MTP Kit (Abortion Pills ) 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. An 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 (Abortion Pills) fails to cause termination of intrauterine pregnancy.
Mifepristone (RU 486) may be administered by or under the supervision of a Gynaecologist, able to assess the gestational age of an embryo and 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.
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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 prostaglandins (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.