Mifepristone Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Abortion

Day 1: three 200 mg tablets (600 mg total) orally administered as a single, one time dose.

Day 3: the patient returns to the health care provider 2 days after mifepristone ingestion. Unless termination of pregnancy has been confirmed via clinical examination or ultrasonographic scan upon follow-up visit, the patient is given two 200 mcg tablets (400 mcg total) of MISOPROSTOL orally, administered as a single dose one time. The patient then returns 14 days after administration of mifepristone to confirm complete termination of early pregnancy.

Usual Adult Dose for Cushing's Syndrome

To control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery:

The recommended starting dose is 300 mg orally once daily with a meal.
The daily dose may be increased in 300 mg increments not more frequently than once every 2 to 4 weeks. The dose may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day.
If treatment is interrupted, it should be reinitiated at the lowest dose (300 mg).

Renal Dose Adjustments

For termination of early pregnancy: Data not available.

For hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery: The maximum dose should be limited to 600 mg.

Liver Dose Adjustments

For termination of early pregnancy: Data not available.

For hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery: in mild to moderate hepatic impairment the maximum dose should be limited to 600 mg. Mifepristone should not be used in severe hepatic impairment.

Precautions

Mifepristone should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome.

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone used for termination of early pregnancy. It includes a Medication Guide, elements to assure safe use, and implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Treatment with mifepristone and misoprostol for the termination of pregnancy requires 3 office visits by the patient. Mifepristone should be prescribed only by physicians who have read and understood the prescribing information. Mifepristone may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitations, if necessary.

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