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MTP Kit is indicated for use in the termination of pregnancy (through 63 days pregnancy) and has no other approved indication for use during pregnancy. In humans, the few reported cases of malformations do not allow a causality assessment for mifepristone alone or associated to prostaglandin. Therefore, data is too limited to determine whether the molecule is a human teratogen. There is currently no relevant clinical data that suggest the possible occurrence of malformation after the ******* use of misoprostol during pregnancy. However, in a few cases where misoprostol was self -administered (orally or vaginally) in order to induce an abortion, the following deleterious effects of misoprostol have been suggested: malformations of limbs, of foetus movements and of cranial nerves (hypomimia, abnormalities in suckling, deglutition, and eye movements). To date, a risk of malformation cannot be excluded.abortion pills for sale in Bahrain, Mifeprex available in Bahrain, Abortion-rights movements, also referred to as pro-choice movements, advocate for legal access to induced abortion services including elective abortion. It is the argument against the anti-abortion movement. The abortion rights movement seeks out to represent and support women who wish to terminate their pregnancy at any point. This moveMTP Kit contains 1 tablet of mifepristone 200 mg to be given orally and 4 tablets of 200 mcg misoprostol to be given vaginally for the medical termination of pregnancy up to 63 days (9 weeks). This kit has been developed in accordance with guidelines issued by the Royal College of Obstetricians and Gynaecologists, UK.Our Women’s Health Center located in Abu Dhabi, United Arab Emirates, uses the latest medications for medical abortions
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Pills by Post – Abortion Pill treatment at home

For women from England and Wales

(and NI in certain circumstances)

If you are from Scotland and want to access Pills by Post please call us for more information.



Medical abortion: The abortion pill by post

This service is a safe and legal way to end a pregnancy at an early gestation without needing to attend a clinic for treatment. You should contact BPAS on our bookings and information line 03457 30 40 30 (or if you are from Northern Ireland call 0300 500 8086) to book a telephone consultation and full medical assessment with a trained nurse or midwife who will assess your suitability for treatment. Most women are eligible for NHS-funded treatment and we can discuss whether this applies to you when you call. If treatment is suitable and safe, you will receive abortion pills by post a few days later, or we can book you for an alternative treatment in the clinic.

Medical assessment

You will have your consultation and medical assessment over the telephone and have opted for remote abortion pill treatment (pills by post).

Consent

We will explain the known risks and complications of your treatment during your telephone assessment. The risks and complications of this treatment are shown below.

Risks and complications of the abortion pill

Significant unavoidable or frequently occurring risks

These are usually easy to treat and rarely have any long-term health effects:

You may see a recognizable pregnancy
Unpredictable time to complete the procedure (variable)
Side effects of drugs such as nausea, vomiting, diarrhea, headache, dizziness, fever/chills (common)
Retained products of conception - where the pregnancy is no longer growing but some of the pregnancy tissue is left behind in the womb (2 in 100)
Infection (2 in 1,000)
Unpredictable, irregular, or prolonged bleeding after the abortion (variable)
Pain during the procedure (common)
Pregnancy being significantly later than realized (less than 1 in 1,000). Rarely if a much later pregnancy was not suspected, this may mean the abortion fails, there is more pain or bleeding, or in extreme circumstances a live birth
These may require transfer to hospital or surgical procedures, and may have serious long-term health effects:

Continuing pregnancy (less than 1 in 100)
Hemorrhage – very heavy bleeding (2 in 1,000)
Undiagnosed ectopic pregnancy (1 in 7,000)
Psychological problems (variable)
Extra procedures that may be necessary

Surgical abortion or uterine aspiration (3 in 100)
Blood transfusion
Laparoscopy or laparotomy – operation to look inside the abdomen
Hysterectomy – surgical removal of the womb (2 in 100,000)
Death is very rarely linked to abortion treatment (less than 1 in 100,000 for all abortions).

Treatment

You will receive your treatment package direct from the pharmacy from 1 to 3 days from your telephone consultation (sometimes longer with Bank Holidays). If your package is delayed in the post for a few days you should still take the tablets as directed once they arrive. The package is plain with no indication of its contents, it will be tracked but not signed for. Your pack will contain:

Mabon pack containing 1 tablet of mifepristone (step 1) and 4 tablets of misoprostol (step 2)
2 plastic-wrapped misoprostol tablets (step 3)
Pregnancy test (step 4)
Codeine (only provided if medically suitable)
Your chosen contraceptive pills, patches, or rings (if requested and suitable) - you will need to supply your height, weight, and blood pressure reading for patches, pills, and combined hormonal pills. Click for details where to get blood pressure readings
STI test - you may also receive a chlamydia and gonorrhea test. Blood affects the results of this test, so it is best to complete this before starting your treatment. Click for details.
This medication is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it. This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion).

