Prescription Required: Registered Medical Practitioner's prescription is required to purchase this product.

Human

Femikit®

Tablet

200 mg + 200 mcg

GENERIC NAMEMifepristone + Misoprostol

MANUFACTURED BYEskayef Pharmaceuticals Ltd.

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Available Pack Sizes:1 Size

Maximum Retail Price (MRP):

Quantity

৳ 60.00/ 1 strip (1 tablet Mifeprist + 4 tablets Misoprost)

16263

Composition

Femikit: Each box contains 1 tablet of Mifeprist (Mifepristone INN 200 mg/ tablet) & 4 tablets o Misoprost (Misoprostol Dispersion USP equivalent to Misoprost 200 mcg/ Tablet) in a strip.

Description

Mirepstone™: Mirepstone is a synthetic anti-progestogen which antagonizes the action of progesterone by competing with its binding to its receptor. Based on extensive studies performed on animals for the oral doses, the compound is found to inhibit endogenous or exogenous progestogens function and Menstrual Regulation (MR) happens. The loss of progesterone activity during pregnancy causes a series of intrauterine and cervical changes, breast-feeding termination or pregnancy.

Misoprostol™: Misoprostol is a progestational analogue (Prostaglandin E1) that causes uterine contraction completing medical abortion. It binds to particular receptors of myometallic cells to induce heavy cravings in the myometrium, which result in tissue expulsion. Contractions occur due to the modifications in calcium concentrations. Binding of Misoprostol to prostaglandin receptors causes cervical ripening with softening and dilation of the cervix.

Indications

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

Dosage & Administration

Femikit® can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.

Day (First visit): Mirepstone administration:

One tablet of Mirepstone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a hospital, medical office or clinic.

Day (Second visit): Misoprostol administration:

24-48 hours after ingesting of Mirepstone tablet, the patient takes 4 tablets of 200 micrograms (400 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheek & gum or under tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patients may need medication for the post-contraindicated 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-termination examination:

Patients may return to the clinic, medical office or hospital within 10 to 14 days after the administration of Misoprostol. This visit is very important to confirm by clinical examination or ultra-sangomyxogram 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 Vacuum Aspiration) is recommended to manage Menstrual Regulation (MR) termination of pregnancy failures.

Interaction

Mifeprist : No interaction studies have been performed. On the basis of this drug's metabolism by CYP3A4, i is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, Rifampicin, Dexamethasone anticonvulsants (Phenytoin, Phenobarbital, Carbamazepine) may induce Mifepristone metabolism (lowering serum levels of Mifepristone). Misoprost : 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.

Contraindications

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other 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 anticoagulan 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.

Side Effects

*Mirepstone®:** The treatment is designed to induce the vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects are nausea, vomiting and diarrhea. Pelvic pain, faim, headache, dizziness and asthenia occurred rarely.

*Misoprostol®:** Gastro-intestinal side effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, pain due to uterine contractions, postpartum bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or laparoscopy/hysterectomy).

*Overdose**.

*Mirepstone®:** No serious adverse reactions were reported in tolerance studies in healthy non-pregnant female and healthy male-subjects where Mirepstone was administered in single doses greater than threshold of 600mg for Menstrual Regulation (MR). If a patient injects a massive overdose, she should be observed closely for signs of adrenal failure.

*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. It is not known if misoprostol or Misoprostol is adequate. However, because Misoprostol is marketed as a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdose.

Pregnancy & Lactation

Pregnancy:

Mirepstone®: Mirepstone is indicated for use in the termination of pregnancy (through 63 days pregnancy) and has no other accepted indication for use during pregnancy. Patients who have.

Precautions & Warnings

Mifepristone and Misoprostol combination should not be given to anyone else. Administration must be under the supervision of a qualified physician. The combination of Mifepristone & Misoprostol has been prescribed for the patients specific condition, it may not be the correct treatment for another patient, and may be dangerous to the other women 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 (Manual Vacuum Aspiration) is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Storage Conditions

Store at or below 30°C temperature. Keep away from light and wet place. Keep out of reach of children.

Femikit® • 1 strip (1 tablet Mifeprist + 4 tablets Misoprost)

৳ 60.00