MTP Kit Overview
MTP Kit is a combination of 1 mifepristone pill and 4 misoprostol tablets. It is approved for the medical termination of an intrauterine pregnancy with a gestation of up to 63 days relying on the first day of the last menstruation.
Mifepristone (RU 486) is a synthetic steroid that has an anti-progestational effect by competing with progesterone at progesterone receptors. Misoprostol, on the other hand, is a synthetic prostaglandin E1. Misoprostol elicits smooth muscle contractions in the myometrium as well as uterine cervix relaxation at the standard doses. Misoprostol’s uterotonic characteristics should aid in cervical opening and removal of the product of conception.
Mifepristone 200 mg is taken orally, accompanied by misoprostol 800 mcg (4 tablets of 200 mcg) vaginally 1–3 days later. Following the administration of mifepristone, the person should come back for a follow-up visit 14 days later.
NB: The medication may only be used under the guidance of a service provider and in a healthcare center, as specified by the MTP Act of 2002 and the MTP Rules of 2003.
This Section is for Doctors Only
If you are a patient then please go down to the patient section by following the table of content.
Composition of MTP Kit
An MTP Kit contains 5 tablets;
- 1 Mifepristone tablet(200mg)
- 4 Misoprostol tablets(200mcg each)
The MTP Kit is therapeutically indicated for the medical termination of an intrauterine pregnancy of up to 63 days gestation based on the first day of the very last menstruation(period).
Method of Use – Administration
MTP Kit is indicated for the medical termination of an intrauterine pregnancy with a conception of up to 63 days. Pregnancy is dated from the first day of the last menstrual period in a presumed 28-day cycle, with ovulation occurring at mid-cycle.
Menstrual background and detailed clinical examination can be used to determine the length of a pregnancy. An ultrasonographic scan should always be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is assumed.
Before starting mifepristone and misoprostol treatment, any intrauterine device (IUD) should be expelled. When the MTP Kit fails to induce the termination of an intrauterine pregnancy, recommended for patients.
Mifepristone can be given by or under the constant monitoring of a Gynaecologist, who can determine an embryo’s gestational age and make a diagnosis of ectopic pregnancies. The Gynaecologist should also be able to even provide surgical intervention in cases of imperfect abortion or excessive bleeding, or have plans in place to provide such care through others and be able to guarantee the patient access to health services equipped to provide blood transfusions and resuscitation if required.
Mifepristone 200 mg is taken orally, preceded by misoprostol 800 mcg (4 tablets of 200 mcg) vaginally 1–3 days later. Misoprostol can be administered by a healthcare professional or by the woman herself. If the abortion does not occur 4 hours after misoprostol administration, the 2nd dose of misoprostol 400 mcg (2 tablets of 200 mcg) may be administered vaginally or orally (depending upon preference and amount of bleeding).
Following the administration of mifepristone, the person should come back for a follow-up visit 14 days later. This visit is critical for confirming, via clinical examination or ultrasonographic scan, that the pregnancy has been terminated completely.
Patients who are pregnant at the time of this visit are at risk of fetal malformation as a result of the treatment. To manage medical abortion treatment failures, surgical termination is advised.
The administration of mifepristone and misoprostol for pregnancy termination (the “course of treatment”) is not recommended in patients who have any of the following conditions:
- A clinical history of allergy or oversensitivity to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching, or other types of skin reactions)
- Extra-uterine / ectopic pregnancy confirmed or suspected, or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
- IUD is in place (the IUD might interfere with pregnancy termination)
- Adrenal fatigue is a chronic condition in which the adrenal (risk of acute renal insufficiency)
- Hemorrhagic disorders or anticoagulant therapy concurrently (risk of heavy bleeding)
- Porphyrias inherited (risk of worsening or of precipitation of attacks)
- Long-term corticosteroid therapy administered concurrently (risk of acute renal insufficiency)
- Asthma that is too severe to be controlled by medication
- A gynecological examination, ultrasound scan, or biological tests did not reveal a pregnancy.
- Pregnant after 63 days of amenorrhoea
Because it is critical to have access to appropriate medical care if an emergency arises, the treatment procedure is contraindicated if a patient does not have sufficient access to medical care designed to provide immediate care of incomplete abortion, blood transfusions, and emergency resuscitation from the first visit until discharged by the administering health care provider during the time frame from the first visit until released by the administering healthcare professional.
Mifepristone should also not be used by any patient who is unable to comprehend the effects of the treatment procedure or adhere to its regimen.