How to use Cytotec

This medicine comes with a patient information leaflet. Read it carefully. If you have any questions about this drug, ask your doctor, nurse, or pharmacist.

Dosage is based on your medical condition and response to therapy.

If you are taking this drug to prevent stomach ulcers, take it by mouth usually four times a day, after meals and at bedtime to minimize diarrhea, or as directed by your doctor.

If you are taking this medication for abortion, take it by mouth exactly as directed by your doctor.

If you are using this medication to start labor, your healthcare professional will insert it into your ******.

Avoid taking antacids that contain magnesium while using misoprostol because they may make diarrhea it causes worse. If you need an antacid, consult your doctor or pharmacist to help you choose a product.

For ulcer prevention, continue to take this drug for as long as you take NSAIDs. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Inform your doctor if your condition persists or worsens.

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Related Links

List Cytotec side effects by likelihood and severity
Who should not take Cytotec?
What should I know regarding pregnancy, nursing, and administering Cytotec to children or the elderly?
What conditions does Cytotec treat?


What is Cytotec?

Cytotec reduces stomach acid and helps protect the stomach from damage that can be caused by taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Cytotec is used to prevent stomach ulcers during treatment with aspirin or an NSAID.

Cytotec may also be used for purposes not listed in this medication guide.

Warnings

Cytotec can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage, and dangerous uterine bleeding. Do not use this medicine if you are pregnant.

If you are able to become pregnant, you will need to have a negative pregnancy test before starting this treatment. You will also need to use effective birth control to prevent pregnancy during treatment.

Before taking this medicine

You should not use Cytotec if you are allergic to Cytotec or other prostaglandins, or if you are pregnant.

To make sure Cytotec is safe for you, tell your doctor if you have:

inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other intestinal problems;
heart disease; or
if you are dehydrated.
FDA pregnancy category X. Cytotec can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage, and dangerous uterine bleeding. Do not use this medicine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 1 month after your treatment ends.

If you are able to become pregnant, you will need to have a negative pregnancy test before you start taking Cytotec. Treatment with this medicine should begin on the second or third day of your menstrual period.



Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

It is not known whether misoprostol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

How should I take Cytotec?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not share this medicine with another person.

Cytotec is usually taken with meals and at bedtime. Follow your doctor's instructions.

You may have nausea, stomach cramps, or diarrhea while taking this medicine, especially during the first few weeks after you start taking Cytotec. These symptoms usually last for about a week.

Call your doctor if you have severe nausea, stomach pain, or diarrhea lasting longer than 8 days.

Read all medication guides or patient instructions provided with this medicine each time you receive a new supply.

Store at room temperature away from moisture and heat.

Detailed Cytotec dosage information

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

MTP Kit (Mifepristone + Misoprostol)

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Prescribing Information
Overview
Related Resources
For the use of Gynaecologists only

Warning

Product is to be used only under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 and MTP Rules 2003.

Qualitative and Quantitative Composition

Each pack contains 5 tablets:
A. 1 Mifepristone Tablet

Each uncoated tablet contains:

Mifepristone…200 mg

B. 4 Misoprostol Tablets

Each uncoated tablet contains:

Misoprostol…200 mcg

Dosage Form and Strength

Mifepristone tablet for oral use and misoprostol tablets for ******* use.

Clinical Particulars

Therapeutic Indication

MTP Kit is indicated for the medical termination of intrauterine pregnancy of up to 63 days gestation based on the first day of the last menstrual period.

Posology and Method of Administration

MTP Kit is indicated for the medical termination of intrauterine pregnancy of up to 63 days of gestation. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28-day 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 if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.

Any intrauterine device (IUD) should be removed before treatment with mifepristone and misoprostol begins. Pregnancy termination by surgery is recommended in cases when MTP Kit fails to cause termination of intrauterine pregnancy.

Mifepristone may be administered by or under the supervision of a Gynaecologist, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The Gynaecologist 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 the patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

The dosage is mifepristone 200 mg orally followed 1 – 3 days later by misoprostol 800 mcg (4 tablets of 200 mcg) vaginally. The misoprostol may be administered by a health care provider or self-administered by the woman. For women at 49 – 63 days of gestation, if abortion has not occurred 4 hours after administration of misoprostol, a second dose of misoprostol 400 mcg (2 tablets of 200 mcg) may be administered vaginally or orally (depending upon preference and amount of bleeding).

