Ergometrine Tablets

Description

Ergometrine Maleate Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a manufacturer of Ergometrine Maleate Tablets in India. Ergometrine, also known as ergonovine, is an ergot alkaloid with uterotonic activity. It increases uterine smooth-muscle tone and may be used in selected obstetric settings for prevention or treatment of bleeding associated with uterine atony according to the approved product label and current clinical guidance.

Postpartum hemorrhage is a medical emergency. Choice of uterotonic medicine, route and timing depends on the clinical situation, contraindications and available protocols; an oral tablet should not be presented as a substitute for emergency assessment or faster-acting treatment when those are required.

2. Product Specifications

3. Manufacturing Technology

• Light & Stability Control: Ergometrine is sensitive to environmental conditions. Lighting, temperature, humidity and processing controls should be established through product-specific development and validation rather than assuming a universal dark-room or sodium-vapor-lamp process.
• Formulation Control: pH-modifying excipients or other stabilization approaches may be used only where they are part of the validated registered formulation.
• Protective Coating: Sugar or opaque film coating may provide handling and light-protection benefits where supported by the actual product design.
• Packaging: Light- and moisture-protective packaging is selected using stability data. Refrigerated transport should only be claimed when required by the registered storage conditions.

4. Quality Assurance

• Assay & Uniformity: Potency and dosage-unit uniformity are tested using validated methods and applicable acceptance criteria.
• Related Substances: Relevant degradation products, including ergometrine-related isomers/impurities where applicable, are controlled according to the registered specification.
• Dissolution: Drug release is tested using the applicable registered method; a universal >75% in 45 minutes requirement should not be assumed.
• Stability: Shelf life, storage temperature and packaging are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Ergometrine produces strong uterine smooth-muscle contraction through complex actions involving serotonergic, adrenergic and other receptor systems. Its vasoconstrictor activity also contributes to important cardiovascular precautions.

• Postpartum Uterine Atony / Hemorrhage: May be used in selected patients according to local obstetric protocols and approved labeling.
• Post-Abortion Bleeding: May be used for uterine bleeding associated with inadequate uterine contraction when clinically appropriate.
• Not Routine Self-Treatment: It should not be used by patients to manage heavy bleeding without urgent medical assessment.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where available for the specific product.
• Certificates: FSC, COPP and COA where applicable.
• Packaging & Shipping: Shipment conditions follow the registered storage requirements and validated transport approach.
• Logistics: Air or sea shipment via FOB Mumbai / CIF where appropriate.

7. Frequently Asked Questions

Q: Who manufactures Ergometrine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Ergometrine Maleate tablet formulations in India.

Q: Is Ergometrine the same as Methylergometrine?
A: No. They are related ergot uterotonics but are distinct active substances and should not be treated as automatically interchangeable. Product selection and dosing must follow the exact medicine and local prescribing information.

Q: Does the tablet always need refrigeration?
A: Storage requirements depend on the exact registered formulation and market label. Protecting ergometrine from light and excessive heat is important, but a universal 2–8°C requirement should not be applied unless specified for that product.

Q: What about breastfeeding?
A: Ergot uterotonics may affect lactation and can expose a breastfed infant. Use during breastfeeding should follow the exact prescribing information and clinician assessment.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Clinician-Directed Use: Dose, route, frequency and duration depend on the indication, severity of bleeding, blood pressure, comorbidities and local obstetric protocol. A universal oral regimen should not be applied.
• Emergency Bleeding: Postpartum hemorrhage requires immediate clinical management. Oral onset is not sufficiently predictable to replace appropriate emergency uterotonic therapy and supportive care when urgently needed.
• Administration: Use the tablet only according to the registered product instructions and prescriber direction.

9. Side Effects and Precautions

• Cardiovascular: Hypertension, vasoconstriction, chest pain, palpitations and ischemic complications can occur. Blood-pressure status and cardiovascular contraindications are important.
• Hypertensive Disorders of Pregnancy: Ergometrine is generally avoided or contraindicated in pre-eclampsia, eclampsia and significant hypertension according to prescribing guidance.
• Gastrointestinal / Neurologic: Nausea, vomiting, abdominal pain, headache and dizziness may occur.
• Ergot Toxicity: Excessive exposure can cause severe vasoconstriction and ischemic complications. Use should be limited to the clinically appropriate dose and duration.
• Interactions: Potent CYP3A4 inhibitors and other vasoconstrictive medicines may increase risk with ergot alkaloids; interaction guidance should follow the exact product label.

10. Storage Instructions

• Store at the temperature stated on the registered product label.
• Protect from light and excessive heat and moisture.
• Keep in original protective packaging and out of reach of children.