Each box contains 2 blister strips.
Mifeston strip: 1 strip contains 1 tablet of Mifepristone INN 200 mg.
Cytomis 200 Buccal Strip: 1 strip contains 4 tablet of Misoprostol BP 200 microgram.
Misoprostol is a synthetic prostaglandin E1 analogue that has uterine contractibility properties. Misoprostol interact with specific receptors on myometrial cells causes myometrial contraction thus soften & open the cervix resulting in the expulsion of uterine contents.
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 of Mifepristone tablet, the patient takes 4 tablets of 200 microgram (800 micrograms) of Misoprostol buccally. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheek & gum). She should wait for 30 minutes.
During the period immediately following the administration of Misoprostol, the patients may need medication for cramps or gestational symptoms. The patient should be given a phone number to call if she has questions following the administration of Misoprostol.
Day 10 to 14
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 (Manual vaccum Aspiration) is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.
Misoprostol: Gastro-intestinal side effects like diarrhea, 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).
Mifepristone is indicated for use in the termination of pregnancy (through 63 days pregnancy) and has no other approved indication for use during pregnancy.
Mifepristone: It is not known whether Mifepristone is excreted in 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 health care provider 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 acid is excreted in 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 children
Safety and effectiveness in pediatric patients have not been established.
Based on invitro inhibition information, co-administration of Mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates.
Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.
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 anti-platelet effects of therapeutic doses of aspirin.
Misoprostol: Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension, or bradycardia. Symptomsshould be treated with supportive therapy. It is not known if misoprostol acid is dialyzable.However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.