The patient should return for a follow-up visit approximately 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 foetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

Contraindications

Administration of mifepristone and misoprostol for the termination of pregnancy (the ‘treatment procedure’) is contraindicated in patients with any one of the following conditions:

History of allergy or known hypersensitivity to mifepristone, misoprostol or other prostaglandin (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
Confirmed or suspected extra-uterine / ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
IUD in place (the IUD might interfere with pregnancy termination)
Chronic adrenal failure (risk of acute renal insufficiency)
Haemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
Inherited porphyrias (risk of worsening or of precipitation of attacks)
Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
Severe asthma uncontrolled by therapy
Pregnancy not confirmed by gynaecological examination, ultrasound scan or biological tests
Pregnancy beyond 63 days of amenorrhoea
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 administering health care provider.

Mifepristone also should not be used by any patient who may be unable to understand the effects of the treatment procedure or to comply with its regimen.

Special Warnings and Precautions for Use

General

In the absence of specific studies, mifepristone is not recommended in patients with:

Renal failure
Hepatic failure
Malnutrition
The administration of mifepristone must be under the supervision of a qualified Gynaecologist.

The use of mifepristone is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

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 mellitus; severe anaemia 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 mifepristone may be lower if misoprostol is administered more than 2 days after mifepristone administration.

Patients with prosthetic heart valves or who have had one previous episode of infective endocarditis should receive appropriate prophylactic antibiotic treatment.

A physical examination must be performed by a qualified trained medical professional in a woman who has undergone genital mutilation to exclude any anatomical obstacles to medical abortion.

During clinical trials, pregnancies occurred between embryo expulsion (abortion) and the resumption of menses. To avoid potential exposure of a subsequent pregnancy to mifepristone, it is recommended that unprotected sexual intercourse be avoided until the appearance of the first menses after the abortion. Reliable contraception should commence as soon as the termination of the pregnancy has been confirmed, or before the woman resumes sexual intercourse.

Information for Patients

Patients should be fully advised of the treatment procedure and its effects. Each patient must understand:

the necessity to combine treatment with prostaglandin to be administered at a second visit, 1 to 3 days after administration of mifepristone
the necessity of completing the treatment schedule, including a follow-up visit approximately 14 days after taking mifepristone in order to check for complete expulsion
that ******* bleeding and uterine cramping probably will occur
that prolonged heavy ******* bleeding is not proof of a complete abortion
that if the treatment fails, there is a risk of foetal malformation
that medical abortion treatment failures are managed by surgical termination
the steps to take in an emergency situation, including precise instructions and a telephone number that she can call if she has any problems or concerns
Laboratory Tests

Clinical examination is necessary to confirm the complete termination of pregnancy after the treatment procedure. Changes in quantitative human chorionic gonadotropin (hCG) levels will not be decisive until at least 10 days after the administration of mifepristone. A continuing pregnancy can be confirmed by ultrasonographic scan.

The existence of debris in the uterus following the treatment procedure will not necessarily require surgery for its removal.

Decreases in haemoglobin concentration, haematocrit and red blood cell count occur in some women who bleed heavily. Haemoglobin decreases of more than 2 g/dL occurred in 5.5% of subjects during the French clinical trials of mifepristone and misoprostol.

Clinically significant changes in serum enzyme (serum glutamic oxaloacetic transaminase , serum glutamic pyruvic transaminase , alkaline phosphatase, gamma-glutamyltransferase ) activities were rarely reported.

Precautions for Use

In case of suspected acute adrenal failure, dexamethasone administration is recommended. 1mg of dexamethasone antagonizes a dose of 400mg of mifepristone.

Due to the anti-glucocorticoid activity of mifepristone, the efficacy of long-term corticosteroid therapy, including inhaled corticosteroids in asthmatic patients, may be decreased during the 3 to 4 days following intake of mifepristone. Therapy should be adjusted.

A decrease of the efficacy of the method can theoretically occur due to the anti-prostaglandin properties of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin (acetyl salicylic acid). Limited evidence suggests that co-administration of NSAIDs on the day of misoprostol administration does not adversely influence the effects of mifepristone or misoprostol and does not reduce the clinical efficacy of medical termination of pregnancy.

Rare but serious cardiovascular accidents have been reported following the intramuscular administration of prostaglandin analogue. For this reason, women with risk factors for cardiovascular disease or established cardiovascular disease should be treated with caution.

Serious Adverse Events

Patients must be monitored and undergo appropriate medical evaluation and intervention should any of the serious adverse events mentioned below occur following a spontaneous, surgical or medical abortion, including following mifepristone use:

Uterine / ******* Bleeding

Uterine / ******* bleeding occurs in almost all patients during a medical abortion. The patient must be informed of the occurrence of prolonged ******* bleeding (an average of about 13 days after mifepristone intake, up to three weeks in some women). In a few cases, heavy bleeding may require surgical evacuation of the uterus. Bleeding is not in any way a proof of termination of pregnancy as it occurs also in most cases of failure.

