G-Ergometrine0.2 mg/ml

G-Ergometrine is an ergot alkaloid uterotonic (oxytocic) agent used exclusively in the postpartum or post-abortion period to control uterine bleeding. It is never used before delivery of the fetus.

Established/Approved Uses

• Prevention of postpartum hemorrhage (PPH): given routinely as part of active management of the third stage of labor, immediately after delivery of the placenta.
• Treatment of postpartum hemorrhage due to uterine atony: used to produce sustained uterine contraction when the uterus fails to contract adequately after delivery.
• Postpartum or post-abortion uterine subinvolution: used to promote involution of the uterus and reduce lochia/bleeding after delivery or abortion.

Adjunct/Combination Use

G-Ergometrine is frequently used as an adjunct together with oxytocin, or after oxytocin has been given, when additional or more sustained uterotonic effect is required for hemorrhage control.

Off-Label Use

Historically, G-Ergometrine (as ergonovine) has been used in a specialized cardiology diagnostic test (the ergonovine/ergometrine provocation test) to help diagnose coronary artery vasospasm; this is an off-label, specialist-only use performed under strict cardiac monitoring and is not relevant to its routine obstetric use.

Each mL of Ergometrine Maleate injection contains Ergometrine Maleate BP/USP 0.2 mg (200 micrograms) in Water for Injection. Tablet formulations, where marketed, typically contain Ergometrine Maleate 0.2 mg per tablet. Strength and available dosage forms may vary by manufacturer; refer to the product label for exact composition.

G-Ergometrine is a semi-synthetic ergot alkaloid belonging to the oxytocic (uterotonic) class of drugs. It is derived from ergot, a fungus that grows on rye and related grains, and acts directly on uterine smooth muscle to produce strong, sustained contractions.

G-Ergometrine is used clinically in the immediate postpartum or post-abortion period to prevent and treat excessive uterine bleeding caused by a poorly contracting uterus (uterine atony), and to support normal uterine involution after delivery. It is supplied mainly as an injection (intramuscular or intravenous) for use in hospital and clinical delivery settings, with oral tablets available in some markets for short-course postpartum use.

G-Ergometrine belongs to the ergot alkaloid class of drugs and is classified therapeutically as an oxytocic (uterotonic) agent used in obstetric care for control of postpartum bleeding.

Ergometrine Maleate acts directly on uterine smooth muscle. Unlike oxytocin, which produces rhythmic contractions, Ergometrine Maleate causes a rapid, forceful, and sustained (tetanic) contraction of the uterus. This markedly reduces blood flow through the myometrial vessels and helps control bleeding at the placental implantation site after delivery.

The uterus becomes increasingly sensitive to the stimulant action of Ergometrine Maleate as pregnancy progresses to term, which is why the drug is only used after delivery of the fetus and placenta, never before.

Ergometrine Maleate also has weak alpha-adrenergic agonist and partial 5-HT (serotonin) receptor agonist activity, which accounts for its vasoconstrictive effects on peripheral and coronary blood vessels and its potential to raise blood pressure, particularly with intravenous administration.

Onset of action: IM approximately 2-5 minutes; IV almost immediate. Duration: approximately 3 hours (IM) or 45 minutes (IV) of sustained uterine tone.

• For IM use, inject into a large muscle (e.g., anterolateral thigh or deltoid) using aseptic technique.
• For IV use (emergency hemorrhage only), give as a slow injection over at least 60 seconds, with continuous blood pressure and pulse monitoring, because rapid IV administration can cause a sudden, dangerous rise in blood pressure and stroke.
• G-Ergometrine is never given before delivery of the fetus and placenta.
• Inspect the ampoule visually; do not use if the solution is discolored or contains particulate matter.

Clinically Significant Interactions

• Potent CYP3A4 inhibitors (e.g., macrolide antibiotics such as erythromycin and clarithromycin, azole antifungals such as ketoconazole/itraconazole, HIV protease inhibitors): can raise G-Ergometrine blood levels and precipitate acute ergotism, with severe peripheral vasospasm and ischemia. Concurrent use should be avoided.
• Other ergot alkaloids (e.g., ergotamine, methylergometrine): additive vasoconstrictive and hypertensive effects; concurrent use should be avoided.
• Other vasoconstrictors/sympathomimetic agents (e.g., vasopressors used for regional anesthesia, decongestants): may add to the hypertensive effect of G-Ergometrine, increasing the risk of severe hypertension.
• Regional anesthetics containing vasoconstrictors: combined use has been associated with severe, sudden hypertension and stroke; use with caution and monitor blood pressure.

