Specification :

Brand Name MTPill
Generic Name Mifepristone Tablet
Contents Each uncoated tablet contains Mifepristone … … .. 200 mg
Packing Pack of 3 tabs f
Description:

INDICATIONS

MTPill is indicated for the medical termination of intrauterine pregnancy through 49 days pregnancy. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 days cycle with ovulation occurring at mid-cycle.

The duration of pregnancy may be determined from menstrual history and by clinical examination. Ultrasonographic scan should be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.
Any intrauterine device [ “ IUD� ] should be removed before treatment with MTPill begins. Patients taking MTPill must take 400 mcg of misoprostol two days after taking mifepristone unless a complete abortion has already been confirmed before that time ( see DOSAGE AND ADMINISTRATION) .
Pregnancy termination by surgery is recommended in cases when MTPill and misoprostol fail to cause termination of intrauterine pregnancy.

DOSAGE AND ADMINISTRATION

Treatment with Mifepristone ( MTPill ) requires concurent administration of misoprostol. Treatment with MTPill and misoprostol for the termination of pregnancy requires three doctor visits by the patient. MTPill may be administered only in a clinic, medical office, or hospital, 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.

Day One: MTPill Administration
Three 200 mg tablets ( 600 mg) of MTPill are taken in a single oral dose.

Day Three: Misoprostol Administration
The patient returns to the healthcare provider two days after ingesting MTPill . Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200-mcg tablets ( 400 mcg) of misoprostol orally.
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 the misoprostol.

Day 14: Post-Treatment Examination
Patients will return for a follow-up visit approximately 14 days after the administration of MTPill . This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Patients who have an ongoing pregnancy at this visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

CONTRAINDICATIONS

Administration of MTPill and misoprostol for the termination of pregnancy ( the “ treatment procedure� ) is contraindicated in patients with any one of the following conditions:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass ( the treatment procedure will not be effective to terminate an ectopic pregnancy)
* IUD in place
* Chronic adrenal failure
* History of allergy to mifepristone, misoprostol or other prostaglandin
* Haemorrhagic disorders or concurrent anticoagulant therapy
* Inherited porphyria
Because it is important to have access to appropriate medical care if an emergency develops, the treatment procedure is contraindicated if a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the administering physician.