The bleeding can occur very quickly after misoprostol intake, and sometimes later:

In 60%, expulsion occurs within 4 hours following misoprostol intake
In the remaining 40% of the cases, expulsion occurs within 24 to 72 hours following misoprostol intake.
Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for 2 consecutive hours) may be a sign of incomplete abortion or other complications or an unnoticed extra-uterine pregnancy, and prompt medical or surgical intervention may be considered to prevent the development of hypovolemic shock. Patients should be counseled to seek immediate medical attention if they experience prolonged heavy ******* bleeding following a medical abortion.

Women should expect to experience ******* bleeding or spotting for an average of 9 - 16 days. Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.

The patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been recorded / confirmed. She should be given precise instructions as to whom she should contact and where to go in the event of any problems, particularly in the case of very heavy ******* bleeding.

In the event of an ongoing pregnancy diagnosed after the follow-up visit, termination by another method should be proposed to the woman.

Since heavy bleeding requiring haemostatic curettage occurs in 0 - 1.8% of the cases during the medical method of pregnancy termination, special care should be given to patients with haemostatic disorders, with hypocoagulability, or with anaemia. The decision to use the medical or the surgical method should be decided with specialized consultants according to the type of haemostatic disorder and the level of anaemia.

Rarely the expulsion may occur before misoprostol administration (around 3% of the cases). This does not preclude the control visit in order to check for the complete expulsion and the uterine vacuity.

Excessive uterine / ******* bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions.

A follow-up visit must take place within a period of approximately 14 days after administration of mifepristone to verify by the appropriate means (clinical examination, ultrasound scan, and beta-hCG measurement) that expulsion / abortion has been completed and that ******* bleeding has stopped or substantially reduced. In case of persistent bleeding (even light) beyond the control / follow-up visit, its disappearance should be checked within a few days. If an ongoing pregnancy is suspected, a further ultrasound scan may be required to evaluate its viability.

Infection and Sepsis

The genital tract is more susceptible to ascending infection when the cervix is dilated after abortion or childbirth. There are few data on the incidence of clinically significant pelvic infection after medical abortion, but it seems to be rare and probably occurs less often than after vacuum aspiration. Many of the symptoms of pelvic infection, such as pain, are often nonspecific and hence precise diagnosis is difficult. In particular, a sustained fever (> 4 hours) of 100.4°F or higher, severe pelvic / abdominal pain, pelvic / abdominal or adnexal tenderness in the days after a medical abortion may be an indication of infection and appropriate treatment should be given.

Very rare cases of fatal or serious toxic shock caused by pathogens like Clostridium sordellii endometritis, Escherichia coli presenting with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200mg mifepristone followed by non-authorized ******* administration of misoprostol tablets for oral use. It cannot be excluded that this infection may occur also with ******* misoprostol.

The Gynaecologist evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare, but potentially fatal complication.

A high index of suspicion is needed to rule out sepsis (e.g. Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhoea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leucocytosis with a marked left shift, tachycardia, haemoconcentration, and general malaise. Most of these deaths occurred in women who used vaginally administered misoprostol. No causal relationship between mifepristone, misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (******* delivery and caesarean section), and in other gynaecologic and non-gynaecologic conditions.

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. Termination can be confirmed by clinical examination or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion. Medical abortion failures should be managed with surgical termination. Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing mifepristone.

Ectopic Pregnancy

Mifepristone is contraindicated in patients with a confirmed or suspected ectopic pregnancy since mifepristone is not effective for terminating these pregnancies. Gynaecologists should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy since some of the expected symptoms of a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed mifepristone.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Other risks

Pregnancy related symptoms such as nausea and vomiting may increase after mifepristone and increase further after misoprostol administration, and they will weaken and disappear during the abortion process. Lower abdominal pain and cramping are the most common symptoms and they are related to misoprostol administration and the abortion process. If pain persists after expulsion of the products of conception, its origin should be investigated. Diarrhoea is the most common dose related side effect related to misoprostol use which normally does not require treatment. Some women also report chills, shivering and/or temperature rise after misoprostol administration.

Any reproductive tract infections should be treated before the medical abortion regimen is administered.

Misoprostol

The patient should not give misoprostol to anyone else.

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.
Some authors suggest moistening misoprostol with 3 - 4 drops of saline / distilled water when used for ******* administration.
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.
Drug Interactions

Mifepristone

Although specific drug or food interactions with mifepristone have not been studied, on the basis of this drug’s metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampin, dexamethasone, St. John’s Wort, and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of mifepristone). Whether this action has an impact on the efficacy of the dose regimen is unknown.

Based on in vitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates. Due to the slow elimination of mifepristone from the body, such interaction may be observed for a prolonged period after its administration. Therefore, caution should be exercised when mifepristone is administered with drugs that are CYP3A4 substrates and have narrow therapeutic range, including some agents used during general anaesthesia.

Misoprostol

Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin.