Common

• Nausea and vomiting
• Headache
• Abdominal pain/uterine cramping
• Transient elevation in blood pressure
• Dizziness

Less Common/Serious

• Marked hypertension, palpitations, chest pain
• Tinnitus, ringing in the ears
• Shortness of breath
• Peripheral vasospasm (cold, numb, or pale extremities)

Rare but Serious

• Seizures, stroke, or myocardial infarction related to severe vasospasm/hypertension, reported mainly with rapid intravenous use
• Allergic/hypersensitivity reactions

Report any severe headache, chest pain, or numbness/coldness of the hands and feet to a physician immediately.

Pregnancy

G-Ergometrine must never be used during pregnancy or before delivery of the fetus and placenta; it is used solely in the postpartum/post-abortion period (see Contraindications). Its potent uterotonic effect on the pregnant uterus can cause fetal distress and uterine rupture.

Lactation

G-Ergometrine passes into breast milk in small amounts and, particularly with repeated or prolonged dosing, has been associated with reduced milk production (through suppression of prolactin) and rare reports of ergotism-like symptoms (vomiting, diarrhea, weak pulse, unstable blood pressure) in breastfed infants. A single postpartum dose is generally considered acceptable with breastfeeding, but repeated or extended dosing should be used only if clearly needed, and the potential benefit should be weighed against potential risk to the infant; consult a physician and monitor the infant for feeding difficulty or unusual symptoms.

• G-Ergometrine should be administered only by, or under the direct supervision of, a trained healthcare professional in a clinical/hospital delivery setting.
• Use with caution in patients with hepatic or renal impairment, as drug clearance may be reduced and the risk of toxicity increased.
• Use with caution in patients with a history of migraine, Raynaud's phenomenon, or other vasospastic conditions, given the vasoconstrictive action of the drug.
• Monitor blood pressure closely, especially after intravenous administration, due to the risk of sudden severe hypertension.
• Avoid concurrent use with potent CYP3A4 inhibitors and other vasoconstrictive/ergot agents (see Interactions).
• Discontinue immediately and seek medical attention if signs of ergotism (numbness, tingling, or coldness of extremities, muscle pain, chest pain) occur.
• Not intended for chronic outpatient use; treatment course is short and confined to the immediate postpartum period.

Overdose or excessive dosing of G-Ergometrine can cause acute ergotism, presenting as severe hypertension, headache, seizures, chest pain, and peripheral vasospasm (cold, numb, or painful extremities due to reduced blood flow). Nausea, vomiting, and confusion may also occur.

Suspected overdose is a medical emergency. Seek immediate medical attention or contact emergency services/a poison control center. Management is supportive and must be carried out under medical supervision (e.g., blood pressure control, treatment of vasospasm); do not attempt to manage a suspected overdose at home.

Store in a refrigerator (2°C-8°C), protected from light. Do not freeze. If refrigeration is not available, follow the manufacturer's specific storage instructions on the pack, as potency declines with storage at higher temperatures. Keep out of reach of children.

Pediatric Use

G-Ergometrine has no indication in children; it is used exclusively in postpartum or post-abortion women. Safety and efficacy in the pediatric population have not been established.

Elderly

Not applicable, as G-Ergometrine is used only in women in the reproductive age group in the immediate postpartum/post-abortion period.

Hepatic Impairment

Use with caution; reduced hepatic metabolism may increase the risk of ergotism-type toxicity. See Precautions and Warnings.

Renal Impairment

Use with caution and under close medical supervision, as reduced clearance may increase systemic exposure.

G-Ergometrine is used for a short duration around childbirth: typically a single dose immediately after delivery of the placenta for prevention of hemorrhage, with additional doses over the following hours if needed to control ongoing atony, and, where oral tablets are used for subinvolution, a short course of up to about one week postpartum. It is not intended for long-term or chronic use.

Ergot alkaloid; Oxytocic (uterotonic) agent

Ergometrine Maleate acts directly on uterine smooth muscle (myometrium) to produce a rapid, powerful, and sustained contraction, which compresses the blood vessels at the placental implantation site and reduces postpartum bleeding. It also exerts mild alpha-adrenergic agonist and serotonergic vasoconstrictive effects on blood vessels, which underlie its potential to raise blood pressure and, in overdose, to cause vasospastic ischemia.

G-Ergometrine is not used in children. It has no pediatric indication; its sole clinical use is in postpartum or post-abortion women to control uterine bleeding, and safety and efficacy in pediatric patients have not been established.