.

The dose of Mitrotan is determined by the prescribing clinician based on the patient’s clinical condition, severity of hemorrhage, and local treatment protocols. Healthcare professionals should follow the recommended dosing guidelines provided in the product’s prescribing information.

Mitrotan is intended for use after delivery; it is not recommended for use during pregnancy because uterine stimulation before birth could be harmful. Limited data are available for breastfeeding, so clinicians should weigh potential risks and benefits before prescribing to nursing mothers.

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 and any necessary import documentation.

The primary alternative uterotonic is oxytocin, which is a peptide administered intravenously or intramuscularly. Mitrotan, an oral ergot alkaloid, offers a different route of administration and a longer duration of uterine contraction, but it carries a higher risk of vasoconstrictive side effects compared with oxytocin.

Mitrotan tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Mitrotan is supplied as oral tablets and should be taken by mouth with a glass of water. The tablet is swallowed whole; it is not intended to be crushed, chewed, or dissolved unless specifically directed by a healthcare professional.

The most serious adverse events associated with Mitrotan include severe hypertension, cardiac arrhythmias, and pulmonary edema. Patients should be monitored closely for sudden spikes in blood pressure, irregular heart rhythms, or respiratory distress, and treatment should be stopped if these events occur.

Mitrotan is contraindicated in individuals with known hypersensitivity to ergot alkaloids, uncontrolled hypertension, pre‑eclampsia, or those currently taking monoamine oxidase inhibitors. It should also be avoided in patients with severe cardiovascular disease where additional vasoconstriction could be dangerous.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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