Misoprostol is predominantly metabolized via fatty acid oxidizing systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. In specific studies, no clinically significant pharmacokinetic interaction has been demonstrated with antipyrine or diazepam. A modest increase in propranolol concentrations (mean approximately 20% in AUC, 30% in Cmax) has been observed with multiple dosing of misoprostol. In extensive clinical studies no drug interactions have been attributed to misoprostol. Drug interaction studies with misoprostol and several NSAIDs showed no clinically significant effect on the kinetics of ibuprofen, diclofenac, piroxicam, aspirin, naproxen or indomethacin. Concomitant administration of NSAIDs and misoprostol in rare cases can cause a transaminase increase and peripheral oedema.

Magnesium-containing antacids should be avoided during treatment with misoprostol as this may worsen the misoprostol-induced diarrhoea.

Use in Special Populations

Patients with Renal Impairment

Mifepristone

The effects of renal disease on the safety, efficacy and pharmacokinetics of mifepristone have not been investigated. Mifepristone is not recommended in patients with renal impairment.

Misoprostol

No routine dosage adjustment is recommended in patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.

Patients with Hepatic Impairment

Mifepristone

The effects of hepatic disease on the safety, efficacy and pharmacokinetics of mifepristone have not been investigated. Mifepristone is not recommended in patients with hepatic impairment.

Misoprostol

Misoprostol is metabolized by fatty acid oxidizing systems present in organs throughout the body. Its metabolism and plasma levels are therefore unlikely to be affected markedly in patients with hepatic impairment.

Pregnant Women



Consequently,

Women should be informed that due to the non-negligible risk of failure of the medical method of pregnancy termination (which occurs in 4.5 to 7.8% of the cases) and to the unknown risk to the foetus, the post-treatment follow-up visit is mandatory;
Should a failure of the method be diagnosed at the post-treatment visit (viable ongoing pregnancy), and should the patient still agree, pregnancy termination should be completed by another method.
Should the patient wish to continue with her pregnancy, the available data are too limited to justify a systematic termination of an exposed pregnancy. In that event, a careful ultrasonographic monitoring of the pregnancy should be carried out in a specialised centre, with a special attention to the limbs.
Teratogenic Effects

The risk of adverse developmental outcomes with a continued pregnancy after a failed pregnancy termination with mifepristone tablets, 200 mg in a regimen with misoprostol is unknown; however, the process of a failed pregnancy termination could disrupt normal embryo-fetal development and result in adverse developmental effects. Birth defects have been reported with a continued pregnancy after a failed pregnancy termination with Mifepristone tablets, 200 mg in a regimen with misoprostol. In animal reproduction studies, increased fetal losses were observed in mice, rats, and rabbits and skull deformities were observed in rabbits with administration of mifepristone at doses lower than the human exposure level based on body surface area.

Cases of ongoing pregnancies not terminated by surgical abortion at the end of treatment with mifepristone alone have reported of sirenomelia and cleft palate.

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.

In teratology studies in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than 1/100 to approximately 1/3 the human exposure based on body surface area), because of the anti-progestational activity of mifepristone, fetal losses were much higher than in control animals. Skull deformities were detected in rabbit studies at approximately 1/6 the human exposure, although no teratogenic effects of mifepristone have been observed to date in rats or mice. These deformities were most likely due to the mechanical effects of uterine contractions resulting from inhibition of progesterone action. Animal studies have not evidenced teratogenicity of misoprostol but have shown its foetotoxicity at high doses.

Non-teratogenic Effects

The indication for use of MTP Kit is for the termination of pregnancy through 63 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.

Lactating Women

Mifepristone

Mifepristone is a lipophilic compound and may theoretically be excreted in the mother's breast milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. However, no data is available. Consequently, mifepristone and misoprostol use should be avoided during breastfeeding. Since the effects of mifepristone on infants are unknown, breastfeeding women should consult with their Gynaecologist to decide if they should discard their breast milk for a few days following administration of the medications.

Misoprostol

Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breastfeeding infants of mothers taking misoprostol. Misoprostol should not be administered to nursing mothers because the excretion of misoprostol acid could cause undesirable effects such as diarrhoea in nursing infants.

The developmental and health benefits of breastfeeding should be considered along with any potential adverse effects on the breastfed child from mifepristone in a regimen with misoprostol.

Paediatric Patients

Safety and effectiveness of mifepristone and misoprostol in paediatric patients have not been established.

Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

Mifepristone and misoprostol may cause dizziness, which could have an effect on the ability to drive and use machines.

