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 10 weeks gestation and is also used off‑label for management of 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

  • Mifegyne (mifepristone) is employed in reproductive health and endocrine conditions where progesterone antagonism is required.
  • Medical termination of intrauterine pregnancy up to 10 weeks gestation: induces decidual breakdown and facilitates uterine expulsion.
  • Medical abortion in combination with misoprostol: provides the initial pharmacologic step before prostaglandin‑mediated uterine contractions.
  • Management of Cushing's syndrome (off‑label): blocks peripheral progesterone receptors and contributes to cortisol reduction when used with other agents.

How It Works

  • Mifepristone binds competitively to progesterone receptors, preventing progesterone from maintaining the decidua. This antagonism leads to breakdown of the uterine lining and detachment of the embryo. The drug also sensitizes uterine smooth muscle to prostaglandins, enhancing the contractile response when a prostaglandin analogue such as misoprostol is administered.

Side Effects

Mifegyne may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea
  • Vomiting
  • Abdominal pain or cramping
  • Diarrhea
  • Fatigue
  • Headache

Serious or Rare Side Effects

  • Heavy or prolonged vaginal bleeding
  • Infection (including sepsis)
  • Severe allergic reaction (anaphylaxis)
  • Liver injury (hepatotoxicity)
  • Uterine rupture
  • Deep vein thrombosis or pulmonary embolism

Precautions & Warnings

  • Mifegyne should be used only under qualified medical supervision with appropriate patient assessment.
  • Medical supervision: administration must be overseen by a qualified health professional.
  • Gestational age verification: ensure pregnancy is ≤10 weeks before use.
  • Contraindications: avoid in patients with adrenal insufficiency, chronic corticosteroid therapy, anticoagulant use, severe anemia, or an intrauterine device in place.
  • Allergy: do not use if hypersensitivity to mifepristone or any tablet excipients.
  • Drug interactions: review concomitant medications, especially anticoagulants and CYP inducers.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Mifegyne can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased risk of severe bleeding.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine): reduced efficacy of mifepristone.
  • Systemic corticosteroids: may blunt intended hormonal effects.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may increase gastrointestinal discomfort.
  • Antihypertensives: monitor blood pressure for unexpected changes.
  • Antifungal azoles (e.g., ketoconazole): may raise plasma levels of mifepristone.

Frequently Asked Questions

Mifegyne contains mifepristone and is approved for the medical termination of intrauterine pregnancy up to 10 weeks gestation. It is also employed off‑label for the management of Cushing's syndrome when combined with other hormonal agents.

Mifepristone competitively blocks progesterone receptors in the uterus, causing the decidua to break down and the embryo to detach. By sensitising the uterus to prostaglandins, it also enhances uterine contractions when a prostaglandin analogue such as misoprostol is given.

The specific dose of Mifegyne is determined by the prescribing clinician based on the indication, gestational age and local protocol. In most approved regimens a single 200 mg oral tablet is administered, but the exact schedule must be confirmed by a qualified health professional.

Mifegyne is contraindicated in ongoing pregnancy beyond the intended medical termination and is classified as Pregnancy Category X. It is also not recommended for breastfeeding mothers because the drug can be excreted in breast milk and may affect the infant.

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

The primary alternative for early medical abortion is methotrexate, which works by inhibiting cell division rather than blocking progesterone receptors. Mifegyne provides a faster onset of action and is typically used in combination with misoprostol, offering a more predictable and shorter treatment course compared with methotrexate‑based protocols.

Mifegyne tablets should be stored at ambient temperature below 25 °C, in their original packaging, and protected from moisture and direct sunlight. Keep the product out of reach of children and avoid exposing it to excessive heat or humidity.

Mifegyne is taken orally as a single tablet with water under direct medical supervision. After the initial dose, a prostaglandin analogue such as misoprostol is usually prescribed to complete the abortion process, following the clinician’s specific protocol.

Serious risks include heavy or prolonged vaginal bleeding, infection leading to sepsis, severe allergic reactions, liver injury, uterine rupture and thromboembolic events. Patients should seek immediate medical attention if they experience signs of these complications.

Mifegyne should not be used by individuals with known adrenal insufficiency, chronic corticosteroid therapy, anticoagulant treatment, severe anemia, an intrauterine device in place, or a confirmed allergy to mifepristone or any tablet excipients. It is also contraindicated in pregnancies beyond 10 weeks gestation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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