Mifepristone

Mifepristone (Mifeprex) is an oral tablet that may be used with misoprostol tablets to end a pregnancy that is 10 weeks or less (70 days or less since the start of your last period). Another brand of mifepristone called Korlym may be used to treat high blood sugar caused by high cortisol levels in adults with Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or cannot have surgery. For this use, mifepristone is given daily, and females must avoid becoming pregnant. Mifepristone should not be used by people with type 2 diabetes mellitus that is not caused by Cushing’s syndrome. Mifepristone was first FDA-approved on September 28, 2000, as the brand Mifeprex. Korlym was FDA-approved on February 17, 2012. Generic mifepristone is available.

Mifepristone (Mifeprex) is an oral tablet that may be used with misoprostol tablets to end a pregnancy that is 10 weeks or less (70 days or less since the start of your last period). Another brand of mifepristone called Korlym may be used to treat high blood sugar caused by high cortisol levels in adults with Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or cannot have surgery. For this use, mifepristone is given daily, and females must avoid becoming pregnant. Mifepristone should not be used by people with type 2 diabetes mellitus that is not caused by Cushing’s syndrome. Mifepristone was first FDA-approved on September 28, 2000, as the brand Mifeprex. Korlym was FDA-approved on February 17, 2012. Generic mifepristone is available.

Some women should not take mifepristone (Mifeprex) to terminate a pregnancy, including women who: have a pregnancy that is more than 70 days (10 weeks). Your healthcare provider may do a clinical examination, an ultrasound examination, or other testing to determine how far along you are in pregnancy are using an IUD (intrauterine device or system). It must be taken out before you take mifepristone have been told by your healthcare provider that you have a pregnancy outside the uterus (also called an ectopic pregnancy) are allergic to mifepristone, misoprostol, Mifeprex, Korlym, Cytotec, or Arthrotec have problems with their adrenal glands (chronic adrenal failure). take a medicine to thin your blood, such as dabigatran or warfarin have a bleeding problem have porphyria take certain steroid medicines. Tell your healthcare provider if you: cannot follow up within approximately 7 to 14 days of your first visit are breastfeeding are taking medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements (see interactions below). Ask your healthcare provider if you are not sure about all your medical conditions before taking mifepristone.

C ommon side effects of mifepristone when used to terminate a pregnancy are: feeling sick (nausea) feeling tired or weak cramping vaginal bleeding fever/chills vomiting headache diarrhea dizziness. If you are not already bleeding from your vagina after taking mifepristone, you will begin to bleed once you take misoprostol. Bleeding or spotting can be expected for an average of 9 to 16 days and may last up to 30 days. Your bleeding may be similar to, or greater than, a normal heavy period. You may see blood clots and tissue. This is an expected part of passing the pregnancy. The combination of mifepristone and misoprostol often causes cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms. Mifepristone carries a Boxed Warning for serious and sometimes fatal infections and bleeding. Serious and sometimes fatal infections and bleeding are rare when mifepristone is used to terminate a pregnancy, but it is important to know that these can happen. In certain circumstances, serious bacterial infections can present without symptoms typical of an infection, for example, without fever or without shaking, chills, or gastrointestinal symptoms. Cramping and vaginal bleeding are expected with this treatment. Usually, these symptoms mean the treatment is working. But sometimes you may get cramping and bleeding but still be pregnant. Prolonged heavy bleeding may be a sign of an incomplete abortion or other complications and further medical or surgical intervention may be required. Contact your healthcare provider right away if you have: Heavy bleeding , especially if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C) Abdominal pain , abdominal discomfort, or “feeling sick”, including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking mifepristone. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb) A high fever (100.4°F or higher) that lasts for more than 4 hours. Fever may be a symptom of a serious infection or another problem. If you cannot reach your healthcare provider for any of these problems, go to the nearest hospital emergency room. Take your mifepristone (Mifeprex) Medication Guide with you or tell them that you have recently taken medicine to terminate a pregnancy. Rhesus immunization . Using mifepristone requires the same preventive measures as those taken before and during surgical abortion to prevent rhesus immunization. When used for a medical abortion, mifepristone is not approved for ending pregnancies that are further along than 10 weeks. These are not all the possible side effects of mifepristone when used to terminate a pregnancy. Call your healthcare provider for medical advice about any side effects that bother you or do not go away. You may report side effects to the FDA at 1-800-FDA-1088.

Mifepristone should not be given to patients with chronic adrenal failure, hemorrhagic disorders or those receiving anticoagulants or long term corticosteroid therapy, impaired liver or kidney function. It should be used with caution in patients with chronic obstructive air way disease, asthma or cardiovascular disease. It is not recommended to use during pregnancy.

Drug should not be given to Pediatrics, Pregnant Mothers, patients suffering from Kidney dysfunction, patients suffering from Liver Malfunction, Geriatrics, and Neonates. If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

12 mg/kg (12 (12)) As recommended. PO — Once Scraped Dose — The usual dosage of mifepristone and misoprostol to terminate a pregnancy is mifepristone 200 mg (1 tablet) on Day 1, followed 24 to 48 hours later by misoprostol 800 mcg (four 200 mcg tablets), which is placed in the cheek pouch (buccally). The mifepristone tablet is swallowed whole. The misoprostol tablets are placed in the cheek pouch (buccally). This means you put them between your top lip and gum. Place 2 misoprostol tablets in one cheek pouch and two in the other. Leave them there for 30 minutes and then swallow anything left over with a drink of water or another liquid. The medicines may not work as well if you do not follow your healthcare provider's instructions properly.

( ) — Not recommended in this age group

( ) — Not recommended in this age group

Mifepristone is known to interact with other drugs, the details of drug interactions is as follows:DrugDetailsSeverityOnsetManagementAspirinDeflazacortErgometrine (Maleate)Oral contraceptive increase platelet aggregability and promote thrombus formationModeratesimultaneous use of ergometrine with oral contraceptives should be avoidedGemeprostTenoxicamTenoxicam should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Tab Store in a well closed container, at room temperature.