Absolute Contraindications and Precautions
Mifepristone is not advised in patients with:
- Kidney failure
- Failure of the liver
- Patient with malnutrition
Mifepristone must be administered under the guidance of a competent Gynaecologist.
It is assumed that the use of mifepristone necessitates the same precautions as those taken prior to and during surgical abortion to avoid rhesus immunization.
There is no information on the safety and efficacy of mifepristone in women who have serious health conditions such as cardiovascular, hypertensive, hepatic, respiratory, or renal disease; insulin-dependent diabetes mellitus; severe anaemia; or heavy smoking. Women over the age of 35 who consume 10 or even more cigarettes per day should be approached with caution because such patients were usually excluded from mifepristone clinical trials.
Even though there is no clinical evidence, mifepristone’s usefulness may be reduced if misoprostol is administrated more than two days after mifepristone.
Patients who have prosthetic heart valves or who have had one previous clinical condition of infective endocarditis should be given prophylactic antibiotics.
A qualified trained healthcare professional must conduct a physical on a woman who has undergone genital mutilation to rule out any anatomical obstacles to medical abortion.
Pregnancies happened during clinical trials between embryo expulsion (abortion) and the resumption of menstruation. To avoid exposing a subsequent pregnancy to mifepristone, it is advised that unprotected sexual intercourse be avoided until the first menstrual period appears after the abortion. Accurate contraception should begin as soon as the pregnancy is terminated or before the woman restarts sexual intercourse.
Read The Double Marker Test
Provide Necessary Information to the Patient
Patients should be sufficiently briefed about the treatment procedure and its consequences. Each patient must fully understand:
- the requirement to combine treatment with prostaglandin to be administrated at a subsequent visit 1 to 3 days after mifepristone administration
- the importance of following through on the treatment plan, including a follow-up visit 2 weeks after getting mifepristone to ensure complete expulsion
- that vaginal bleeding and uterine cramping are likely to occur
- that prolonged heavy blood loss is not evidence of an abortion
- that there is a danger of foetal deformity if the methods fail
- that surgical dismissal is used to manage medical abortion treatment failures
the steps to take in an urgent situation, including specific instructions and a phone number she can call if she has any queries or issues.
A clinical examination is required to confirm that the pregnancy has been completely terminated following the treatment procedure. Changes in quantitative human chorionic gonadotropin (hCG) concentrations will not be significant until at least 10 days after mifepristone administration. An ultrasound scan can confirm an ongoing pregnancy.
The presence of debris in the uterus supporting the treatment procedure does not always necessitate surgery to remove it.
Some people who bleed heavily experience decreases in hemoglobin levels, haematocrit, and red blood cell count. During the French clinical studies of mifepristone and misoprostol, 5.5 percent of subjects experienced haemoglobin lessens of more than 2 g/dL.
Clinically meaningful changes in serum enzymatic activity (serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, alkaline phosphatase, gamma-glutamyltransferase ) have been noted infrequently.
Dexamethasone administration is advised in patients with suspected acute adrenal failure. A dose of 400mg mifepristone is antagonized by 1mg dexamethasone.
Because of mifepristone’s anti-glucocorticoid properties, the effectiveness of long-term corticosteroid-based management, including inhaled corticosteroids in asthmatic patients, may be reduced during the 3 to 4 days following mifepristone administration. Therapy should be tweaked.
The anti-prostaglandin characteristics of nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, may theoretically reduce the method’s effectiveness. There is limited research that co-administration of NSAIDs on the day of misoprostol administration has no negative effects on the effects of mifepristone or misoprostol and does not decrease the clinical efficacy of medical abortion.
Even after intramuscular administration of a prostaglandin analog, rare but severe cardiovascular events have been noted. As a result, women with cardiovascular disease risk factors or with a history of cardiovascular disease should be treated with caution.
If any of the adverse effects listed below occur following a spontaneous, surgical, or medical abortion, including the use of mifepristone, sufferers must be surveilled and receive appropriate clinical treatment and intervention.
Almost all patients experience uterine/vaginal bleeding throughout a medical abortion. The patient should be informed if there is any continuous vaginal bleeding (an average of about 13 days after mifepristone intake, up to three weeks in some women). Heavy bleeding may necessitate surgical evacuation of the uterus in a few instances. Bleeding is not proof of terminating a pregnancy because it occurs in the majority of cases of failure.
Bleeding can happen immediately after taking misoprostol, or it can happen later:
- Expulsion happens within 4 hours of misoprostol administration in 60% of cases.
- Expulsion happens within 24 to 72 hours of misoprostol ingestion in the residual 40% of cases.
Continuous heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of an imperfect abortion, other consequences, or an undetected extra-uterine pregnancy, and prompt medical or surgical intervention may be taken into consideration to avoid hypovolemic shock. If patients experience prolonged heavy vaginal bleeding after a medical abortion, they should be advised to seek urgent medical care.
Women should assume vaginal bleeding or notice for 9 to 16 days on average. Women experience heavy bleeding lasting an average of two days. Up to 8% of all participants may experience some sort of bleeding for at least 30 days. Overall, the average length of bleeding and spotting is expected to increase with the length of the pregnancy.
As long as proper expulsion has still not been recorded/reported, the patient should be advised not to travel far off the prescribing center. She should be given specific instructions on who to communicate with and where to go if she has any complications, especially if she has very heavy vaginal bleeding.
If an ongoing pregnancy is discovered after the follow-up visit, the woman should be offered another strategy of termination.
Because heavy bleeding requiring haemostatic curettage occurs in 0 – 1.8 percent of cases during the medical method of pregnancy termination, patients with haemostatic disorders, hypocoagulability, or anaemia should be given specialized treatment. Depending on the type of haemostatic disorder and the level of anemia, the decision to use the medical or surgical procedure should be made in consultation with specialized doctors.
Expulsion may occur in rare instances prior to misoprostol administration (around 3 percent of the cases). This does not preclude a follow-up visit to ensure complete expulsion and uterine vacuity.
Excessive uterine/vaginal bleeding commonly necessitates the use of uterotonics, vasoconstrictor drugs, curettage, saline infusions, and/or blood transfusions.
A follow-up visit should be scheduled within 14 days of mifepristone administration to confirm, using the effective methodology (clinical examination, ultrasound scan, and beta-hCG measurement), that expulsion/abortion has been finished and vaginal bleeding has stopped or been significantly reduced. If there is persistent bleeding (even if it is light) after the control/follow-up visit, its absence should be checked within a few days. If an ongoing pregnancy is assumed, a second ultrasound scan may be needed to determine the viability of the pregnancy.
Infection and Sepsis
When the cervix dilates after abortion or childbirth, the genital tract is more vulnerable to ascending infection. There is little information on the occurrence of clinically meaningful pelvic infection following medical abortion, but it appears to be uncommon and likely occurs less frequently than after vacuum aspiration. Most of those symptoms of pelvic infection, like pain, are frequently nonspecific, making accurate diagnosis complicated. A sustained fever (> 4 hours) of 100.4°F or higher, severe pelvic/abdominal pain or pelvic/abdominal or adnexal tenderness in the days following a medical abortion may be an indication of infection, and medical support should be administered.
After medical abortion with 200mg mifepristone followed by non-authorized vaginal administration of misoprostol tablets for oral use, very rare cases of fatal or serious toxic shock caused by pathogens such as Clostridium sordellii endometritis, Escherichia coli presenting with or without fever or other obvious symptoms of infection have been reported. This infection cannot be ruled out when using vaginal misoprostol.
A Gynaecologist assessing a patient undergoing a medical abortion should be aware of the possibility of this uncommon but potentially fatal health problem.
If a patient described abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) and over 24 hours after taking misoprostol, a high index of suspicion is required to rule out sepsis (e.g., Clostridium sordellii). Deaths have been reported in patients who did not have a fever, abdominal pain, or tachycardia, but did have leucocytosis with a marked left shift, tachycardia, haemoconcentration, and general malaise. The majority of these deaths occurred in women who received misoprostol vaginally. There is no evidence of a link between mifepristone or misoprostol use and an increased risk of infection or death. Clostridium sordellii infections have also been reported in very rare cases after childbirth (via vaginal delivery and cesarean section), as well as in other gynecologic and non-gynecologic conditions.
Pregnancy Termination and Ectopic Pregnancy
Patients should be scheduled for and return for a follow-up visit 14 days after mifepristone administration to confirm that the pregnancy has been completely terminated and to assess the degree of bleeding. Clinical examination or an ultrasonographic scan can confirm termination. Lack of bleeding after treatment usually indicates failure; however, prolonged or heavy bleeding does not always indicate a complete abortion. Medical abortions that fail should be terminated surgically. Before prescribing mifepristone, inform the patient whether you will provide such care or refer her to another provider as part of the counseling process.
Mifepristone is not effective in terminating ectopic pregnancies, so it is not recommended for patients who have a confirmed or suspected ectopic pregnancy. Because some of the expected symptoms of medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy, gynecologists should be alert to the possibility that a patient undergoing a medical abortion may have an undiagnosed ectopic pregnancy. Even if the patient had ultrasonography before being prescribed mifepristone, the presence of an ectopic pregnancy could have been missed.
Women who become pregnant while wearing an IUD should be evaluated for ectopic pregnancy.
Other Possible Side Effects
Pregnancy-related symptoms such as nausea and vomiting may worsen after mifepristone, then worsen again after misoprostol administration, before weakening and disappearing during the abortion process. The most common symptoms are lower abdominal pain and cramping, which are associated with misoprostol administration and the abortion procedure. If pain persists after the expulsion of the products of conception, the source of the pain should be determined. Diarrhea is the most common dose-related side effect associated with misoprostol use, and it is usually self-limiting. Some women report chills, shivering, and/or a rise in temperature after taking misoprostol.
Pharmacological Overview of MTP Kit
Mifepristone antagonizes progesterone’s endometrial and myometrial effects in women at doses greater than 1 mg/kg. It sensitizes the myometrium to the contraction-inducing action of prostaglandins during pregnancy. Prostaglandin has the greatest effect when given 36 to 48 hours after mifepristone.
During the first trimester, pre-treatment with mifepristone causes softening and dilatation of the cervix, which is detectable as early as 24 hours after administration and reaches a peak 36 to 48 hours later. While clinical data show that mifepristone facilitates cervix dilatation, there is no evidence that it reduces the rate of early or late complications associated with the dilatation procedure.
In the event of early pregnancy termination, the use of a prostaglandin analog in a sequential regimen after mifepristone increases the success rate to about 95 percent of the cases and speeds up the expulsion of the conceptus.
The results of clinical trials vary slightly depending on the prostaglandin used and the time of application. Mifepristone in combination with prostaglandin analogs other than misoprostol and gemeprost has not been studied.
The glucocorticoid receptor is bound by mifepristone. It inhibits the action of dexamethasone in animals at doses ranging from 10 to 25 mg/kg. At doses greater than 4.5 mg/kg, the anti-glucocorticoid action is manifested in humans by a compensatory increase in adrenocorticotropic hormone (ACTH) and cortisol. Following a single administration of 200 mg mifepristone for pregnancy termination, glucocorticoid bioactivity may be reduced for several days. The clinical implications are unknown; however, in susceptible women, vomiting and nausea may be increased.
Mifepristone has a weak anti-androgenic effect in animals that appears only after prolonged administration of extremely high doses.
When administered vaginally, the increase in uterine tonus begins around 20 minutes and peaks at 46 minutes. After vaginal administration, uterine contractility increases continuously for 4 hours. Misoprostol administered vaginally produces far more powerful and consistent contractions than misoprostol administered orally.
In the event of early pregnancy termination, the combination of a prostaglandin analog used in a sequential regimen after mifepristone causes the conceptus to be expelled. When 200 mg mifepristone is combined with misoprostol 800 mcg for up to 63 days of amenorrhoea, the success rate is around 95% in clinical trials.
MTP Kit Overdose
Tolerance studies in healthy non-pregnant female and healthy male subjects where mifepristone was administered in single doses greater than 1800 mg revealed no serious adverse reactions (nine-fold the recommended dose for termination of pregnancy). In the event of unintentional massive ingestion, she should be closely monitored because signs of adrenal failure may occur. Acute intoxication symptoms may necessitate specialized treatment, such as the administration of dexamethasone.
Misoprostol’s toxic dose in humans has not been determined. Cumulative total daily doses of 1600 mcg were tolerated with only gastrointestinal discomfort reported. Sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension, or bradycardia are clinical signs of an overdose. Supportive therapy should be used to treat symptoms. It is unknown whether misoprostol acid can be dialyzed. However, because misoprostol is metabolized like a fatty acid, dialysis is unlikely to be an effective treatment for overdosage. In the event of an overdose, standard supportive measures should be implemented as needed.
What is MTP Kit?
MTP Kit is a combination therapy that includes the medications mifepristone and misoprostol. The MTP Kit is intended for the medical termination of an intrauterine pregnancy of up to 63 days gestation based on the first day of your last menstrual period.
Mifepristone is an anti-hormone that works by inhibiting the effects of progesterone, a hormone required for pregnancy to continue. Misoprostol is a prostaglandin, which is a substance that causes the womb to contract, allowing the pregnancy to be expelled. As a result, the two drugs can cause pregnancy termination and must be taken one after the other to give the treatment the best chance of success.
Important Points to Know Before Using It
Do not take mifepristone or misoprostol tablets if you have the following conditions.
- Your pregnancy has not been confirmed by a gynecological exam, ultrasound scan, or biological tests.
- Your most recent period began more than 63 days ago (if there is any doubt, the doctor can check the age of your pregnancy with a scanner),
- Your doctor believes that you are pregnant outside of your womb (the egg is implanted outside the womb),
- If you have a blood clotting disorder or are taking blood thinners,
- you’ve had genital cutting or circumcision,
- You are not permitted to return for a follow-up visit to ensure that the pregnancy has been completely terminated.
- You won’t be able to get emergency medical help for two weeks after taking mifepristone and misoprostol.
- If you are allergic to mifepristone, misoprostol (or any other prostaglandin), or any of the other ingredients in this medication, consult your doctor.
- You have severe asthma that is not adequately treated with medication.
- You have hereditary porphyria (an inherited blood disorder), and you have chronic adrenal failure.
- You are the owner of an intrauterine device (this must be removed prior to administering mifepristone tablet)
Consult with your doctor if you have the following conditions;
- Heart problems or conditions
- Previous heart surgery
- High blood pressure, high level of cholesterol
- Bleeding disorder or clotting disorder
- Liver and kidney disease or conditions
Inform your doctor if you are currently taking, have recently taken, or plan to take any other medications. Medicines containing the following active ingredients, in particular, may interfere with the action of mifepristone and misoprostol.
- Ketoconazole, itraconazole
- Erythromycin, rifampicin
- St john’s wort
- Phenytoin, phenobarbital, carbamazepine
Pregnancy and Breastfeeding
Mifepristone and misoprostol may pass into breast milk and be consumed by your child. After completing the treatment, you should discontinue breastfeeding. There is little information available about the risks to an unborn baby. If the pregnancy continues and you decide to keep it, talk to your doctor, who will set up careful prenatal monitoring and ultrasounds. After taking mifepristone and misoprostol, it is advised that you avoid becoming pregnant again before your next menstrual period.
How to Use the MTP Kit?
Pregnancies that have occurred with an intrauterine contraceptive device (coil) in place must be removed before mifepristone and misoprostol are administered.
It is advised that you do not travel too far from the prescribing hospital/clinic until the scheduled follow-up visit. In the event of an emergency or if you are concerned for any reason, you may contact or return to the hospital/clinic before your scheduled appointment time. You will be given a phone number to call in case of an emergency or if you have any problems.
Visits and Follow-Ups
You need to visit the hospital minimum of 3 times. Let’s know about that.
In the presence of a doctor, you will be given one mifepristone 200 mg tablet to swallow with some water.
You will be able to go home after taking the mifepristone tablet if the doctor determines that you will not become ill. Please notify your doctor if you experience symptoms such as severe abdominal pain, fainting, rapid heartbeat, or fever lasting more than 4 hours after taking the tablet.
In rare cases, the pregnancy may be terminated before the misoprostol tablets are taken. It is important that you return to the hospital/clinic to confirm that the pregnancy has been terminated completely.
2nd or Follow Up Visit
As directed by your doctor, you must return to the hospital/clinic 1-3 days after taking mifepristone.
To ensure that the treatment is effective, you will be given four misoprostol vaginal tablets. The tablets will be inserted into your vagina, or you can do it yourself. Please empty your bladder and thoroughly clean your hands before inserting the misoprostol vaginal tablets in this case. Push the four vaginal tablets up into the vagina as far as your finger will allow. After inserting the misoprostol vaginal tablets, it is recommended that you lie down for about 30 minutes.
You should stay in the hospital/clinic for a few hours, or until both you and the doctor are satisfied that you are well enough to go home. After misoprostol treatment, the pregnancy may be expelled within a few hours or over the next few days.
Within 14 days of taking the mifepristone tablet, you should therefore return to the hospital/clinic for a consult.
It is important that you keep this appointment to ensure that your pregnancy has been completely removed and that you are healthy, as you will not be able to judge whether or not the treatment was successful.
Overdose and Missed Dose
Because you will be supervised during treatment administration, it is unlikely that you will take more than you should.
If you fail to take any part of the treatment, it may not be as effective as it should be. If you forget to take your medication, consult your doctor.
If you have any further questions about how to use this medication, consult your doctor.
Side Effects and Other Facts
Please follow the table of content and read the side effects mentioned above.
MTP Kit Summery
Before using MTP Kit, carefully read the following information. This information will help to answer some of the most frequently asked questions about medical abortion. It is not intended to replace medical advice.
MTP Kit should only be used to end a pregnancy after 63 days (9 weeks).
MTP Kit is not recommended for terminating later pregnancies (those lasting more than 63 days).