trasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Interaction

Mifepristone: Although no specific drug or food interaction with mifepristone has been studied, based on the drug's metabolism through CYP 3A4, ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit Its metabolism (increased serum levels of mifepristone.

Misoprostol: Misoprostol has not been proven to interfere with the beneficial effects of aspirin on the signs and symptoms of rheumatoid arthritis. Misoprostol has no clinically significant effect on the absorption of therapeutic doses of aspirin, blood levels, and antiplatelet effects.

Contraindications

Mifepristone is contraindicated in patients with any of the following conditions: history of known allergy or hypersensitivity to mifepristone, misoprostol, or other prostaglandins, confirmed or suspected ectopic pregnancy, or undiagnosed adnexal mass (the treatment procedure cannot effectively terminate the ectopic pregnancy ) pregnancy), placement of an intrauterine contraceptive device, chronic adrenal insufficiency, bleeding disorders or simultaneous anticoagulant therapy, hereditary porphyria, if the patient has been since the first visit to the treating physician was discharged from the hospital.

Side Effects

Mifepristone: The treatment program is designed to induce vaginal bleeding and uterine cramps necessary for menstrual regulation (MR). The most common side effects are nausea, vomiting and diarrhea. Pelvic pain, fainting, headache, dizziness, and fatigue are rare.

Misoprostol: gastrointestinal side effects, such as diarrhea, abdominal pain, nausea, flatulence, indigestion, headache, vomiting and constipation, chills, hyperthermia, dizziness, pain caused by uterine contractions, severe vaginal bleeding, shock, pelvis Pain, rupture of the uterus (requires surgical repair). , Hysterectomy and/or salpingo-oophorectomy).

Pregnancy & Lactation

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Precautions & Warnings

Patients should not give the combination of mifepristone and misoprostol to other people. The combination of mifepristone and misoprostol has been prescribed for the specific conditions of the patient, which may not be the correct treatment for others, and may be dangerous to others regardless of pregnancy. Before starting mifepristone treatment, any intrauterine device [IUD] must be removed. In cases where the combination of mifepristone and misoprostol does not cause menstrual regulation (MR), surgical regulation of menstruation (MR) is recommended. Patients who continued to be pregnant at the last visit are at risk of developing fetal malformations due to treatment. It is recommended to manage menstrual regulation (MR) / termination failure through surgical termination / MVA.

Therapeutic Class

Drugs acting on the Uterus, Prostaglandin analogs

Storage Conditions

Store in a cool & dry place. Keep out of reach of children. Do not freeze.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.