Unwanted Kit For 2 Month Pregnancy How To Use?

Unwanted Kit For 2 Month Pregnancy How To Use
The dosage system consists of 1 tablet of Mifepristone, followed by Misoprostol after 1-3 days. If termination of pregnancy fails to occur after taking Misoprostol(1 tablet), then the second dose of Misoprostol (2 tablets) is recommended.
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When can we use unwanted kit?

MTP Kit is a combipack of 1 tablet of mifepristone and 4 tablets of misoprostol. It 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. Mifepristone (RU 486) is a synthetic steroid with an anti-progestational action as a result of competition with progesterone at the progesterone receptors.

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

The dosage is mifepristone 200 mg orally followed 1 – 3 days later by misoprostol 800 mcg (4 tablets of 200 mcg) vaginally. The patient should return for a follow-up visit approximately 14 days after the administration of mifepristone. 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. For the use of Gynaecologists only 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. Each pack contains 5 tablets: A.1 Mifepristone Tablet Each uncoated tablet contains: Mifepristone200 mg B.4 Misoprostol Tablets Each uncoated tablet contains: Misoprostol200 mcg Mifepristone tablet for oral use and misoprostol tablets for vaginal use.

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. 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. 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.

  • 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.

  • 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 vaginal bleeding and uterine cramping probably will occur
  • that prolonged heavy vaginal 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 / Vaginal Bleeding Uterine / vaginal bleeding occurs in almost all patients during a medical abortion.

The patient must be informed of the occurrence of prolonged vaginal 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.

  • 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 vaginal bleeding following a medical abortion. Women should expect to experience vaginal 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 vaginal 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 / vaginal 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 vaginal 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 vaginal administration of misoprostol tablets for oral use. It cannot be excluded that this infection may occur also with vaginal 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 (vaginal 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 vaginal 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.

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).

  1. Furthermore, rifampin, dexamethasone, St.
  2. John’s Wort, and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of mifepristone).
  3. Whether this action has an impact on the efficacy of the dose regimen is unknown.
  4. 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 C max ) 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. Patients with Renal Impairment Mifepristone The effects of renal disease on the safety, efficacy and pharmacokinetics of mifepristone have not been investigated.

  1. Mifepristone is not recommended in patients with renal impairment.
  2. 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.
  3. Patients with Hepatic Impairment Mifepristone The effects of hepatic disease on the safety, efficacy and pharmacokinetics of mifepristone have not been investigated.
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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.

  1. Pregnant Women 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.
  2. 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 vaginal 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).

  • 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.

  1. Birth defects have been reported with a continued pregnancy after a failed pregnancy termination with Mifepristone tablets, 200 mg in a regimen with misoprostol.
  2. 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.

  1. Many hormones with a similar chemical structure, however, are excreted in breast milk.
  2. However, no data is available.
  3. Consequently, mifepristone and misoprostol use should be avoided during breastfeeding.
  4. 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. 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.

  1. Mifepristone The treatment procedure is designed to induce the vaginal bleeding and uterine cramping necessary to produce an abortion.
  2. 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.
  3. 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. Vaginal 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 vaginal 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 vaginal 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 : Vaginal 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 [email protected]. You can also report side effects directly via the national pharmacovigilance program of India by calling on 18002677779 (Cipla 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. 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. 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 E 1, 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. 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 vaginal administration. Vaginal 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. 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-monodemethylated 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 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 analogues. In normal volunteers, misoprostol is rapidly absorbed after oral administration with a T max of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20 – 40 minutes. There is 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 total availability of misoprostol acid is reduced by 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 urine. In contrast, after vaginal administration, the plasma concentration gradually increased, reaching maximum levels after 70 – 80 minutes and slowly declined with detectable levels present after 6 hours. Vaginal 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. Vaginal 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. 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 foetal exposure. In rabbits surviving foetal exposure, however, isolated cases of severe abnormalities occurred (cranial vault, brain and spinal cord). The number of foetal anomalies was not statistically significant and no dose effect was observed. In monkeys, the number of foetuses 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. MTP 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. Not applicable 18 months 5 tablets in a blister pack MTP Kit contains 1 tablet of mifepristone and 4 tablets of misoprostol, Store below 25 o C.

