
MIF200 mg
Renata Limited
Mifepristone is a progesterone receptor antagonist with two distinct, approved indications that use different strengths and dosing regimens: 1.
Mifepristone is a progesterone receptor antagonist with two distinct, approved indications that use different strengths and dosing regimens:
Mifepristone (200 mg) is indicated, in a regimen together with misoprostol, for medical termination of an intrauterine pregnancy through 70 days (10 weeks) of gestation, calculated from the first day of the last menstrual period. Mifepristone alone is not adequate for reliable termination and must be followed by misoprostol as directed within an approved protocol.
Mifepristone (300 mg strength) is indicated 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. This indication uses a markedly different, chronic daily-dosing regimen and is unrelated to the pregnancy-termination use.
Use of Mifepristone for menstrual regulation or early pregnancy management outside approved combination regimens and outside licensed, monitored programs is not recommended; it should be used only under direct medical supervision within an approved protocol.
| Step | Regimen |
|---|---|
| Day 1 | Mifepristone 200 mg taken orally as a single dose. |
| 24-48 hours later | Misoprostol administered as directed per approved protocol, unless expulsion has already occurred. |
| Follow-up | Clinical or ultrasound confirmation of complete termination approximately 7-14 days after Mifepristone administration is required. |
| Parameter | Regimen |
|---|---|
| Starting dose | Mifepristone 300 mg orally once daily, taken with a meal. |
| Titration | May be increased gradually based on clinical and glycemic response, without exceeding the maximum dose specified in approved product labeling. |
| Duration | Continued long-term as prescribed, with regular monitoring. |
Mifepristone must only be dispensed and administered under the supervision of a qualified physician within an approved, monitored program; for the pregnancy-termination indication, patients must have access to emergency care throughout treatment. See Precautions and Warnings.
Common effects with the pregnancy-termination regimen include vaginal bleeding/spotting (an expected effect), uterine cramping, nausea, vomiting, diarrhea, headache, dizziness, and fever/chills. With the Cushing's syndrome regimen, common effects include fatigue, nausea, headache, low blood potassium, joint pain, vomiting, peripheral swelling, and endometrial thickening or abnormal vaginal bleeding due to the antiprogestin effect.
Serious but less common effects include heavy or prolonged vaginal bleeding, infection, and incomplete termination requiring further intervention. Seek urgent medical care for heavy bleeding, fever lasting more than 24 hours, severe abdominal pain, or signs of infection after taking Mifepristone.
Other cautions, such as the need for follow-up and bleeding monitoring, are precautions rather than absolute contraindications; see Precautions and Warnings.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.