This kit is indicated for early menstrual regulation (MR) or termination of pregnancy up to 9 weeks (63 days) of gestation.

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity. It works by competitively binding to progesterone receptors and blocking the action of progesterone. Studies in animals show that it inhibits the effect of both endogenous and exogenous progesterone, leading to menstrual regulation (MR). During pregnancy, it increases the sensitivity of the myometrium to prostaglandins, enhancing uterine contractions.

Misoprostol: Misoprostol is a synthetic prostaglandin E1 analogue. It acts on specific receptors in the uterine muscle (myometrium), causing changes in calcium levels that trigger muscle contraction. It also softens the cervix and stimulates uterine contractions, resulting in expulsion of uterine contents.

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 cheek & 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.

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: history of allergy or hypersensitivity to Mifepristone, Misoprostol or prostaglandins; confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; presence of IUD; chronic adrenal failure; haemorrhagic disorders or concurrent anticoagulant therapy; inherited porphyria; and lack of access to emergency medical facilities for management of complications, blood transfusion or resuscitation during treatment.

Mifepristone: The treatment is intended to induce vaginal bleeding and uterine cramping. Common side effects include nausea, vomiting, and diarrhea. Less commonly reported effects include pelvic pain, dizziness, headache, fainting, and asthenia.

Misoprostol: Common side effects include diarrhea, abdominal pain, nausea, vomiting, flatulence, dyspepsia, headache, constipation, shivering, fever, dizziness, and uterine contraction pain. Severe effects may include heavy vaginal bleeding, shock, pelvic pain, and rarely uterine rupture requiring surgical intervention.

Pregnancy: Mifepristone is indicated for menstrual regulation up to 63 days of pregnancy and has no other approved use during pregnancy. Ongoing pregnancy after treatment may result in fetal malformation, and surgical termination is recommended in such cases.

Lactation:

• It is unknown whether Mifepristone is excreted in breast milk, although similar hormones are known to pass into milk. Breastfeeding women should consult a physician and may need to temporarily discard breast milk.
• Misoprostol is also not recommended during breastfeeding due to potential excretion of its active metabolite, which may cause diarrhea in infants.

The patient should not share Mifepristone & Misoprostol with anyone else. It is prescribed for a specific condition and may be dangerous if used by others, especially during pregnancy. Any intrauterine device (IUD) must be removed before starting treatment. If the treatment fails, surgical Menstrual Regulation (MR) is recommended. Ongoing pregnancy after treatment may lead to fetal malformation, and surgical termination/MVA is recommended in such cases.

Hepatic Impairment: Patients with liver disease should receive a reduced dose of Misoprostol.
Renal Impairment: No routine adjustment is required, but dose reduction may be needed if not tolerated.

Mifepristone: No serious adverse effects were observed even at doses higher than three times the recommended dose. Massive overdose may require monitoring for signs of adrenal insufficiency.

Misoprostol: Overdose symptoms may include sedation, tremor, convulsions, shortness of breath, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Treatment is supportive. Dialysis is not effective due to its metabolism.

Drugs acting on the Uterus, Prostaglandin analogues

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