Cytomis Kit

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

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal 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.

Misoprostol: Misoprostol is a synthetic analogue 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.

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).

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.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days 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 foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• 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 breast milk for a few days following administration of the medications.
• 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.

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 foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Drugs acting on the Uterus, Prostaglandin analogues

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.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, 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 the appropriate treatment for overdosage.

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