A-Kit

Generic

Mifepristone + Misoprostol

Indications

This kit is for early Menstrual Regulation (MR) and pregnancy termination up to 9 weeks (63 days) of pregnancy.

Pharmacology

Mifepristone is a synthetic steroid that has an anti-progestational effect due to its competitive interaction with progesterone at progesterone-receptor sites. The substance inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) outcomes, according to investigations with varied oral doses in several animal species. During pregnancy, the chemical makes the myometrium more sensitive to prostaglandins' contraction-inducing function.

 Misoprostol: Misoprostol is a synthetic prostaglandin E1 analog. It causes the myometrium to contract by interacting with specific receptors on the myometrial cells. This interaction causes a change in calcium concentration, which initiates muscle contraction. By interacting with prostaglandin receptors, misoprostol causes softening of the cervix and contractions of the uterus, thus expelling the contents of the uterus.

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 Vaccum 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 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

ACME Laboratories Ltd.