Undesirable Effects

Mifepristone

The treatment procedure is designed to induce the ******* 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 3 of the treatment procedure. Women typically experience abdominal pain, including uterine cramping. ******* bleeding and uterine cramping are expected consequences of the action of mifepristone as used in the treatment procedure. Following administration of mifepristone and misoprostol,80 to 90% of women reported bleeding more heavily than they do during a heavy menstrual period Other commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness and asthenia occurred rarely. Some adverse reactions reported during the 4 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 - 35%. After the third day of the treatment procedure, the number of reports of adverse reactions declined progressively, so by day 14, reports were rare except for reports of bleeding and spotting.

Nervous System Disorders

Rare: Headache, insomnia, anxiety, syncope.

Gastrointestinal Disorders

Very common: Nausea, vomiting, diarrhoea (these gastrointestinal effects related to prostaglandin use are frequently reported), dyspepsia.

Common: Cramping, light or moderate.

Skin and Subcutaneous Tissue Disorders

Uncommon: Hypersensitivity, skin rashes (0.2%).

Rare: Single cases of urticaria, erythroderma, erythema nodosum, toxic epidermal necrolysis have also been reported.

Very rare: Angioedema

Infections and Infestations

Common: Infection following abortion. Suspected or confirmed infections (endometritis, pelvic inflammatory disease, salpingitis) have been reported in less than 5% of women.

Rare: Viral infection, vaginitis, sinusitis.

Very rare: Very rare cases of fatal toxic and septic shock (caused by Clostridium sordellii or Escherichia coli), presenting with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200 mg mifepristone followed by non-authorized ******* administration of misoprostol tablets for oral use. The health care providers should be aware of this potentially fatal complication.

Vascular Disorders

Uncommon to Rare: Hypotension (0.25%)

General Disorders and Administration Site Conditions

Rare: Malaise, fatigue, vagal symptoms (hot flushes, dizziness), rigors (chills, shaking), fever, back pain, asthenia, leg pain, anaemia, fainting, decrease in hemoglobin greater than 2 g/dL.

Reproductive System and Breast Disorders

Very common: Uterine contractions or cramping (10 to up to 80%) in the hours following prostaglandin intake.

Common: Uterine haemorrhage, heavy bleeding occurs in about 5% of the cases and may require haemostatic curettage in up to 1.8% of the cases.

Rare: During induction of second trimester termination of pregnancy or labour induction for foetal death in utero during the third trimester, uterine rupture has been uncommonly reported after prostaglandin intake. The reports occurred particularly in multiparous women or in women with a caesarean section scar. Leucorrhoea and pelvic pain have also been reported.

Misoprostol

General

Gastrointestinal side effects like diarrhoea (usually dose related and self-limiting), abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation
Shivering
Hyperthermia
Dizziness
Obstetrics and Gynaecological Use

Patient may experience pain due to uterine contractions
Severe genital bleeding
Shock
Pelvic pain
Uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy)
Women who received misoprostol during clinical trials reported the following gynaecological disorders: Spotting (0.7%), cramps (0.6%), hypermenorrhoea (0.5%), menstrual disorder (0.3%) and dysmenorrhoea (0.1%). Postmenopausal ******* bleeding may be related to misoprostol administration. If it occurs, diagnostic workup should be undertaken to rule out gynaecological pathology.

Incidence > 1%

In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving misoprostol and may be causally related to the drug: Nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for misoprostol and placebo.

Causal Relationship Unknown

The following adverse events were infrequently reported. Causal relationships between misoprostol and these events have not been established but cannot be excluded:

Body as a Whole: Aches/pains, asthenia, fatigue, fever, rigors, weight changes.

Skin: Rash, dermatitis, alopecia, pallor, breast pain.

Special Senses: Abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache.

Respiratory: Upper respiratory tract infection, bronchitis, bronchospasm, dyspnoea, pneumonia, epistaxis.

Cardiovascular: Chest pain, oedema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA).

Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase.

Hypersensitivity: Anaphylactic reaction.

Metabolic: Glycosuria, gout, increased nitrogen, increased alkaline phosphatase.

Genitourinary: Polyuria, dysuria, haematuria, urinary tract infection.

Nervous system/Psychiatric: Anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion.

Musculoskeletal: Arthralgia, myalgia, muscle cramps, stiffness, back pain.

Blood/Coagulation: Anaemia, abnormal differential, thrombocytopaenia, purpura, ESR increased.

Reproductive System and Breast Disorders: ******* haemorrhage (including postmenopausal bleeding), intermenstrual bleeding, menstrual disorder, uterine cramping, menorrhagia, dysmenorrhoea, uterine haemorrhage.

Congenital, Familial and Genetic Disorders: Birth defects.