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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 which is needed for pregnancy to continue.

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 In some circumstances the treatment may not be suitable for you, so please tell your doctor if:

  • you have a heart complaint,
  • your heart has been fitted with an artificial valve,
  • you have a risk factors for heart diseases, such as high blood pressure or high blood cholesterol levels (increased fat content in your blood),
  • you suffer from asthma,
  • you suffer from an illness that may affect the clotting of your blood,
  • you have liver or kidney disease,
  • you are anaemic or otherwise malnourished.

The doctor will then be able to discuss with you if you are able to have the treatment. Other Medicines and MTP Kit Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, medicines containing the following active substances may interfere with the action of mifepristone and misoprostol:

  • corticosteroids (used to treat asthma or inflammation),
  • ketoconazole, itraconazole (used in antifungal treatment),
  • erythromycin, rifampicin (antibiotics),
  • St John’s Wort (natural remedy used to treat mild depression),
  • phenytoin, phenobarbital, carbamazepine (used to treat seizures or epilepsy).

The incidence of diarrhoea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminium or calcium may be a more appropriate choice. Ask your doctor about which medicines you can take for pain. Talk to your doctor if you need to take any other medicines during the treatment.

  1. MTP Kit with Food and Drink You should not drink grapefruit juice when you are treated with mifepristone and misoprostol.
  2. Pregnancy and Breastfeeding Mifepristone and misoprostol may pass into breast milk and be taken in by your baby.
  3. You should stop breast feeding once you have taken the treatment.
  4. There is little information on the risks to the unborn baby.

If the pregnancy continues and you decide to keep it, discuss this with your doctor who will arrange careful pre-natal monitoring and ultrasound examinations. It is recommended that you avoid becoming pregnant again before your next menstrual period after taking mifepristone and misoprostol.

How to Take MTP Kit

  • For pregnancies that have occurred with an intrauterine contraceptive device (coil) in place, this must be removed prior to administering mifepristone and misoprostol.
  • It is recommended that you do not travel too far away from the prescribing hospital/clinic until the follow-up visit date. In an emergency or if you are worried for any reason, you can contact or return to the hospital/clinic before the appointment time. You will be given the telephone number to call for emergencies or any problems.

The use of mifepristone and misoprostol tablets requires your active participation as follows: First Visit to the Hospital / Clinic

  • You will be given one tablet of mifepristone 200 mg to swallow with some water in the presence of a doctor.
  • You will be able to go home after taking the tablet of mifepristone once the doctor is sure that you will not be sick. If you experience symptoms such as severe abdominal pain, fainting, fast heartbeat, fever lasting more than 4 hours after taking the tablet, please tell your doctor.
  • In rare cases, the pregnancy may be expelled before you take the misoprostol tablets. It is essential that you return to the hospital/clinic to confirm that a complete pregnancy termination has occurred.

Follow-up Visit

  • You must return to the hospital/clinic 1-3 days after taking mifepristone, as directed by your doctor.
  • You will be given 4 vaginal tablets of misoprostol to ensure the treatment is effective. The tablets will be placed into your vagina or you may do this yourself. In this case, please make sure that you empty your bladder and clean your hands thoroughly before inserting the misoprostol vaginal tablets. Push the four vaginal tablets one at a time up into the vagina as far as you can using your finger. It is recommended that you lie down for about 30 minutes after the misoprostol vaginal tablets have been inserted.
  • You should stay in the hospital/clinic for a few hours or until you and the doctor are happy that you are well enough to go home. The pregnancy may be expelled within a few hours or during the next few days after misoprostol treatment.

