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 oral tablet for oral use. It is employed for the medical termination of intrauterine pregnancy up to ten weeks gestation and for the medical management of early pregnancy loss in women.

GNH India supplies Mifegyne as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution, ensuring product integrity throughout the supply chain.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

  • Mifepristone is a progesterone receptor antagonist used in reproductive health for early pregnancy termination and management.
  • Medical termination of intrauterine pregnancy up to 10 weeks gestation: induces uterine expulsion of the gestational sac.
  • Medical management of early pregnancy loss: facilitates evacuation of retained products of conception.

How It Works

  • Mifepristone selectively binds to progesterone receptors in the uterus, blocking the action of endogenous progesterone. This antagonism leads to decidual breakdown, detachment of the gestational sac, and increased uterine sensitivity to prostaglandins, thereby promoting expulsion of pregnancy tissue when used in conjunction with a prostaglandin analogue.

Side Effects

Mifepristone may cause a range of adverse reactions.

Common Side Effects

  • Nausea
  • Vomiting
  • Abdominal pain or cramping
  • Vaginal bleeding or spotting
  • Diarrhea
  • Fatigue

Serious or Rare Side Effects

  • Severe hemorrhage requiring medical intervention
  • Infection (septic abortion)
  • Allergic reaction including anaphylaxis
  • Incomplete abortion necessitating surgical evacuation

Precautions & Warnings

Before prescribing Mifegyne, clinicians should consider several safety measures.

  • Confirm gestational age ≤10 weeks: verify by ultrasound.
  • Assess for ectopic pregnancy: rule out before use.
  • Screen for contraindications: chronic adrenal failure, long‑term corticosteroid therapy, anticoagulant use.
  • Obtain informed consent: discuss risks, benefits, and alternatives.
  • Monitor for excessive bleeding: ensure follow‑up visit within 48–72 hours.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Mifegyne can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Anticoagulants (warfarin, direct oral anticoagulants): increase risk of hemorrhage.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (ketoconazole, erythromycin): may increase plasma levels.
  • NSAIDs: may mask bleeding symptoms.
  • Misoprostol: used in combination regimen; timing must be coordinated.

Frequently Asked Questions

Mifegyne is used for the medical termination of intrauterine pregnancy up to ten weeks gestation and for the medical management of early pregnancy loss. It works as part of a regimen that typically includes a prostaglandin analogue to complete the evacuation of pregnancy tissue.

Mifepristone blocks progesterone receptors in the uterus, preventing progesterone from maintaining the pregnancy. This leads to breakdown of the decidua, detachment of the gestational sac, and increased uterine sensitivity to prostaglandins, which together facilitate expulsion of the pregnancy when a prostaglandin is administered.

The specific dose of Mifegyne is determined by the prescribing clinician based on the patient’s clinical situation and local guidelines. In most protocols a single 200 mg oral tablet is administered, but the exact regimen should be confirmed by a qualified health professional.

Mifegyne is contraindicated in ongoing pregnancy beyond the approved indication and is classified as Pregnancy Category X, meaning it should not be used during pregnancy for any other purpose. It is also not recommended for breastfeeding women because it may pass into breast milk and affect the infant.

To order Mifegyne, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any required temperature control) and import documentation.

The most common alternative to Mifegyne is a regimen based on methotrexate, which also terminates early pregnancy but works by inhibiting cell division rather than blocking progesterone. Mifepristone generally provides a faster onset of action and is often combined with misoprostol, offering a higher efficacy rate for pregnancies up to ten weeks.

Mifegyne tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect them 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 tablet should be swallowed whole with a glass of water under medical supervision. It is usually followed by a prostaglandin analogue (such as misoprostol) taken according to a prescribed schedule to complete the abortion process.

The most serious risks include severe hemorrhage that may require transfusion or surgical intervention, infection leading to septic abortion, and incomplete abortion that necessitates further medical or surgical management. Patients should be instructed to seek immediate medical attention if they experience heavy bleeding, fever, or severe abdominal pain.

Mifegyne should not be used by individuals with confirmed or suspected ectopic pregnancy, chronic adrenal insufficiency, long‑term corticosteroid therapy, anticoagulant therapy, or known hypersensitivity to mifepristone or any of its excipients. It is also contraindicated in women who are beyond ten weeks gestation or who are pregnant for reasons other than the approved indication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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