Each box contains 2 blister strips. Mifton® strip : Each strip contains 1 tablet of Mifepristone INN 200 mg. Misotol® strip : Each strip contains 4 tablets of Misoprostol USP 200 microgram each.
Pack Size: 5 Pcs
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Information about MM Kit (200mg/200mcg)
MM Kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.
COMPOSITION OF Mifepristone & Misoprostol (MM KIT):
Each box contains 2 blister strips.
Mifton® strip: Each strip contains 1 tablet of Mifepristone INN 200 mg.
Misotol® strip: Each strip contains 4 tablets of Misoprostol USP 200 microgram each.
Mifton (Mifepristone): Mifepristone is a synthetic steroid with an anti-progestational activity that results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animals, species the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
Misotol (Misoprostol): Misoprostol is a synthetic analog of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.
DOSAGE AND ADMINISTRATION OF MM Kit:
MM Kit ® 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 Vacuum 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 the cheek & 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 ultrasonography scan that a complete termination of pregnancy has occurred.
MM KIT SIDE EFFECTS:
Mifton® (Mifepristone): The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR).
Common side effects: Nausea/Vomiting and Diarrhea.
Rare side effects: Pelvic pain, Fainting, Headache, Dizziness and Asthenia
Misotol® (Misoprostol): Gastro-intestinal side-effects like
Vomiting and constipation
Pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain and uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).
OVERDOSAGE OF MM KIT:
Mifton® (Mifepristone): No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.
Misotol® (Misoprostol): Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be an appropriate treatment for overdosage.
USE OF MM KIT IN PREGNANCY & LACTATION:
Mifton® (Mifepristone): is indicated for Menstrual Regulation (MR) (through 63 days of pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of fetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.
Mifton® (Mifepristone): It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breastmilk for a few days following administration of the medications.
Misotol® (Misoprostol): Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.
Use in Patients with Hepatic Impairment: Misotol® (Misoprostol): Patients with hepatic disease should receive decreased dose.
Use in Patients with Renal Impairment: Misotol® (Misoprostol): No routine dosage adjustment is recommended in older patients or patients with renal impairment but dosage may need to be reduced if the usual dose is not tolerated.
MM KIT DRUG INTERACTIONS:
Mifton® (Mifepristone): Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).
Misotol® (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.
The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & 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. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last 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.
Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or another prostaglandin, 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, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the administering physician.
MM KIT STORAGE INSTRUCTION:
Store in a cool and dry place, protected from light.
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