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Mifepristone (generic)

Active Ingredient:
Mifepristone
Form:
TABLET
Brand:
Mifepristone
Origin:
USA

Mifepristone (generic) (Mifepristone TABLET) 200 mg/1

Mifepristone is an FDA-approved oral medication indicated for the treatment of hyperglycemia associated with Cushing's Syndrome. It is a glucocorticoid receptor antagonist that has received orphan drug designation for this rare endocrine disorder. This medication represents an important therapeutic option for managing the metabolic complications of Cushing's Syndrome.

Strength

200 mg/1

Pack Size

1 TABLET in 1 BLISTER PACK (84670-014-01)

Manufacturer / TM Owner

Generic

1
Pack/s
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Indications & Clinical Uses

  • Mifepristone is used to treat hyperglycemia in patients with Cushing's Syndrome, a rare endocrine disorder characterized by excessive cortisol production. The drug functions as a glucocorticoid receptor antagonist, blocking the effects of excess cortisol at the receptor level rather than reducing cortisol production itself. This mechanism makes it particularly valuable for patients who cannot undergo surgery or in whom other treatments have failed. The target patient population includes adults with confirmed Cushing's Syndrome experiencing significant hyperglycemia and metabolic dysfunction. By antagonizing glucocorticoid receptors, mifepristone helps normalize glucose metabolism and reduce insulin resistance caused by chronic cortisol excess. The drug is especially beneficial for patients with ectopic ACTH syndrome or adrenocortical carcinoma where surgical intervention is not feasible. Treatment typically improves glycemic control and reduces diabetes-related complications in this vulnerable patient population.

Side Effects

  • Common side effects of mifepristone include nausea, fatigue, headache, and abdominal discomfort. Serious adverse events may include hypokalemia, hypertension, and adrenal insufficiency due to unopposed glucocorticoid receptor blockade. Patients may experience vaginal bleeding or endometrial changes. Regular monitoring of serum potassium, blood pressure, and glucose levels is essential. Adrenal function assessment and cortisol levels should be periodically evaluated. Patients require close clinical supervision, particularly during treatment initiation and dose adjustments to manage potential complications effectively.

Precautions & Warnings

  • Mifepristone is contraindicated in patients with confirmed or suspected pregnancy due to its abortifacient properties and teratogenic potential. It should be used with caution in patients with hepatic or renal impairment, as dose adjustments may be necessary. Patients with hypokalemia, hypertension, or cardiac arrhythmias require careful monitoring. The drug is not recommended in pediatric populations due to limited safety data. Women of childbearing potential must use effective contraception during treatment. Patients with a history of adrenal insufficiency require additional monitoring. Concurrent use with certain medications affecting potassium levels or blood pressure warrants careful oversight and potential dose modification.

Avoid Interactions

  • Mifepristone may interact with medications metabolized by CYP3A4, including certain antifungals, macrolide antibiotics, and protease inhibitors, potentially increasing mifepristone levels. Concurrent use with potassium-sparing diuretics or NSAIDs increases hyperkalemia risk. Medications affecting blood pressure may have enhanced effects. St. John's Wort may reduce mifepristone efficacy through CYP3A4 induction. Grapefruit juice should be avoided as it inhibits CYP3A4 metabolism. Patients should inform healthcare providers of all medications and supplements to prevent clinically significant interactions.

Frequently Asked Questions

Mifepristone is used to treat hyperglycemia (elevated blood sugar) in patients with Cushing's Syndrome, a rare endocrine disorder caused by excessive cortisol production. It works by blocking glucocorticoid receptors, reducing the metabolic effects of excess cortisol. This medication is particularly useful for patients who cannot undergo surgery or have failed other treatments.

Mifepristone is administered orally as a tablet. The dosage is individualized based on patient response and tolerability, typically starting at a lower dose and titrating upward as needed. Treatment requires regular medical monitoring and dose adjustments to optimize glycemic control while minimizing adverse effects.

Common side effects include nausea, fatigue, headache, and abdominal discomfort. Some patients may experience vaginal bleeding or endometrial changes. Serious side effects can include hypokalemia, hypertension, and adrenal insufficiency, requiring close medical monitoring during treatment.

Mifepristone is available as a generic medication from multiple manufacturers. Various pharmaceutical companies produce generic formulations of this drug for the treatment of Cushing's Syndrome-related hyperglycemia.

Yes, mifepristone has received FDA orphan drug designation for the treatment of Cushing's Syndrome. This designation recognizes it as a medication for a rare disease affecting a small patient population, providing regulatory incentives for its development and approval.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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