Femikit 200 mg+200 mcg (Tablet)

(1+4) tablet kit: ৳ 300.00

Medicine Details

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

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