Third Visit

  • You must return to the hospital/clinic for a check-up within approximately 14 days of taking the mifepristone tablet.
  • It is important that you keep this appointment to check that your pregnancy has been completely expelled and you are well, as you will not be able to judge for yourself if the treatment has been successful.

After Treatment you Should be Aware that

  • Uterine bleeding usually starts 1 to 2 days after taking the mifepristone tablet. The bleeding lasts 2 or 3 weeks (on average 13 days). If the bleeding is heavy and prolonged, contact the doctor immediately for an earlier appointment.
  • The presence of these bleedings is not related to the success of the method. If pregnancy continues or expulsion is incomplete, you will be offered a surgical method for terminating the pregnancy.
  • If the pregnancy continues and you decide to keep it, discuss this with your doctor who will arrange careful pre-natal monitoring and ultrasound examinations.
  • Important: It is possible for you to become pregnant again very soon after the pregnancy termination is complete. It is recommended that you avoid getting pregnant again soon after the termination. You should therefore start using a method of contraception within 3 to 9 days of taking the mifepristone tablet. Discuss contraceptive options with your doctor.

The use of mifepristone and misoprostol requires that measures are taken to prevent Rhesus factor sensitisation (if you are Rhesus negative) along with the general measures taken during any pregnancy termination. If you Take More Mifepristone and Misoprostol than you Should As you will be supervised during administration of the treatment, it is unlikely that you will take more than you should.

Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious Side Effects Contact the hospital/clinic if you have:

  • tearing of the womb after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous deliveries of a child or with a scar of a caesarean section.
  • persistent heavy bleeding, for example soaking two sanitary pads per hour, for more than two hours
  • persistent fever with a temperature of 38°C or higher, for more than four hours
  • an unpleasant smelling discharge
  • persistent pain unrelieved by medication.

Contact your doctor if any of the following side effects gets serious or you are worried. Very Common Side Effects (may affect more than 1 in 10 people)

uterine contractions or lower abdominal cramps in the hours following misoprostol.

Common Side Effects (may affect up to 1 in 10 people)

  • heavy bleeding
  • gastrointestinal cramping, light or moderate
  • nausea, vomiting or diarrhoea.

Uncommon Side Effects (may affect up to 1 in 100 people)

  • infection following abortion
  • hypersensitivity: skin rashes.

Rare Side Effects (may affect up to 1 in 1,000 people)

  • headaches
  • malaise (feeling unwell)
  • hot flushes, dizziness, chills
  • fever
  • low blood pressure
  • hives and skin disorders, which can be serious.

Very Rare Side Effects (may affect up to 1 in 10,000 people)

fatal toxic shock caused by infection by Clostridium sordellii endometritis, presenting without fever or other obvious symptoms of infection.

Reporting of Side Effects If you experience any side-effects, talk to your doctor or pharmacist or write to [email protected]. You can also report side effects directly via the national pharmacovigilance program of India by calling on 18002677779 (Cipla Number) or you can report to PvPI on 1800 180 3024.

How to store MTP Kit

Store below 25°C.

Contents of the pack and other information

What does MTP Kit contain MTP Kit contains 1 tablet of mifepristone 200 mg and 4 tablets of misoprostol 200 mcg each. Mifepristone 200 mg tablet is a yellowish, uncoated, circular, biconvex that is plain on both sides. Misoprostol 200 mcg tablets are white to off white, capsule shaped, biconvex, uncoated with central break-line on one side and plain on other side.
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How do you use unwanted?

Special Advise –

Take Unwanted-72 Tablet 1’s preferably within 72 hours (3 days) of having unprotected sex or contraceptive failure.Contact your doctor immediately if you experience heavy vaginal bleeding after taking this medicine.Consult your doctor if your periods are delayed by more than 7/10 days for a pregnancy test.

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How many tablets are in an unwanted kit?

What is the Unwanted-Kit Dosage? – Unwanted-Kit comes in the combination of 1 pill of Mifepristone (200mg) and 4 pills Misoprostol (200 mcg each so a total of 800mcg). The recommended dosage varies based on how far along the pregnancy is.
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Do I have to take 2 doses of misoprostol?

