Mifepristone + Misoprostol

Termination of early unwanted pregnancy up to 63 days (9 weeks)

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins. Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

Patient will take 1 (one) Mifepristone Tablet orally After 24 hours, patient will take 4 (four) Misoprostol tablets sublingually After 10-14th days, patient will confirm her termination of pregnancy by ultrasonography

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Confirmed or suspected ectopic pregnancy IUD in place Chronic adrenal failure History of allergy to Mifepristone, Misoprostol or other prostaglandin Hemorrhagic disorders or concurrent anticoagulant therapy

Commonly reported side effects were nausea, vomiting and diarrhea.

It is indicated for use in the termination of pregnancy (through 63 days$#$#$#$ pregnancy) and has no other approved indication for use during pregnancy. It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure. Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.

Each box contains 2 blister strips. One strip contains 1 tablet of Mifepristone INN 200 mg. Another strip contains 4 tablets of Misoprostol USP 200 microgram each.