Terminex

Generic

Mifepristone + Misoprostol

 

Indications

This kit is for early Menstrual Regulation (MR) and pregnancy termination up to 9 weeks (63 days) of pregnancy.

 

Pharmacology

Mifepristone: Mifepristone is a synthetic steroid with anti-progestin activity and is produced due to a competitive interaction with progesterone at the progesterone receptor site. Based on studies of different oral doses in different animal species, this compound can inhibit endogenous or exogenous progesterone activity and menstrual regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

 Misoprostol: Misoprostol is a synthetic prostaglandin E1 analogue. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction causes a change in calcium concentration, which triggers muscle contraction. By interacting with prostaglandin receptors, misoprostol causes softening of the cervix and contractions of the uterus, thereby expelling the contents of the uterus.

 

Dosage & Administration

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. 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.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 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 fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

 

Interaction

Mifepristone: Although specific medication or food interactions with Mifepristone have not been examined, CYP 3A4 metabolism of this drug suggests that ketoconazole, itraconazole, erythromycin, and grapefruit juice may decrease its metabolism (increasing serum levels of mifepristone).

Misoprostol: It has not been established that misoprostol interferes with aspirin's positive effects on rheumatoid arthritis signs and symptoms. Misoprostol has no clinically relevant impact on aspirin absorption, blood levels, or antiplatelet effects when used in therapeutic doses.

 

Contraindications

Mifepristone should not be administered to patients who have any of the following conditions: IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, history of allergy or known hypersensitivity to Mifepristone, Misoprostol, or other prostaglandins, 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, haemorrhagi During the period from the initial visit to discharge, if a patient does not have enough access to medical facilities equipped to give emergency treatment of incomplete processes, blood transfusions, and emergency resuscitation,

 

Side Effects

Mifepristone: This medication is used to cause vaginal bleeding and uterine cramping, both of which are important for menstrual regulation (MR). Nausea, vomiting, and diarrhoea were the most commonly reported side effects. Pelvic pain, fainting, headaches, dizziness, and asthenia were all reported on a very rare basis.

Shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), shivering, hyperthermia, dizziness, shivering, hyperthermia, dizziness, shivering, hyperthermia, dizziness, shivering, hyperthermia.

 

Pregnancy & Lactation

Mifepristone for pregnancy: for menstrual regulation (MR) (63 days gestation), and there are no other approved indications for use during pregnancy. Patients who have been pregnant during the last visit are at risk for fetal malformations due to treatment. It is recommended to finish the operation to control the failure of the menstrual regulation (MR) treatment.

 Lactation period

 Mifepristone: It is not known whether mifepristone is excreted in human milk. However, many hormones with similar chemical structures are excreted in human milk. Since the effect of mifepristone on the baby is unclear, breastfeeding women should consult a doctor to determine if they should discard breast milk a few days after taking the drug.

 Misoprostol: Although it is not known whether misoprostol or misoprostol are excreted in human milk, misoprostol should not be administered to nursing mothers because the possible excretion of misoprostol can cause diarrhea in infants.

 

Precautions & Warnings

Patients should not give the combination of mifepristone and misoprostol to other people. The combination of mifepristone and misoprostol has been prescribed for the specific conditions of the patient, which may not be the correct treatment for others, and may be dangerous to others regardless of pregnancy. Before starting mifepristone treatment, any intrauterine device [IUD] must be removed. In cases where the combination of mifepristone and misoprostol does not cause menstrual regulation (MR), surgical regulation of menstruation (MR) is recommended. Patients who continued to be pregnant at the last visit are at risk of developing fetal malformations due to treatment. It is recommended to monitor menstrual regulation (MR) / termination failure through surgical termination / MVA.

 

Therapeutic Class

Drugs acting on the Uterus, Prostaglandin analogs

 

Storage Conditions

Store in a cool and dry place, protected from light.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.