Ergometrine Maleate

Ergometrine Maleate is an oral and parenteral ergot alkaloid. Ergometrine maleate is used in the active management of the third stage of labour, and to prevent or treat postpartum or postabortal haemorrhage caused by uterine atony; by maintaining uterine contraction and tone, blood vessels in the uterine wall are compressed, and blood flow reduced.

Ergometrine Maleate’s innovator is Novartis-Global and is known by the brand name Methergin.

The pharmacologic properties of the ergot alkaloids are complex; some of the pharmacologic actions are unrelated to each other; some actions are even mutually antagonistic. Ergometrine Maleate is a selective and potent antagonist of serotonin receptors in various smooth muscles, a partial agonist of serotonin receptors in human umbilical and placental blood vessels, and a partial agonist and antagonist in some areas of the CNS. Ergometrine Maleate is also a partial agonist of alpha-adrenergic receptors in blood vessels. The normal response of the coronary arteries in response to the ergot alkaloids is coronary vasospasm and a resultant decrease in luminal diameter.

Clinically, Ergometrine Maleate increases the strength, duration, and frequency of uterine contractions and decreases uterine bleeding. Ergometrine Maleate is considered a second-line agent for uterine atony, Ergometrine Maleate stimulates the upper and lower segments for stronger uterine tone. Endpoints of therapeutic effect include the onset of uterine contractions and the cessation of hemorrhaging following obstetric delivery. The drug may increase blood pressure or induce vasospasm in therapeutic use, but rarely does the drug cause serious cardiovascular or cerebral responses.

Ergometrine Maleate appears in the following formulation and dosage:
Capsules: 0.125 mg
Injectable: 0.2 mg/ml
Oral Solution: 0.25 mg/ml
Tablets: 0.125 and 0.2 mg

General data on Ergometrine Maleate Active Pharmaceutical Ingredient

CAS Registry: 129-51-1
ATC: G02AB03
Molecular Formula: C19H23N3O2, C4H4O4
Molecular Weight: 441.5
Pharmacopoeias: In Chin., Eur., Int., Jpn, and US.

Ph. Eur. 5.5: Ergometrine Maleate is a white or slightly coloured crystalline powder. Ergometrine Maleate is sparingly soluble in water; slightly soluble in alcohol. A 1% solution in water has a pH of 3.6 to 4.4.

USP 30: Ergometrine Maleate Maleate is a white to greyish-white or faintly yellow, odourless, microcrystalline powder. It darkens with age and on exposure to light. Ergometrine Maleate is sparingly soluble in water; slightly soluble in alcohol; insoluble in chloroform and in ether.

TAPI's Ergometrine Maleate Pharmaceutical Ingredient

TAPI's Ergometrine Maleate Active Pharmaceutical Ingredient is produced in IVAX Pharmaceuticals s.r.o. in Opava-Komarov, Czech Republic.

Ergometrine Maleate is produced by TAPI by Semi - Synthetic synthesis and considered to be low volume Active Pharmaceutical Ingredient.
 
2008 Available DMF: U.S. DMF, EU CTD and CEP.

TAPI provide full service on Ergometrine Maleate and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Ergometrine Maleate. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Ergometrine Maleate.

Other products, in the group of OBSTETRIC PREPARATIONS - Ergot Alkaloids available on TAPI's portfolio are: Ergotamine Tartrate and Methylergonovine Maleate. Contact us today for information on these products.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients