INFORMATION FOR PATIENTS
MTPill
Read this information carefully before taking MTPill (along with MISOPROST] It will help you understand how the treatment works. This Medication Guide is not a substitute for your doctor's advice
What is MTPill?
MTPill blocks a hormone needed for your pregnancy to continue. When used together with another medicine called MISOPROST (MISOPROSTOL) MTPill can end your pregnancy of 49 days.
How should I take MTPill?
• Day 1
Your doctor will discuss benefit and risk of using MTPill After getting a physical examination, if advised by your doctor take 3 tablets of MTPill
• Day 3
Your Doctor will check to see if you are still pregnant
If you are still pregnant, your doctor will advise to take 2 MISOPROST
tablets
If you get cramps, nausea, diarrhea, and other symptoms, inform your Doctor, four Doctor may send you home with medicines for these symptoms.
• On Day 14
This follow-up visit is very important. You must return to the Doctor about 2 weeks after you took MTPill to be sure you are well and that you are not pregnant
Your Doctor will check whether your pregnancy has completely ended. If it has not ended, there is a chance that there may be birth defects If you are still pregnant, your Doctor will talk with you about the other choices you have, including a surgical procedure to end your pregnancy
Who should not take MTPill?
Some women should not take MTPill. Do not take it if:
• It has been more than 49 day* (7 weeks) since your last menstrual period began
• You have an IUD (a contraceptive device put in the utereus). It must be taken betore you take MTPill
• Your doctor has told you that you have a pregnancy outside tho uterus (ectopic pregnancy)
• You have problems with your adrenal glands (chronic adrenal failure)
• You take a medicine to thin your blood
• You have a bleeding problem
• You take certain steroid medicines
• You cannot return for the next 2 visits.
• You cannot easily get emergency medical help in the 2 weeks after you take MTPill
• You are allergic to mifepristone or Misoprostol Tell your Doctor about all your medical condtions to find out if you can take MTPill. Also, tell your Doctor it you smoke at teast 10 cigarettes a day
What should I avoid while taking MTPill and Mlsoprost?
You should not take certain other medicines, because they may interfere with the treatment. Ask your Doctor ahout what medicines you can take for pain Do not take any other prescription or nonprescription medicines (including herbal medicines or supplements) at any time during the treatment period without first asking your doctor about them. If you are breast feeding at the time you are advised to take MTPill and Misoprost, discuss with your doctor if you should stop breast feeding for a few days
What are the possible side effects of using MTPill?
Symptoms to expect
This treatment causes cramping and bleeding. Usually, these symptoms mean
that the treatment is working. B sometimes you can get cramps ar bleeding and still be pregnant. This is why you must return to your doctor on Day 3 and on Day 14.
if you are not already. bleeding after taking MTPill, you probably will begin to bleed once you take Misoprost. This is the medicine you take on. Day 3. This is an expected part of ending the pregnancy. Bleeding or spotting can be expected for an average of 9-16 days and may last upto 30days. Your bleeding maybe similiar to. or greater than, a normal heavy period. You may see blood clots and tissue that come from your uterus.
Heavy bleeding and the need of surgery
in some cases, bleeding can be very heavy. In a very few cases, this bleeding will need to be stopped by a surgical procedure. Contact your Doctor right away if you bleeding enough to soak through two thick full-size sanitary pad for every for two consecutive hours or if you are concerned about heavy bleeding.
What has to be done if you are still pregnant after MTPill and Misoprost treatment?
It you are still prpgnant, your Doctor will talk with you about the other choices you have including a surgical procedure to end your pregnancy. There is a chance that the may be birth defects If the pregnancy is not ended.
When should I begin birth control?
You can become pregnant again right after your pregnancy ends. If you do not want become pregnant again, start using birth control method as soon as your pregnancy ends or before you start having sexual intercourse again.
For the use only of a registered medical practitioner or a hospital or a laboratory
Mifepristone Tablets 200 mg
Composition
Each uncoated tablet contains
Mifepristone............................. 200 mg
Description
MTPill contains mifepristone which has anti-progestational activity. The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Mifepristone also exhibits antiglucocorticoid and weak anti-androgenic activity.
Indication
MTPill is indicated for the medical termination of intrauterine pregnancy through 49 days pregnancy. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 days cycle with ovulation occurring at mid-cycle. The duration of pregnancy may be determined from menstrual history and by clinical examination. Ultrasonographic scan should be used it the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.
Any intrauterine device ["IUD"] should be removed before treatment with MTPill begins. Patients taking MTPIH must take 400 mcg of Misoprost two days after taking mifepristone unless a complete abortion has already been confirmed before that time (see
DOSAGEAND ADMINISTRATION). Pregnancy termination by surgery is recommended in cases when MTPill and Misoprost fail to cause termination of intrauterine pregnancy.
Dosage and Administration Treatment with Mifepristone (MTPill) requires concurent administration of misoprostol (Misoprost) Treatment with MTPill and Mlsoprost for the termination of pregnancy requires three office visits by
the patient. MTPill may be administered only in a clinic, medical office, or hospital, by or under the supervision of a gynecologist, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Gynecologist must also be able to provide surgical intervention 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 One: MTPill Administration
Three 200 mg tablets (600 mg) of MTPill are taken in a single oral dose.
Day Three: MISOPROST Administration
The patient returns to the healthcare provider two days after ingesting MTPill. Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200 meg tablets (400 mcg) of Misoprost orally.
During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms (see ADVERSE REACTIONS). 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 it she has questions following the administration of the Misoprost
.
Day 14: Post-Treatment Examination
Patients will return for a follow-up visit approximately 14 days after the administration of MTPill. 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 is recommended to manage medical abortion treatment failures (see PRECAUTIONS. Pregnancy).
Contraindications
Administration of MTPill and Misoprost for
the termination of pregnancy (the "treatment procedure") is contraindicated in patients
with any one of the following conditions:
• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy):
• IUD in place
• Chronic adrenal failure;
• Concurrent long-term corticosteroid therapy
• History of allergy to mifepristone. Misoprostol or other prostaglandin:
• Hemorrhagic disorders or concurrent anticoagulant therapy:
• Inherited porphyria
Because it is important to have access to appropriate medical care if an emergency develops, the treatment procedure is contraindicated if a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the admmtstenng physician.
Warnings and Precautions
1. Bleeding: Vaginal bleeding occurs in almost all patients during the treatment procedure In general the duration of bleeding and spotting increased as the duration of the pregnancy increased. Normally it lasts for an average of 9 to 16 days.
In some cases, excessive bleeding may require treatment by vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions.
2.Confirmation of Pregnancy Termination Patients should be scheduled for and return for a follow-up visit at approximately 14 days after administration of mifepristone to confirm that the pregnancy is completely terminated and to assess the degree of bleeding. Vaginal bleeding is not evidence of the termination of pregnancy. Termination can be confirmed by clinical examination or ultrasonographic scan Lack of bleeding following treatment, however, usually indicates failure. Medical abortion failures should be managed with surgical termination.
Precautions
General
MTPill is available only in single dose packaging. Administration must be under the supervision of a gynecologist (see Dosage and Administration). There are no data on the safety and efficacy of mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes metlitus. severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of mifepristone. Although there is no clinical evidence, the effectiveness of MTPIH may be lower if Misoprostol is administered more than two days after mifepristone administration
Information for Patients
Patients should be fully advised of the treatment procedure and its effects. Each patient must understand:
• The necessity of completing the treatment schedule, including a follow-up visit approximately 14 days after taking MTPill
• That vaginal bleeding and uterine cramping probably will occur;
• That prolonged or heavy vaginal bleed ing is not proof of a complete expulsion;
• That if the treatment fails, there is a risk of fetal malformation;
• That medical abortion treatment fail ures are managed by surgical termination; and
• The steps to take in an emergency situ ation. including precise instructions and a telephone number that she can call if she has any problems or con cerns
Another pregnancy can occur following termination of pregnancy and before resumption of normal menses. Contraception can be initiated as soon as the termination of the pregnancy has been confirmed, or before the woman resumes sexual intercourse
Laboratory Tests
Clinical examination is necessary to confirm
the complete termination of pregnancy af the treatment procedure. Changes in quantitative human Chonor Gonadotropin (hCG) levels will not decisive until at least 10 days after the administration of MTPill. A continuing pregnancy can be confirmed ultrasonographic scan The existence of debris in the uterus following the treatment procedure will not necessarily require surgery for its removal. Decreases in hemoglobin concentration hematocrit and red blood cell count occur in some women who bleed heavily. Clinically significant changes in serum enzyme (serum glutamic oxaloacetic transaminase (SGOT). serum glutan pyruvic transaminase (SGPT), alkaline phosphatase, gamma-glutamyltransferase (GT) activities were rarely reported.
Drug Interactions
Afthough specific drug or food interactic with mifepristone have not been studied, the basis of this drug's metabolism by CYP3A4, it is possible that ketoconazo itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone) Furthermore rifampm, dexamethasone. St Johns Worts and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may include mifepristone metabolism (lowering serum levels of mifepristone). Based on in vitro inhibition informatic coadministration of mifepristone may le to an increase in serum levels of drugs tf are CYP 3A4 substrates. Due to the slow elimination of mifepristone from the body such interaction may be observed for prolonged period after its administration Therefore, caution should be exercise when mifepristone is administered with drugs that are CYP 3A4 substrates and have narrow therapeutic range, including some agents used during general anesthesia
.
Carcinogenesi. Mutagenesis. Impairment ot Fertility
No long-term studies to evaluate the carcinogenic potential of mifepristone have been performed. Results from studies conducted in vitro and in animals have revealed no genotoxic potential for mifepristone.
In a neonatal exposure study in rats, the administration of a subcutaneous dose of mifepristone up to 100 mg/kg on the first day after birth had no adverse effect on future reproductive function in males or females
Pregnancy
Mifepnstone is indicated for the use in the termination of pregnancy (through 49 days' pregnancy) and has no other approved indication for use during pregnancy.
Teratogens Effects
Several reports in the literature indicate that prostaglandins, including Misoprostol, may have teratogenic effects in human beings. Skull defects, cranial nerve palsies, delayed growth and psychomotor development, facial malformation and limb defects have all been reported after exposure during the first trimester.
Nonteratogenic Effects The indication for use of MTPill in conjunction with Misoprostol is for the termination of pregnancy through 49 days' duration of pregnancy (as dated from the first day of the last menstrual period). These drugs together disrupt pregnancy by causing decidual necrosis, myometrial contractions and cervical softening, leading to the expulsion of the products of conception.
Nursing Mothers
It is not known whether mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk tor a few days following administration of the medications.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Adverse reactions
The treatment procedure is designed to induce the vaginal bleeding and uterine cramping necessary to produce an abortion. Nearly all of the women who
receive Mifepristone and Misoprostol will report adverse reactions, and many can be expected to report more than one such reaction. About 90% of patients report adverse reactions following administration of Misoprostol on day three of the treatment procedure Women typically experience abdominal pain, including uterine cramping. Other commonly reported side effects were nausea, vomiting and diarrhea. Pelvic pain, fainting, headache, dizziness and asthenia occurred rarely. Some adverse reactions reported during the four hours following administration of Misoprostol were judged by women as being more severe than others; the percentage of women who considered any particular adverse event as severe ranged from 2 to 35%. After the third day of the treatment procedure, the number of reports of adverse reactions declined progressively, so that by day 14, reports were rare except for reports of bleeding and spotting.
Overdosage
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 that recommended for termination pregnancy, if a patient ingest a massive overdose, she should be observed closely for signs, of adrenal failure.
The oral acute lethal dose of mifepristone in the mouse, rat and dog is greater than 1000 mg/kg (about 10 times the human dose recommended for termination of pregnancy).
Storage:
Store below 30'C
Presentation
MTPill tablets ......Blister Pack of 1 tablet
Cipla