Between 13 and 22 weeks LMP – – Due to an increased risk of complications, admit patient for observation after 12 weeks LMP, however, between 13 and 16 weeks LMP the woman can choose to take the treatment at home, unless there is a risk of uterine rupture ( Section 12.2.1 ).

  • As gestational age increases, expulsion takes more time and is more painful (ensure pain management accordingly).
  • The foetus is more developed and is usually stillborn.
  • In exceptional cases, transient spontaneous breathing and/or movements may be observed.
  • This may be emotionally difficult for both the woman and medical staff.

– The disposal of the dead foetus must be handled discreetly and respectfully. – For women 13-16 weeks LMP who chose to take the treatment at home, provide necessary information and counselling as above, including considerations regarding the disposal of the foetus.
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What to do if you are 4 weeks pregnant and don t want the baby?

– Unwanted pregnancy isn’t uncommon. Almost half of all pregnancies in the United States are unintended, according to a 2016 study, If you become pregnant and you’re either not ready to be a parent or you don’t want to have a baby, know that you’re not alone and you do have options.

  • You can choose to terminate the pregnancy with an abortion or put your baby up for adoption.
  • It’s a big choice and one that can feel overwhelming.
  • Remember, the “right” decision is the one that’s healthiest for you, and only you can determine that.
  • If you know you don’t want to have a baby but are unsure of what to do next, it’s OK to ask for help.

Your spouse, partner, friends, other supportive family members, or a therapist can help talk you through the decision. A doctor can also help guide you through this process and recommend appropriate resources.
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Which tablet is used to stop early pregnancy?

Descriptions – Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.

Tablet

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Why do we use unwanted 21 days?

Product introduction – Unwanted 21 Days Tablet is a medicine used for contraception (to prevent pregnancy) and in the treatment of irregular periods. It helps to prevent the release of the egg and its fertilization by the sperm. Unwanted 21 Days Tablet can be taken with or without food, but take it at the same time to get the most benefit.

It should be taken as per your doctor’s advice. You will have to take the pill on day one of your menstrual cycle and continue taking it for a whole month. Once the pack gets over, start with a new one. If you experience vomiting within 4 hours of dose intake, take another tablet. In case you missed your dose and you are late by 12 hours in taking the missed dose, use a condom during intercourse for a period of 2 days.

Nausea, headache, and breast pain are some commonly seen side effects of this medicine. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. You might experience spotting or bleeding between menstrual periods or missed periods.

Consult with your doctor if this occurs frequently or persists longer. Inform your doctor if you notice swelling and pain in your limbs, shortness of breath, chest pain, or changes in vision, as it may be a sign of a blood clot. Before taking this medicine, let your doctor know if you smoke and are over 35, or if you have ever had a heart attack or have cancer of the uterus/cervix, or vagina.

Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. Do not take the medicine if you are pregnant already or breastfeeding.
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Does unwanted 72 works after 7 days?

The Onset of Action: – Unwanted 72 pills should be taken within 72 hours of having unprotected sex. The sooner the pill is taken, the better will be the effectiveness. The effectiveness of the pill will be better if taken after 24 hours of unprotected sex. It is not effective if taken after 72 hours as the egg is already fertilized in 3 days’ time.
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What is the side effect of unwanted kit?

Q. What are the common side effects of taking Mtp Kit? – The common side effects of using Mtp Kit are abdominal pain, abdominal cramping, nausea, diarrhea, dizziness, uterine contractions, pelvic pain, and shivering. If you experience a very heavy vaginal bleeding or if any of these side effects bother you please consult with your gynecologist. Show more Show less
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How do you take the pill for 21 days?

At a glance: the combined pill –

When taken correctly, the pill is over 99% effective at preventing pregnancy. This means that fewer than 1 in 100 who use the combined pill as contraception will get pregnant in 1 year.The standard way to take the pill is to take 1 every day for 21 days, then have a break for 7 days, and during this week you have a bleed like a period. You start taking the pill again after 7 days.You may be able to take some types of pill with no or shorter breaks (a tailored regime), which may reduce some side effects. Speak to a doctor or nurse about your options.You need to take the pill at around the same time every day. You could get pregnant if you do not do this, or if you miss a pill, or vomit or have severe diarrhoea.Some medicines may make the pill less effective. Check with your doctor if you’re taking any other tablets.If you have heavy periods or painful periods, PMS (premenstrual syndrome) or endometriosis the combined pill may help.Minor side effects include mood swings, nausea, breast tenderness and headaches – these usually settle down in a few months.There is no evidence that the pill will make you gain weight.There’s a very low risk of serious side effects, such as blood clots and cervical cancer.The combined pill is not suitable if you are over 35 and smoke, or if you have certain medical conditions.The pill does not protect against sexually transmitted infections (STIs), so use a condom as well.There may be a link between the pill and depression but evidence is mixed and further research is needed.

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Can unwanted 72 stop pregnancy?

Q. How effective is Unwanted 72? – This tablet is not 100% effective in preventing pregnancy. However, the sooner you take it, the more effective it will be as it can significantly reduce your chances of becoming pregnant if used within 72 hours (3 days) after unprotected sex or contraceptive failure.
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How can I take unwanted 72 days?

Effective use of this medicine Unwanted 72 0.75 MG Tablet is effective if taken at the earliest. It should be taken within 72 hours of having unprotected sex or contraception failure. It should not be used as a routine birth control method.
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Can I take 2 tablets of misoprostol at a time?

Proper Use – For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects.

  1. Do not change the dose or stop using this medicine without checking first with your doctor.
  2. This medicine should come with a patient information leaflet.
  3. Read and follow these instructions carefully.
  4. Ask your doctor if you have any questions.
  5. Misoprostol is best taken with or after meals and at bedtime, unless otherwise directed by your doctor.

To help prevent loose stools, diarrhea, and abdominal cramping, always take this medicine with food or milk. Do not give this medicine to another person.
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How many Ipills are required?

1. How many I-Pills should be taken? One tablet of I-Pill within 24/72 hours of unprotected sex or contraception failure is enough.
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What is the price of unwanted kit?

296.00 Rs.394 24.87% Off. Prescription required on this product. Unwanted Kit Tablet should be taken with food or as your doctors advice.
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Why is my stomach swollen after abortion?

Instructions for After Your Abortion Pregnancy termination as performed at Woman’s Health Centers is a relatively simple procedure. However, like other surgical operations, complications can occur through no fault of the doctor or medical attendants. Although these complications do not happen often, it is important that you know what to expect and what to do just in case one of these situations occur.

Fever Take your temperature with a thermometer each afternoon and evening for the next five days. If it is 100 degrees or higher, **call your Health Center promptly. A fever may mean that you are getting an infection and it is URGENT that you report it at once so you can be treated. Infection is the most frequent complication after an abortion.

About 1 patient in every 100 patients experiences some degree of infection. In most cases, the infection is noticed within three days after the surgery and it can usually be treated simply and effectively with antibiotics. Bleeding Excessive bleeding is a less frequent complication.

  • The normal amount of bleeding is different for each woman.
  • Some women may have very little bleeding or no bleeding at all for several days and suddenly, they can experience an increase after day 5 to 6.
  • Many women will have heavier bleeding, much like a period, which may last 3-5 days after the surgery.

Some woman spot bleed for 2-4 weeks. Some do not bleed at all. You may pass large or small clots and bleeding may seem to increase when you get up suddenly or go to the toilet. The flow may also increase after you have stopped taking the methergine pills.

If the amount of bleeding increases to the point that you are soaking more than one pad per hour, call TWHC promptly. Note: Your first period will occur in 4-12 weeks. Cramping Cramping is usually caused by the uterus contracting to control bleeding. Do not be concerned if you experience mild cramping for several days.

Cramping may be felt in the lower abdomen, back, inner thighs or legs. You should be able to get relief by taking 800mg of Ibuprofen, a non-aspirin medicine, or by using a heating pad or hot water bottle. You have been given a prescription for pain medication.

Have it filled at your pharmacy and take it as directed, if needed, for cramping. Alternate your pain medication with 3 doses per day of 800mg ibuprofen. If the cramping is severe or constant, and you are not able to get relief from any of these methods, call TWHC immediately. Swelling You may notice some abdominal swelling or bloating following your procedure.

Some swelling is normal and may last for 3 to 5 days. If the swelling is accompanied by tenderness, fever, chills, severe cramping or excessive bleeding, it is not normal and you should call TWHC immediately. Problems Call immediately if you have any problems (fever, excessive bleeding or cramping), which may indicate complications.

A member of the WHC staff is available for emergency calls during the hours when the center is not open. Answering services are in great demand and sometimes very busy. Sometimes it is necessary to let the phone ring several times. If the phone is not answered, hang up and call the number again. If you need information and it is NOT an emergency, please call the center directly between the hours of 8:00am and 5:00pm, Monday through Friday.

What to Know When You Call

Your temperature within the last hour. The number of sanitary pads that you have soaked within the last 3 hours. The telephone number of your pharmacy.

If you are having problems, it is best to contact the center early in the day when pharmacies in your area are still open. For all emergencies related to your abortion, call the center or the emergency number on this information sheet. Do not go to the emergency room of a hospital.

  • This would only result in additional cost to you and is almost always unnecessary,
  • Because of the long history if frequent, serious complications related to unskilled, illegal abortions, some physicians in the past have felt that women should be hospitalized for heavy bleeding, cramping or fever.
  • Current medical experience suggests that most complications can be treated effectively with medication, without requiring a hospital visit.

If hospitalization is necessary, we will be glad to fully inform your physician about the your abortion procedure. To Prevent Infection After your surgery, you can reduce the risk of getting an infection by making a few temporary changes to your lifestyle.

Tampons Intercourse Tub baths Jacuzzis/Hot tubs Swimming Douching

Sanitary pads (maxipads) Showers only

Not OK for 1 Week OK for 1 Week

Exercising Heavy lifting Strenuous Activity

Keep in mind, the more active you are for the first 5-7 days following your abortion, the more bleeding and cramping you may experience. Medication Information You may have been given an antibiotic to prevent infection and/or methergine to contract your uterus.

  • If so, begin taking both of them today.
  • Follow the directions given on the prescription bottles.
  • Take all your medicines with food.
  • Your Feelings During pregnancy, a woman’s body goes through a hormonal change which may cause moodiness.
  • After a pregnancy is ended, either by childbirth or abortion, the body again goes through some changes.

You may have some depression or a “blue day” or two during the week following the abortion. If you are troubled by negative thoughts or feelings about the abortion a month or two afterwards, please return to the center and let us give you a referral to a qualified mental health counselor.

  1. Abortion does not cause mental health issues.
  2. Post Abortion Check-up To be sure that your body is back to normal after your abortion, you are required to return for a post abortion examination.
  3. If you do not keep your appointment, your health and well being may be in danger.
  4. The center, its staff, and the attending physician(s) cannot be held responsible for your care after your abortion if you do not show up for this scheduled appointment.

This WARNING is for your own benefit. Please take care of yourself by keeping this important post abortion checkup appointment. This check-up is a free service provided by the center. : Instructions for After Your Abortion
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How long will cramps last after abortion?

When can I resume my normal activities after undergoing a procedure? Will I bleed and cramp? What if I still feel pregnant? What complications may occur? How can I avoid infection? After the procedure, when will my menstrual period begin? Should I schedule a follow-up appointment?

When can I resume my normal activities after the procedure? You should go home and rest after the procedure. Resume normal activities the following day. Avoid activity that causes increased pain. If you receive oral relaxation or narcotic pain medications for the procedure, don’t drive a car for eight hours.

If you receive intravenous (IV) medications during the procedure, don’t drive a car for 24 hours. Will I bleed or cramp? You may bleed up to a week or off and on up to four weeks after the procedure. The flow may vary from very light to fairly heavy. It may increase with exercise and decrease with rest.

Small blood clots are normal. Clots can appear red to dark purple. Use sanitary pads only, not tampons, for bleeding after the procedure. You may experience cramps for a few days. Some women experience an episode of heavy bleeding and cramps four to six days after the procedure.

  1. Call the UCSF Center for Pregnancy Options if bleeding is prolonged or extremely heavy.
  2. Blood-tinged discharge is common as bleeding slows.
  3. Discharge may appear as yellow or brown and may have a sour odor.
  4. To relieve cramps, take ibuprofen (up to 800 mg every six hours) or Tylenol (up to 1,000 mg every four hours).

Rest as well as a hot water bottle or heating pad on the abdomen can help. What if I still feel pregnant? Pregnancy symptoms of nausea, vomiting and weariness usually cease within three days. Breast tenderness may take seven to 10 days to disappear. Your breasts may feel firm and tender and leak fluid after your procedure.

Your breasts will return to normal after three to four days of swelling. You will feel more comfortable if you wear a supportive bra and apply cold ice packs to your breasts. Take ibuprofen or Tylenol, if necessary, for pain. If you still feel pregnant after a week, call the UCSF Women’s Option Center at (415) 353-7003 to speak to one of our health care providers.

What complications may occur? If you experience any of the following symptoms, call the Women’s Options Center to talk to a doctor or nurse.

Fever over 100 degrees or chills Excessive bleeding (soaking one pad per hour for three straight hours) Bad cramps unrelieved by ibuprofen or Tylenol or prolonged abdominal pain

A doctor can be reached at any time.

Monday to Friday during business hours, call (415) 353-7003 Nights, weekends and holidays, page a doctor by calling (415) 719-6318. At the beep, enter the phone number you want the doctor to call, then press the # key.

How can I prevent infection? To decrease the chance of pelvic infection, please follow these instructions:

Take your antibiotic medication as directed. Don’t have vaginal intercourse and don’t insert anything, including tampons, in your vagina for two weeks with one exception. If you use NuvaRing as your birth control, you may insert it after the procedure. Do not douche, taking baths or swim. You may shower, but do not sit in a tub of water.

After the procedure, when will my menstrual period begin? Your next menstrual period should begin four to seven weeks after the procedure. You can get pregnant before then and should use birth control when you resume sexual intercourse. Your first few cycles may be irregular.

  • If you use a cyclic hormonal birth control method — such as the pill, patch or ring — you should start the method the same day as your procedure.
  • Your next period will occur during the fourth week of the contraceptive cycle.
  • Should I schedule a follow-up appointment? It’s not necessary to see a doctor after your procedure, unless you experience complications.

We recommend that you make an appointment to see your primary care doctor or gynecologist if you are due for an annual Pap smear, physical or gynecologic exam, need birth control prescription refills or would like to discuss your fertility.
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How much bleeding is normal 3 days after abortion?

After an aspiration abortion: – Important: Do not drive or make any important decisions for 24 hours. Take care of yourself. Do:

Rest for today and take it easy for the next 24 – 48 hours Drink lots of fluids and eat well-balanced meals If you must travel for more than 1 hour, get up, stretch your legs and walk around for 5 – 10 minutes for every hour of travel

Avoid:

Heavy exercise and heavy lifting for 3 – 4 days Alcohol and street drugs for 48 hours Smoking for 2 hours after your procedure – it may make you dizzy Inserting anything into your vagina for 1 week Listen to your body – it will let you know when you’re ready to return to your usual activities

What to Expect:

Bleeding, blood clots and cramps are all normal after an abortion.

