Mifepristone Agreement

Although specific interactions with Mifepristone have not been studied, depending on the metabolism of this drug, CYP 3A4 may inhibit the metabolism of ketoconazole, itraconazole, erythromycin and grapefruit juice (increased serum mifepriston concentrations). MIFEPREX should be used with caution in patients currently or recently treated with CYP 3A4 inhibitors. Information on frequent adverse events is based solely on data from U.S. studies, as rates have been reported in non-U.S. studies. The studies were much lower and are probably not generalized for the American population. In three U.S. clinical trials, a total of 1,248 women per 70 days of pregnancy, Mifepriston 200 mg followed orally 24-48 hours later by misoprostol 800 mcg buccally, women reported side effects in diaries and interviews during the visit. In these studies, healthy women were generally added to the reproductive age without contraindications for mifepristone or misoprostol according to the MIFEPREX product label.

Safety and efficacy data from oral Mifepristone 200 mg clinical trials followed 24-48 hours later of misoprostol 800 MCG buccally during 70 days of pregnancy are reported below. Success has been defined as the complete designation of design products without surgery. Table 3 presents overall failure and success rates based on 22 global clinical studies (including 7 U.S. trials). Patients and methods: between 2 January 2003 and 7 July 2004, 433 women were admitted for a medical abortion 7 weeks ago. All pre-abortion consultations and 2 weeks after the abortion took place in a private provider office. The drugs were administered at the hospital`s family planning clinic: patients received 3 mifepriston tablets (600 mg) orally from the midwife and received 2 misoprostol tablets (400 microg) which they would take 48 hours later at home. In the event of problems or complications, patients can call or meet with their private providers, call a hospital midwife or go to the hospital emergency department. Private providers have received training in the field of medical abortion and have been able to contact a specialist at the hospital`s family planning clinic at any time for information or information from a patient. Here you can use genBioPro (generic) and Danco (brands, Mifeprex) forms that doctors should use when using abortion drugs with mifepriston. Based on information on in vitro inhibition, the concomitant administration of mifepriston may result in an increase in serum concentrations of CYP 3A4 substrate drugs. Due to the slow elimination of mifepriston from the body, such interaction can be observed for an extended period after administration.

Caution is therefore recommended when mifepriston is administered with drugs that are substrates of CYP 3A4 and have a narrow therapeutic area. Mifeprex (MIF-eh-prex) (Mifepriston) tablets, Oral use In terological studies in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than 1/100 to about 1/3 human exposure to body surface), due to Mifeprstein`s antiprogesic activity, fetal losses were much higher than in control animals. Cranial deformities have been observed in rabbit studies at about 1/6 of human exposure, although no teratogenic effects of Mifepristone have been observed in rats or mice.