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 employed for the medical termination of early pregnancy up to ten weeks gestation and for cervical ripening prior to surgical procedures.

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 regulatory support for global distribution.

Manufacturer / TM Owner

Exelgyn Sa

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Indications & Clinical Uses

Mifepristone acts on progesterone‑dependent pathways and is indicated for the following clinical situations:

  • Medical termination of early pregnancy (up to 10 weeks gestation): induces abortion by disrupting progesterone support of the gestational sac.
  • Cervical ripening prior to surgical procedures: facilitates cervical softening to aid dilation and evacuation.
  • Cushing's syndrome (in combination therapy): contributes to reduction of cortisol production when used with other agents.

How It Works

  • Mifepristone binds competitively to progesterone receptors in the uterus, blocking the hormone’s action. This antagonism leads to decidual breakdown, detachment of the gestational sac, and increased uterine contractility. In combination regimens for Cushing’s syndrome, it also antagonizes glucocorticoid receptors, reducing cortisol‑mediated effects.

Side Effects

Mifepristone may cause a range of adverse reactions, which are grouped by frequency and severity.

Common Side Effects

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

Serious or Rare Side Effects

  • Severe infection: signs of sepsis or fever.
  • Heavy hemorrhage: excessive blood loss requiring medical intervention.
  • Allergic reaction: rash, swelling, or anaphylaxis.

Precautions & Warnings

Before prescribing Mifegyne, clinicians should consider several safety and handling precautions.

  • Confirm gestational age: ensure pregnancy is ≤10 weeks by ultrasound.
  • Evaluate for ectopic pregnancy: rule out before use.
  • Assess for chronic corticosteroid therapy: avoid abrupt discontinuation.
  • Monitor for anemia: check hemoglobin due to potential bleeding.
  • Counsel on contraception: advise effective contraception after treatment.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Mifepristone can interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce mifepristone plasma levels, compromising effectiveness.
  • Anticoagulants (e.g., warfarin): increased risk of bleeding when combined with abortion‑related hemorrhage.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise mifepristone concentrations, heightening side‑effect risk.
  • NSAIDs: may exacerbate gastrointestinal discomfort.
  • Hormonal contraceptives: reduced efficacy when used concurrently; advise backup method.

Frequently Asked Questions

Mifegyne is used primarily for the medical termination of early intrauterine pregnancy up to ten weeks gestation and for cervical ripening before surgical procedures such as dilation and evacuation. In some regions it is also part of combination therapy for Cushing’s syndrome.

Mifepristone works by binding competitively to progesterone receptors in the uterus, blocking progesterone’s action. This causes the decidua to break down, the gestational sac to detach, and uterine contractility to increase, leading to termination of pregnancy. It also blocks glucocorticoid receptors when used for Cushing’s syndrome.

The exact dose of Mifegyne is determined by the prescribing clinician based on the indication, gestational age and local guidelines. Typically a single oral tablet is administered, often followed by misoprostol, but the prescriber sets the regimen and timing.

Mifegyne is contraindicated in an ongoing pregnancy beyond the approved gestational window and should not be used during breastfeeding without medical supervision. Women are advised to avoid breastfeeding until the drug is cleared from their system, as safety data are limited.

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, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

The most common alternative for early medical abortion is methotrexate, which works by inhibiting cell division. Mifepristone directly blocks progesterone receptors, leading to a faster and more predictable abortion process when combined with misoprostol, whereas methotrexate requires a longer treatment period and has a different side‑effect profile.

Mifegyne tablets should be stored at ambient temperature, below 25 °C, in their original blister pack or container. Protect them from moisture and direct sunlight. Keep out of reach of children and do not use if the packaging is damaged.

Mifegyne is taken as an oral tablet. The tablet should be swallowed whole with a glass of water; it should not be chewed, crushed or split. Administration is usually performed in a clinical setting under medical supervision.

Serious risks include heavy hemorrhage requiring medical intervention, severe infection or sepsis, and allergic reactions such as rash, swelling or anaphylaxis. Patients should seek immediate medical attention if they experience excessive bleeding, fever, severe abdominal pain or signs of an allergic response.

Mifegyne should not be used in women with confirmed or suspected ectopic pregnancy, chronic adrenal insufficiency, severe anemia, uncontrolled bleeding disorders, or those taking anticoagulant therapy without careful monitoring. It is also contraindicated in individuals with known hypersensitivity to mifepristone.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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