Description

Methylergonovine Tablets (0.125mg)

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 Methylergonovine Maleate Tablets in India. This semi-synthetic Ergot Alkaloid is a critical emergency drug used in obstetrics for the prevention and treatment of Postpartum Hemorrhage (PPH) and Post-Abortal Hemorrhage. It acts directly on the smooth muscle of the uterus to increase tone, rate, and amplitude of rhythmic contractions, effectively stopping bleeding after delivery.

We offer Contract Manufacturing (Third Party) services for this potent uterotonic. Methylergonovine is highly sensitive to light and heat, which can cause it to lose potency rapidly. Our WHO-GMP certified facility in Mumbai utilizes specialized Low-Actinic Light Suites (amber lighting) for processing and advanced sugar/film coating technologies to ensure the tablet remains stable and effective when it is needed most. Healthy Inc manages the export logistics, supplying maternity hospitals and government health ministries across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stability is the difference between life and death in PPH cases.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Photosensitivity Control: The maleate salt turns brown and loses potency if exposed to light. We manufacture the entire batch under Sodium Vapor Lamps and use opaque coating materials to create a light-proof barrier around the core.

  • Content Uniformity: Since the dose is extremely small (0.125mg), we use Geometric Dilution during blending to ensure the active ingredient is perfectly distributed, preventing sub-therapeutic or toxic doses.

  • Cold Storage: The finished product is stored in temperature-controlled warehouses (2°C – 8°C or <25°C depending on zone stability data) prior to shipping.

• The Exporter: Healthy Inc

  • Protective Packaging: We exclusively recommend Alu-Alu Cold Form Blisters or light-resistant Amber Blisters. Clear PVC is risky for export markets due to light exposure during retail.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: Rapid release is required to stop bleeding quickly. We test release profiles to ensure >70% release in 30 minutes.

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

• Appearance: Any discoloration (browning) of the tablet core indicates degradation; such batches are rejected immediately.

5. Why Use Methylergonovine?

It provides “Tetanic” contractions to seal blood vessels.

• Mechanism: It stimulates the alpha-adrenergic and serotonin receptors on the uterine smooth muscle. Unlike Oxytocin (which produces rhythmic contractions), Methylergonovine produces a sustained, firm contraction (tetanic) that compresses the blood vessels in the uterine wall, mechanically stopping the bleeding.

• Key Indications:

  • Postpartum Hemorrhage: Treatment of uterine atony (failure of the uterus to contract) after the placenta is delivered.

  • Subinvolution: Used to help the uterus return to its normal size (involution) after childbirth.

  • Post-Abortion: Control of hemorrhage following abortion or miscarriage.

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 or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Methylergonovine Tablets?

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

• Q: Is it Methergine?

  A: Methergine is the brand name (Novartis). We manufacture the Generic Equivalent (Methylergonovine Maleate), which contains the exact same active ingredient.

• Q: Can it be used to induce labor?

  A: ABSOLUTELY NOT. It causes sustained, powerful contractions that can cut off oxygen to the baby or rupture the uterus. It is only used after the baby is born.

• Q: Can I breastfeed while taking it?

  A: Caution advised. Small amounts pass into breast milk and can reduce milk supply or cause side effects in the infant. Consult a doctor.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 0.125mg (one tablet) orally, 3 or 4 times daily.

• Duration: Usually given for a maximum of 1 week postpartum.

• Administration: Swallow whole.

9. Side Effects and Precautions

• Hypertension: Significant Risk. It constricts blood vessels and can cause a sharp rise in blood pressure. Contraindicated in women with pre-eclampsia, eclampsia, or chronic high blood pressure.

• Coronary Spasm: Can cause chest pain (angina) in susceptible patients.

• Ergotism: Overdose can cause nausea, vomiting, and numbness in fingers/toes (due to vasoconstriction).

10. Storage Instructions

• Refrigerate if possible (2°C – 8°C) for long-term storage.

• For short-term (patient use): Store below 25°C, strictly protected from light.