Indications & Uses
This Mifepristone + Misoprostol kit is used for early Menstrual Regulation (MR), or termination of pregnancy, when the pregnancy has not gone beyond 9 weeks (63 days) of gestation.
Pharmacology
Mifepristone is a synthetic steroid with anti-progestational activity. This comes from its competition with progesterone at the progesterone-receptor sites. In studies using various oral doses in several animal species, the compound inhibited the activity of both endogenous and exogenous progesterone, and Menstrual Regulation (MR) resulted. During pregnancy, it also makes the myometrium more sensitive to the contraction-inducing activity of prostaglandins.
Misoprostol is a synthetic analogue of prostaglandin E1. It acts on specific receptors on myometrial cells, which changes the calcium concentration and starts muscle contraction. Through its action on prostaglandin receptors, misoprostol softens the cervix and makes the uterus contract, so the uterine contents are expelled.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Only a qualified medical professional should prescribe Mifepristone + Misoprostol. This person must be able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. They 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. They must be able to assure the 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 as 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. At 24 to 48 hours after the Mifepristone tablet is taken, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol, buccally or sublingually. She can take the Misoprostol tablets herself, placing two tablets on each side between the cheek and gum, or under the tongue. She should then wait for 30 minutes. Right after taking Misoprostol, she may need medicine for cramps or gastrointestinal symptoms. She should be told what to do if significant discomfort, excessive bleeding or other adverse reactions occur, and she should be given a phone number to call if she has questions after taking 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 taking Mifepristone. This visit is very important, because it confirms by clinical examination or ultrasonographic scan that the termination of pregnancy is complete. Patients who still 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.
Side Effects
Mifepristone: the treatment is meant to cause vaginal bleeding and uterine cramping, which are needed for Menstrual Regulation (MR). The side effects people report most often are nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness and asthenia happen rarely. Misoprostol: gastro-intestinal side effects such as diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, vomiting and constipation can occur. Other effects are headache, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock and pelvic pain. Uterine rupture can also happen, and it may need surgical repair, hysterectomy and/or salpingo-oophorectomy.
Cautions & Contraindications
Warnings & Precautions
The patient should not give the Mifepristone and Misoprostol combination to anyone else. It has been prescribed for the patient's own condition, so it may not be the right treatment for another person. It may also be dangerous for another woman if she is pregnant or becomes pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. If the Mifepristone and Misoprostol combination fails to cause Menstrual Regulation (MR), surgical MR is recommended. Patients whose pregnancy is still ongoing at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage failures of Menstrual Regulation (MR)/termination of pregnancy.
Contraindications
Mifepristone must not be given to a patient who has any one of these conditions: a history of allergy or known hypersensitivity to Mifepristone, Misoprostol or any other prostaglandin, a confirmed or suspected ectopic pregnancy or an undiagnosed adnexal mass (this treatment will not terminate an ectopic pregnancy), an IUD in place, chronic adrenal failure, haemorrhagic disorders or current anticoagulant therapy, or inherited porphyria. It is also contraindicated if the patient does not have adequate access to medical facilities that can give emergency treatment for an incomplete process, blood transfusion and emergency resuscitation, from the first visit until the administering physician discharges her.
Pregnancy & Breastfeeding
Pregnancy: Mifepristone is indicated for Menstrual Regulation (MR) through 63 days of pregnancy, and it has no other approved use during pregnancy. Patients whose pregnancy is still ongoing at the last visit are at risk of foetal malformation from the treatment. Surgical termination is recommended when MR treatment fails.
Lactation: It is not known whether Mifepristone passes into human milk. Many hormones with a similar chemical structure do pass into breast milk, though. Because the effects of Mifepristone on infants are unknown, breast-feeding women should talk to their doctor and decide whether to discard their breast milk for a few days after taking the medicines. For Misoprostol, it is also not known whether it passes into human milk. Even so, it should not be given to nursing mothers, because misoprostol acid could be excreted and cause diarrhoea in the nursing infant.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Use in patients with hepatic impairment: if a patient has liver disease, the dose of Misoprostol should be lower.
Use in patients with renal impairment: no routine dose adjustment of Misoprostol is recommended for older patients or for patients with kidney impairment. The dose may need to be reduced, though, if the usual dose is not tolerated.
Overdose
With Mifepristone, tolerance studies in healthy nonpregnant women and healthy men found no serious adverse reactions. In those studies the subjects took single doses of more than three times the 600mg used for Menstrual Regulation (MR). If a patient swallows a massive overdose, she should be watched closely for signs of adrenal failure.
With Misoprostol, the clinical signs that may point to an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. The symptoms should be treated with supportive therapy. Misoprostol is metabolized like a fatty acid, so dialysis is unlikely to be the right treatment for an overdose.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Mifepristone + Misoprostol in a cool, dry place and away from light.
Drug Interactions
Common questions about Femikit 200 mg+200 mcg
What is Femikit 200 mg+200 mcg Tablet?
Femikit 200 mg+200 mcg Tablet is a medicine that contains Mifepristone + Misoprostol. It is made by Eskayef Pharmaceuticals Ltd. It belongs to the Drugs acting on the Uterus group of medicines.
What is Femikit used for?
This Mifepristone + Misoprostol kit is used for early Menstrual Regulation (MR), or termination of pregnancy, when the pregnancy has not gone beyond 9 weeks (63 days) of gestation.
What are the side effects of Femikit?
Mifepristone: the treatment is meant to cause vaginal bleeding and uterine cramping, which are needed for Menstrual Regulation (MR). The side effects people report most often are nausea, vomiting and diarrhoea.
Can I take Femikit during pregnancy or while breastfeeding?
Pregnancy: Mifepristone is indicated for Menstrual Regulation (MR) through 63 days of pregnancy, and it has no other approved use during pregnancy. Patients whose pregnancy is still ongoing at the last visit are at risk of foetal malformation from the treatment. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Femikit?
With Mifepristone, tolerance studies in healthy nonpregnant women and healthy men found no serious adverse reactions. In those studies the subjects took single doses of more than three times the 600mg used for Menstrual Regulation (MR). In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Femikit?
Keep Mifepristone + Misoprostol in a cool, dry place and away from light.
Can I take other medicines with Femikit?
Some medicines can interact with Mifepristone + Misoprostol, for example: Erythromycin, Aspirin, Misoprostol, Itraconazole, Mifepristone, Ketoconazole. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Femikit?
Femikit is a prescription (Rx) medicine. Take it as your doctor advises.