Post-marketing Experience

The following adverse reactions have also been reported during post-approval use of mifepristone and misoprostol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. No causal relationship between these events and mifepristone and misoprostol has been established:

Allergic reaction (including rash, hives, itching, anaphylaxis, angioedema), hypotension (including orthostatic), syncope, fainting, dyspepsia, back pain, leg pain, anaemia, lightheadedness, loss of consciousness, anxiety, pain, post-abortal infection (including endomyometritis, parametritis, pelvic infection, pelvic inflammatory disease, salpingitis), uterine rupture, leukorrhoea, ruptured ectopic pregnancy, shortness of breath, and tachycardia (including racing pulse, heart palpitations, heart pounding), hematometra.

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on (pla Number) or you can report to PvPI on 1800 180 3024.

By reporting side-effects, you can help provide more information on the safety of this product.

Overdose

Mifepristone

No serious adverse reactions were reported in tolerance studies in healthy non-pregnant female and healthy male subjects where mifepristone was administered in single doses greater than 1800 mg (nine-fold the recommended dose for termination of pregnancy). In the event of accidental massive ingestion, she should be observed closely as signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone.

Misoprostol

The toxic dose of misoprostol in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. It is not known if misoprostol acid is dialyzable. However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage. In cases of overdose, standard supportive measures should be adopted as required.

Pharmacological Properties

Mechanism of Action

Mifepristone

Mifepristone (RU 486) is a synthetic steroid with an anti-progestational action as a result of competition with progesterone at the progesterone receptors.

Misoprostol

Misoprostol is a synthetic prostaglandin E1. At the recommended dosages, misoprostol induces contractions of the smooth muscle in the myometrium and relaxation of the uterine cervix. The uterotonic properties of misoprostol should facilitate cervical opening and evacuation of the product of conception.

Pharmacodynamic Properties

Mifepristone

In women at doses of > 1 mg/kg, mifepristone antagonises the endometrial and myometrial effects of progesterone. During pregnancy, it sensitizes the myometrium to the contraction-inducing action of prostaglandins. The maximum effect is achieved when prostaglandin was administered 36 to 48 hours after mifepristone.

During the first trimester, pre-treatment with mifepristone induces softening and dilatation of the cervix, that is detectable from 24 hours after administration of mifepristone and increases to a maximum at approximately 36 to 48 hours after administration. While clinical data have demonstrated that mifepristone facilitates dilatation of the cervix, no data is available to indicate that this results in a lowering of the rate of early or late complications to the dilatation procedure.

In the event of an early termination of pregnancy, the combination of a prostaglandin analogue used in a sequential regimen after mifepristone leads to an increase in the success rate to about 95% of the cases and accelerates the expulsion of the conceptus.

In clinical trials, according to the prostaglandin used and the time of application, the results vary slightly. Combinations of mifepristone with prostaglandin analogues other than misoprostol and gemeprost have not been studied.

Mifepristone binds to the glucocorticoid receptor. In animals at doses of 10 to 25 mg/kg it inhibits the action of dexamethasone. In man the anti-glucocorticoid action is manifested at a dose > 4.5 mg/kg by a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol. Glucocorticoid bioactivity may be depressed for several days following a single administration of 200 mg mifepristone for termination of pregnancy. The clinical implications of this are unclear; however, vomiting and nausea may be increased in susceptible women.

Mifepristone has a weak anti-androgenic action which only appears in animals during prolonged administration of very high doses.

Misoprostol

When administered vaginally, the increase in uterine tonus begins after about 20 minutes and reaches its maximum after 46 minutes. Uterine contractility increases continuously for 4 hours after ******* administration. ******* administration of misoprostol induces far more powerful and regular contractions than does oral administration.

In the event of an early termination of pregnancy, the combination of a prostaglandin analogue used in a sequential regimen after mifepristone leads to the expulsion of the conceptus. In clinical trials, the success rate is around 95% when 200 mg mifepristone is combined with misoprostol 800 mcg up to 63 days of amenorrhoea.

Pharmacokinetic Properties

Mifepristone

Absorption

Following oral administration of a single dose of 600 mg, mifepristone is rapidly absorbed, with a peak plasma concentration of 1.98 mg/L occurring approximately 90 minutes after ingestion. The absolute bioavailability of low doses of mifepristone (20 mg orally or intravenously) is 69%.

Distribution

Mifepristone is 98% bound to plasma proteins: albumin and alpha 1-acid glycoprotein. Binding to the latter protein is saturable, and the drug displays nonlinear kinetics with respect to plasma concentration and clearance. Following a distribution phase, elimination of mifepristone is slow at first (50% eliminated between 12 and 72 hours) and then becomes more rapid with a terminal elimination half-life of 18 hours.

Metabolism

Metabolism of mifepristone is primarily via pathways involving N-demethylation and terminal hydroxylation of the 17-propynyl chain. In vitro studies have shown that CYP450 3A4 is primarily responsible for the metabolism. The three major metabolites identified in humans are: (1) RU 42 633, most widely found in plasma, is the N-monomethylated metabolite; (2) RU 42 848, which results from the loss of two methyl groups from the 4-dimethylaminophenyl in position 11beta; and (3) RU 42 698, which results from terminal hydroxylation of the 17-propynyl chain.

