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 an oral tablet for oral use. It is used for the medical termination of intra‑uterine pregnancy up to 10 weeks gestation.

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 is a progesterone receptor antagonist employed in early pregnancy termination.

  • Medical termination of intrauterine pregnancy up to 10 weeks gestation: induces decidual breakdown and facilitates expulsion of the gestational sac.
  • Pre‑treatment before misoprostol in medical abortion protocols: enhances the efficacy of the prostaglandin analogue used to complete the abortion.
  • Early intrauterine pregnancy up to 7 weeks: provides a medically supervised option for termination within the approved gestational window.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the endometrium, blocking the hormone's action. This antagonism leads to decidual degeneration, detachment of the gestational sac, and increased uterine sensitivity to prostaglandins, thereby facilitating medical termination when followed by a prostaglandin analogue such as misoprostol.

Side Effects

Mifegyne may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Vaginal bleeding: spotting or heavier flow.
  • Abdominal cramping: uterine contractions.
  • Diarrhea: loose stools.
  • Fatigue: general tiredness.
  • Headache: mild pain in the head.

Serious or Rare Side Effects

  • Severe infection: signs of fever or sepsis.
  • Heavy bleeding: excessive blood loss requiring medical attention.
  • Allergic reaction: rash, swelling, or difficulty breathing.
  • Liver dysfunction: jaundice or abnormal liver tests.
  • Uterine rupture: rare but life‑threatening emergency.
  • Persistent gestational sac: incomplete abortion requiring surgical intervention.

Precautions & Warnings

Mifegyne should be used only under qualified medical supervision with attention to specific safety considerations.

  • Confirm gestational age: ensure pregnancy is ≤10 weeks.
  • Medical supervision: procedure must be overseen by a trained health professional.
  • Contraindications: avoid in chronic adrenal failure, long‑term corticosteroid therapy, anticoagulant use, or intrauterine device presence.
  • Allergy assessment: do not use if hypersensitivity to mifepristone or any excipients is known.
  • Drug interaction review: evaluate concomitant medications that may affect efficacy or safety.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mifegyne can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce mifepristone effectiveness.
  • Anticoagulants (e.g., warfarin, heparin): increase risk of significant bleeding.

Moderate Interactions (Monitor Closely)

  • Misoprostol: required for complete abortion; timing and dosing must be coordinated.
  • Hormonal contraceptives: may diminish contraceptive efficacy after abortion.
  • NSAIDs: can exacerbate gastrointestinal discomfort.
  • Antifungal azoles (e.g., ketoconazole): may increase mifepristone plasma levels.
  • Antidepressants (e.g., sertraline): monitor for additive nausea or dizziness.

Frequently Asked Questions

Mifegyne contains mifepristone and is used for the medical termination of intra‑uterine pregnancy up to 10 weeks gestation. It works together with a prostaglandin analogue, usually misoprostol, to induce uterine expulsion of the gestational sac under clinical supervision.

Mifepristone acts as a progesterone receptor antagonist. By blocking progesterone’s action in the endometrium, it causes decidual breakdown and detachment of the gestational sac, making the uterus more responsive to prostaglandins that trigger uterine contractions and expulsion of pregnancy tissue.

The specific dose and regimen of Mifegyne are determined by the prescribing clinician based on gestational age, patient health, and local medical guidelines. Only a qualified health professional can set the appropriate dosage and timing for each individual case.

Mifegyne is intended to end an existing early pregnancy and is therefore not used to treat conditions during pregnancy. It is contraindicated in ongoing pregnancy beyond the approved gestational limit and should not be used while breastfeeding, as safety data are lacking.

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

Mifegyne (mifepristone) is the most widely used progesterone receptor antagonist for early medical abortion and is typically combined with misoprostol. Alternative regimens may use misoprostol alone, which can be less effective and require higher doses. Mifegyne offers a higher success rate and a shorter treatment course when used as recommended.

Mifegyne should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Maintaining these conditions preserves the tablet’s stability and potency throughout its shelf life.

Mifegyne is taken orally as a single tablet under medical supervision. After ingestion, misoprostol is usually administered buccally, sublingually, or vaginally within a specified time frame to complete the abortion process.

Serious risks include heavy or uncontrolled bleeding, severe infection, allergic reactions, and, in rare cases, uterine rupture or incomplete abortion requiring surgical intervention. Patients should be monitored closely and seek immediate medical attention if any severe symptoms develop.

Mifegyne is contraindicated in individuals with chronic adrenal failure, long‑term corticosteroid therapy, anticoagulant use, intra‑uterine device in place, known hypersensitivity to mifepristone, or pregnancy beyond 10 weeks gestation. It should also be avoided in patients with certain severe medical conditions as determined by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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