Femikit 200 mg+200 mcg (Tablet)

Indications

• Early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation

Composition

• Each box contains 2 blister strips
• One strip contains 1 tablet of Mifepristone INN 200 mg
• Another strip contains 4 tablets of Misoprostol USP 200 microgram each.

Pharmacology

• Mifepristone is a synthetic steroid with anti-progestational activity
• Mifepristone sensitizes the myometrium to the contraction-inducing activity of prostaglandins
• Misoprostol is a synthetic analogue of prostaglandin E1 causing myometrial contraction by interacting with specific receptors
• Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents

Dosage & Administration

• Mifepristone administration: One tablet of Mifepristone (200 mg)
• Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually
• Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone

Interaction

• Possible inhibition of Mifepristone metabolism by Ketoconazole, Itraconazole, Erythromycin, and grapefruit juice

Contraindications

• History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin
• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
• IUD in place
• Chronic adrenal failure
• Haemorrhagic disorders or concurrent anticoagulant therapy
• Inherited porphyria

Side Effects

• Nausea, vomiting, diarrhea, pelvic pain, fainting, headache, dizziness, asthenia

Pregnancy & Lactation

• Risk of foetal malformation resulting from the treatment if pregnancy continues after treatment
• Mifepristone effects on infants through human milk are unknown, consult doctor for breast-feeding
• Misoprostol should not be administered to nursing mothers

Precautions & Warnings

• Combination of Mifepristone & Misoprostol should not be given to anyone else
• Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins
• Surgical termination is recommended in cases of treatment failures

Use in Special Populations

• Patients with hepatic disease should receive a decreased dose of Misoprostol
• No routine dosage adjustment is recommended for Misoprostol in older patients or patients with renal impairment

Overdose Effects

• No serious adverse reactions reported with Mifepristone in tolerance studies
• Clinical signs of overdose with Misoprostol include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension or bradycardia

Therapeutic Class

• Drugs acting on the Uterus
• Prostaglandin analogues

Storage Conditions

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

Related Brands

• Veri Kit 200 mg+200 mcg (Tablet) - veritas-pharmaceuticals-ltd