Bleeding:

May be light or none for the first 3 days after an abortion May become heavier on the 4th or 5th day with clots, dark bleeding and cramps Can range from no bleeding to a very heavy menstrual period Light bleeding or spotting may last 2 – 4 weeks after an abortion May increase with physical activity

Blood Clots:

Could be as large as a lemon any time within 4 weeks following your abortion

Cramps:

Happens because the uterus is returning to its usual size Lessens if you rest and apply a hot water bottle or heating pad Take ibuprofen (Motrin® or Advil®) or naproxen (Aleve®) for pain Do not take ASA (Aspirin®) for pain – it may increase bleeding

Call the emergency number you were given at your appointment or proceed to the nearest emergency room if you:

Soak 4 or more maxi pads in 2 hours Pass very large blood clots (larger than the size of a lemon) Have a fever: 38.0° C or 100.4° F or higher Have chills or shaking Have unusually coloured vaginal discharge (yellowish or greenish) or bad odour

Still feel pregnant 2 weeks after your abortion? Where to get help: Our staff can help you by telephone at 204-947-2422 ext.200. You can also:

Call Health Links 204-788-8200 or 1-888-315-9257 Go to the Emergency Department (HSC if in Winnipeg) or your nearest hospital

The following are normal after an abortion: Within 24-48 hours

Nausea, vomiting and breast tenderness lessen. Nipples may leak fluid.

Within 1-2 weeks

Pregnancy symptoms (fatigue, bloating, and mood changes) lessen.

Within 4-6 weeks
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What is the process after taking abortion pill?

What happens during a medication abortion? – The abortion pill process has several steps and includes two different medicines. First, you take a pill called mifepristone, This medicine stops the pregnancy from growing. Some people feel nauseous or start bleeding after taking mifepristone, but it’s not common.

  • Your doctor or nurse may also give you antibiotics to take to prevent infection.
  • The second medicine is called misoprostol,
  • You’ll either take the misoprostol right away, or up to 48 hours after you take the first pill — your doctor or nurse will let you know how and when to take it.
  • This medicine causes cramping and bleeding to empty your uterus.

For most people, the cramping and bleeding usually starts 1-4 hours after taking the misoprostol. It’s normal to see large blood clots (up to the size of a lemon) or clumps of tissue when this is happening. It’s kind of like having a really heavy, crampy period, and the process is very similar to an early miscarriage.

  1. If you don’t have any bleeding within 24 hours after taking the second medicine, misoprostol, call your nurse or doctor.) The cramping and bleeding can last for several hours.
  2. Most people finish passing the pregnancy tissue in 4-5 hours, but it may take longer.
  3. The cramping and bleeding slows down after the pregnancy tissue comes out.

You may have cramping on and off for 1 or 2 more days. You can take pain medicine like ibuprofen about 30 minutes before you take the second medicine, misoprostol, to help with cramps. You can also take anti-nausea medicine if your doctor or nurse gives it to you.

  1. Don’t take aspirin, because it can make you bleed more.
  2. It’s normal to have some bleeding and spotting for several weeks after your abortion.
  3. You can use pads, tampons, or a menstrual cup — whatever’s the most comfortable for you.
  4. But your nurse or doctor may recommend you use pads for the first few days after the abortion so you can track how much you’re bleeding.

The last step is a follow up with your nurse or doctor. You may go back into the health center for an ultrasound or blood test. Or you’ll get a pregnancy test to take at home, followed by a phone call with your nurse or doctor. These tests will make sure the abortion worked and that you’re healthy.
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When is the first abortion pill taken?

What is the timeline for taking the abortion pill? – The abortion pill may be taken up until the 11th week of pregnancy. As for how early a woman can take it, waiting until the 6th week of pregnancy is often required. Before the 6th week, the risk of miscarriage is high, but once that 6th-week mark has been passed, it drops to only 10%, Unwanted Kit For 2 Month Pregnancy How To Use
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