Product image of Mifegyne (Mifepristone) supplied by GNH India

Mifegyne

Active Ingredient:
Mifepristone
Origin:
EU

Mifegyne (Mifepristone)

Mifepristone, the active ingredient in Mifegyne, is a progesterone receptor antagonist presented as a 200 mg tablet for oral use. It treats medical termination of intrauterine pregnancy up to 9 weeks gestation and is also used in early pregnancy loss, uterine fibroids, and Cushing's syndrome.

GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

Mifepristone is a progesterone receptor antagonist used in several reproductive and endocrine indications.

  • Medical termination of intrauterine pregnancy (up to 9 weeks gestation): induces decidual breakdown and embryo detachment.
  • Early pregnancy loss: facilitates expulsion of retained products of conception.
  • Uterine fibroids: reduces fibroid size and associated symptoms.
  • Cushing's syndrome: lowers cortisol production when combined with glucocorticoid receptor antagonists.

How It Works

  • Mifepristone acts as a competitive antagonist at progesterone receptors, preventing progesterone binding and maintaining the decidua. This blockade leads to decidual breakdown, cervical softening, and detachment of the embryo. In endocrine disorders such as Cushing's syndrome, the drug also blocks glucocorticoid receptors, decreasing cortisol activity and reducing expression of progesterone‑regulated genes.

Side Effects

Mifepristone may cause a range of adverse reactions, which are generally categorized as common or serious.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Vaginal bleeding: irregular or heavy bleeding.
  • Cramping: uterine cramping or abdominal pain.
  • Fatigue: feeling of tiredness.

Serious or Rare Side Effects

  • Heavy hemorrhage: excessive blood loss requiring medical intervention.
  • Severe infection: signs of sepsis or pelvic infection.
  • Allergic reaction: rash, itching, swelling, or anaphylaxis.
  • Liver dysfunction: elevated liver enzymes or jaundice.

Precautions & Warnings

Mifepristone requires careful clinical assessment before use.

  • Confirm gestational age: ensure pregnancy is ≤9 weeks before use.
  • Conduct pre‑treatment evaluation: assess for ectopic pregnancy, anticoagulant use, or uterine abnormalities.
  • Use in combination therapy: follow with a prostaglandin analogue as recommended.
  • Monitor for infection: watch for fever, pelvic pain, or foul discharge.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Mifepristone can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • CYP3A4 inducers: such as rifampicin may reduce plasma levels.
  • Anticoagulants: increased risk of bleeding when combined with warfarin.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles: may increase mifepristone exposure.
  • Antihypertensives: potential alteration of blood pressure control.
  • Hormonal contraceptives: may reduce effectiveness of contraceptive methods.

Frequently Asked Questions

Mifegyne contains mifepristone and is used primarily for the medical termination of intrauterine pregnancy up to nine weeks gestation. It is also indicated for the management of early pregnancy loss, reduction of uterine fibroid size, and as part of therapy for Cushing's syndrome when combined with other agents.

Mifepristone works by competitively blocking progesterone receptors, which are essential for maintaining the uterine lining during early pregnancy. This antagonism causes decidual breakdown, cervical softening, and detachment of the embryo, facilitating expulsion. In endocrine disorders, it also blocks glucocorticoid receptors, reducing cortisol activity.

The specific dose of Mifegyne is determined by the prescribing clinician based on the indication, gestational age, and local treatment protocols. Typically, a single 200 mg oral tablet is used for early pregnancy termination, but the exact regimen should always follow the prescriber's instructions.

Mifegyne is contraindicated in ongoing pregnancy except when used for its approved indication of medical termination. It should not be used by women who are breastfeeding, as mifepristone can be excreted in breast milk and may affect the infant. Consultation with a healthcare professional is essential.

To order Mifegyne, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

The most common alternative in medical abortion regimens is misoprostol, a prostaglandin analogue that induces uterine contractions. Mifepristone initiates the process by antagonising progesterone, while misoprostol completes it by causing expulsion. Using both sequentially provides higher efficacy than misoprostol alone.

Mifegyne tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect from moisture and light. Keep the product out of reach of children and avoid storing in areas with high humidity or direct sunlight.

Mifegyne is taken orally as a single tablet. The patient should swallow the 200 mg tablet whole with water, following any specific instructions from the prescriber regarding timing relative to other medications such as prostaglandin analogues.

Serious risks include heavy hemorrhage requiring medical intervention, severe infection or sepsis, allergic reactions that may progress to anaphylaxis, and liver dysfunction indicated by elevated enzymes or jaundice. Patients should be monitored closely for these signs and seek immediate medical attention if they occur.

Mifegyne should not be used by individuals with known hypersensitivity to mifepristone, those with chronic adrenal failure, patients on long‑term corticosteroid therapy, women with ectopic pregnancy, or anyone for whom pregnancy exceeds nine weeks gestation. Contraindications also include severe uncontrolled asthma and certain cardiovascular conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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