Excretion

By 11 days after a 600 mg dose of a titrated compound, 83% of the drug has been accounted for by the faeces and 9% by the urine. Serum levels are undetectable by 11 days.

Misoprostol

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid (misoprostol acid), which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta-oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs.

In normal volunteers, misoprostol is rapidly absorbed after oral administration with a Tmax of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20 - 40 minutes.

There is the high variability of plasma levels of misoprostol acid between and within studies but mean values after single doses show a linear relationship with dose over the range of 200–400 mcg. No accumulation of misoprostol acid was noted in multiple-dose studies; plasma steady state was achieved within 2 days.

Maximum plasma concentrations of misoprostol acid are diminished when the dose is taken with food and the total availability of misoprostol acid is reduced by the use of concomitant antacid. Clinical trials were conducted with concomitant antacid; however, this effect does not appear to be clinically important. After oral administration of radiolabeled misoprostol, about 80% of detected radioactivity appears in the urine.

In contrast, after ******* administration, the plasma concentration gradually increased, reaching maximum levels after 70 - 80 minutes, and slowly declined with detectable levels present after 6 hours. ******* misoprostol was present in the circulation longer than oral misoprostol and hence its duration of stimulation of the uterus exceeds that of oral misoprostol. When misoprostol is administered vaginally, the plasma concentrations of misoprostol acid peak in 1 - 2 hours and then decline slowly. ******* application of misoprostol results in slower increases and lower peak plasma concentrations of misoprostol acid than does oral administration, but overall exposure to the drug is increased.

Non-Clinical Properties

Animal Toxicology or Pharmacology

Mifepristone

Mifepristone is shown to have no mutagenic potential and no toxic effect up to 1000mg/kg in acute administration performed in mice and rats. In toxicological studies in rats and monkeys up to a duration of 6 months, mifepristone produced effects related to its antihormonal (antiprogesterone, anti-glucocorticoid, and antiandrogenic) activity. In reproduction toxicology studies, mifepristone acts as a potent abortifacient. No teratogenic effect of mifepristone was observed in rats and mice surviving fetal exposure. In rabbits surviving fetal exposure, however, isolated cases of severe abnormalities occurred (cranial vault, brain, and spinal cord). The number of fetal anomalies was not statistically significant and no dose effect was observed. In monkeys, the number of fetuses surviving the abortifacient action of mifepristone was insufficient for a conclusive assessment.

Misoprostol

Single-dose toxicity studies in rodents and nonrodents indicate a safety margin of at least 500 to 1000-fold between lethal doses in animals and therapeutic doses in humans. Reproductive toxicity studies in animals have shown embryotoxicity at high doses.

Description



Pharmaceutical Particulars

Incompatibilities

Not applicable

Shelf-life

18 months

Packaging Information

5 tablets in a blister pack

MTP Kit contains 1 tablet of mifepristone and 4 tablets of misoprostol.

Storage and Handling Instructions

Store below 25oC.

Patient Counselling Information

What is MTP Kit and what is it used for?
MTP Kit is a combination therapy containing two medicines called mifepristone and misoprostol. MTP Kit is indicated for the medical termination of intrauterine pregnancy of up to 63 days gestation based on the first day of your last menstrual period.

Mifepristone is an anti-hormone that acts by blocking the effects of progesterone, a hormone that is needed for pregnancy to continue. Misoprostol is a prostaglandin, which is a substance that increases the contraction of the womb that will help expel the pregnancy. The two drugs can, therefore, cause termination of pregnancy and must be used one after the other to give the best possible chance for the treatment to work.

What do you need to know before you take MTP Kit?
Do not take mifepristone and misoprostol tablets if -

your pregnancy has not been confirmed by gynecological examination, ultrasound scan, or biological tests,
the first day of your last period was more than 63 days ago (if there is any doubt, the doctor can check the age of your pregnancy with a scanner),
your doctor suspects an extra-uterine pregnancy (the egg is implanted outside the womb),
you have bleeding disorders or are on blood-thinning drugs,
you have undergone genital cutting or circumcision,
you cannot return for a follow-up visit to assess that the pregnancy is completely terminated,
you cannot easily get emergency medical help in the 2 weeks after you take mifepristone and misoprostol,
you are allergic to mifepristone, misoprostol (or any other prostaglandins), or any of the other ingredients of this medicine,
you suffer from severe asthma which cannot be adequately treated with medication,
you have hereditary porphyria (an inherited disorder of the blood),
you suffer from chronic adrenal failure
you have an intrauterine device (this must be removed prior to administering mifepristone tablet)
Warnings and Precautions