Description

Ergometrine Tablets (0.125mg / 0.2mg / 0.5mg)

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 specialized Manufacturer of Ergometrine Maleate Tablets in India. Ergometrine (also known as Ergonovine) is a critical Uterotonic agent derived from ergot fungus. It is a life-saving drug used primarily in obstetrics for the prevention and treatment of Postpartum Hemorrhage (PPH) caused by uterine atony. It works by causing sustained contractions of the uterus, effectively clamping down on bleeding vessels after delivery.

We offer Contract Manufacturing (Third Party) services for this highly sensitive emergency medicine. Ergometrine is notoriously unstable and degrades rapidly when exposed to light or heat. Our WHO-GMP certified facility in Mumbai utilizes specialized Dark Room Manufacturing protocols and cold-chain-compatible packaging to ensure potency. Healthy Inc manages the export logistics, supplying government maternity hospitals and rural health clinics across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Handling a volatile molecule with care.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Light Protection: Ergometrine turns dark and loses potency within minutes of light exposure. We manufacture this product under Sodium Vapor Lamps (Yellow Light) to prevent photo-degradation during compression and packing.

  • Stability Enhancement: We use Maleic Acid during granulation to maintain an acidic micro-environment within the tablet, which significantly improves the stability of the Ergometrine salt.

  • Coating: We apply a robust Sugar Coating or Opaque Film Coating to provide a final barrier against light and oxidation.

• The Exporter: Healthy Inc

  • Cold Chain Logistics: While the tablet is more stable than the injection, we still recommend and support Temperature Controlled Shipping (Reefer Containers) to ensure the product arrives with full potency, especially for tenders in hot climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products (Ergometrinine) which are inactive and potentially toxic.

• Dissolution: We ensure rapid release (>75% in 45 mins) so the drug can act quickly to stop bleeding.

5. Why Use Ergometrine?

Stops the bleeding when the uterus won’t contract.

• Mechanism: Ergometrine acts directly on the Alpha-Adrenergic and Serotonin (5-HT2) receptors of the uterine smooth muscle. This stimulates forceful, rhythmic contractions of the upper and lower segments of the uterus. By compressing the spiral arteries in the placental bed, it mechanically stops bleeding.

• Key Indications:

  • Postpartum Hemorrhage (PPH): Treatment of excessive bleeding after childbirth due to a “boggy” or relaxed uterus.

  • Post-Abortion Hemorrhage: To control bleeding after miscarriage or surgical abortion.

  • Incomplete Abortion: To help expel retained products of conception (rarely used now; Misoprostol is preferred).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air (Cold Chain) or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Ergometrine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it the same as Methylergometrine?

  A: Very Similar. Methylergometrine (Methergine) is a semi-synthetic derivative with slightly longer action, but Ergometrine is the classic, natural alkaloid. Both are used for the same purpose.

• Q: Does it need a fridge?

  A: Ideally, Yes. While tablets are stable at room temperature for short periods, long-term storage in a refrigerator (2-8°C) is highly recommended to maintain full potency.

• Q: Is it safe for breastfeeding?

  A: Caution. It can pass into breast milk and may suppress lactation (reduce milk supply). It should only be used if absolutely necessary to control bleeding.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• PPH Prevention/Treatment: 0.2mg to 0.4mg orally, 2-4 times daily for 2 days.

• Onset: Acts within 5-10 minutes (Oral).

• Administration: Swallow whole.

9. Side Effects and Precautions

• Cardiovascular: Hypertension (High BP), palpitations, chest pain. Contraindicated in women with pre-eclampsia or eclampsia.

• Gastrointestinal: Nausea and vomiting are common.

• Ergotism: Prolonged use can cause gangrene of extremities (rare with short courses).

• Pain: Strong “after-pains” (cramps) due to uterine contraction.

10. Storage Instructions

• Store between 2°C and 8°C (Refrigerator).

• Protect from light. (Light destroys this drug).