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Mifepristone + Misoprostol is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Composition:

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.

Pharmacology:

Mifepristone: Mifepristone is a synthetic steroid with anti-pregestational 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.

Dosage & Administration:

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical

Intervention/MVA (Manual Vacuum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue).

She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms.

The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone.

This visit is very important to confirm by clinical examination or ultrasonographic 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 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.

Contraindications:

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the

Side Effects:

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Precautions & Warnings:

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 fetal malformation resulting from the treatment.

Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Use in Special Populations:

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Overdose Effects:

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, diarrhea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy.

Therapeutic Class: Drugs acting on the Uterus, Prostaglandin analogues

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