In the pharmaceutical industry, Ergometrine Maleate (also known as Ergonovine) is a potent ergot alkaloid used specifically in obstetrics. As a pharmacist and manufacturer, I view its administration through the lens of emergency uterine management: its dosing is strictly controlled because of its powerful vasoconstrictive properties and potential for systemic toxicity.

At your WHO-GMP facility in Mumbai, where you likely produce the 0.2 mg or 0.5 mg tablets and injections, maintaining clear dosing limits is a vital technical safety barrier for your maternal health portfolio.

Standard Dosing Protocols

The number of doses depends entirely on the clinical objective and the route of administration:

Mechanism: Selective Myometrial Stimulation

Direct Contraction: Unlike Oxytocin, which produces rhythmic contractions, Ergometrine induces a tetanic (sustained) contraction of the uterine muscle.

Compression: This intense contraction compresses the blood vessels (sinuses) at the placental site, effectively “clamping” the bleed.

Onset: The injection works in 1–2 minutes (IV) or 5–7 minutes (IM), whereas tablets take much longer to reach therapeutic levels.

The Pharmacist’s “Technical Warning”

• The “Hypertension” Contraindication: Ergometrine is strictly forbidden for patients with pre-eclampsia, eclampsia, or high blood pressure. It can cause a sudden, dangerous spike in BP leading to a stroke or heart attack.

• The “Ergotism” Risk: If the maximum number of doses is exceeded (more than 1 week of oral use), patients may experience Ergotism (St. Anthony’s Fire)—intense vasoconstriction in the fingers and toes leading to gangrene.

• Breastfeeding Warning: Ergometrine inhibits prolactin and can significantly reduce breast milk production. It should not be used routinely if the mother intends to nurse.

• Store Cold: As a manufacturer, you know that Ergometrine injections are highly heat-sensitive. They must be stored between 2°C and 8°C and protected from light; otherwise, the API degrades rapidly.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Cold Chain” USP: On your digital marketplace, emphasize your validated cold-chain shipping for Ergometrine injections. This is the primary concern for B2B buyers in tropical climates like Africa or SE Asia.

• Stability for Export: For the tablet form, utilizing Alu-Alu blister packaging with desiccant is essential to prevent the API from oxidizing and losing potency in Zone IVb regions.

• Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration in international maternal health and emergency medicine tenders.