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PREGNO KIT A combi pack of Mifepristone and Misoprostol Composition:       Each pack contain
  • One tablet Mifepristone
     Each uncoated tablet contains Mifepristone 200mcg
  • Four tablets Misoprostol
     Each uncoated tablet contains Misoprostol 200 mcg Pregnancy Category:        X Presentation:   Available in the pack size as 4 + 1 tablets X 1 blister
Description
FDA and WHO approved combination pill for medical termination of pregnancy. Mifepristone is the progesterone receptor antagonist. Misoprostol is a synthetic prostaglandin E1 (PGE1) analog.
How does Pregno Kit work?
  • Mifepristone blocks the hormone progesterone needed to maintain the pregnancy.
  • As progesterone is blocked, the uterine lining begins to shed, the cervix begins to soften and bleeding may occur.
  • After addition of Misoprostol, the uterus begin to contract expelling out the contents
  • Finally leading to the termination of pregnancy.
Indications
  • Medical termination of pregnancy
The recommended regimen for medical abortion
Women with undesired pregnancies ≤63 day’s gestation may be offered the option of the following regimen:
  • Mifepristone 200 mg orally, followed by Misoprostol 800 µg vaginally administered once at any point 1–3 days later.
  • Administering Misoprostol 6–8 hours after mifepristone appears to be equally effective.
Women with pregnancies of ≤49 day’s gestation who prefer the oral route of administration,
  • Misoprostol may be administered as a 400-µg oral dose 2 days after mifepristone.
  • Misoprostol 800 µg sublingually 2 days after mifepristone is another option for women who prefer to avoid vaginal administration, but they should be counseled about increased side-effects.
Confirmation of Termination
A follow up exam should be scheduled for confirmation of termination after 2 weeks of taking Mifepristone.
What to expect??
  • One may bleed after taking Mifepristone; some women may bleed lightly while other may bleed heavily.
  • Upon taking Misoprostol tablets, cramping, bleeding and clotting may begin as soon as 20 minutes.
  • Within the next 6-8 hours most women suffer miscarriage.
  • Cramping may come in waves with decreasing and increasing intensities.
Adverse Effects
Most of the side effects are due to misoprostol and includes:
  • Heavy bleeding
  • Nausea
  • Headache
  • Vomiting
  • Heavy cramping
  • Diarrhea
Contraindications
PREGNO KIT is contraindicated in the following populations and situations:
  • In ectopic pregnancy*
  • Intrauterine device (IUD) in place
  • Chronic adrenal failure
  • Concurrent long term corticosteroid therapy
  • Hemorrhagic disorders* or concurrent anticoagulant therapy
  • Inherited porphyria*
  • Allergic to mifepristone, misoprostol or PG analogue.
Warnings and Precaution
  • Vaginal bleedings may last for 9-16 days. Severe heavy bleeding may require medical attention.
  • Serious bacterial infection or STDs should be identified.
  • Vaginal bleeding do not confirm termination so clinical examination or ultra-sonographic scan should be done after 2 weeks of taking pills.
  • After taking pill if termination didn’t occur then one should not bear child as there are chances of teratogenic effects.
Drug Interactions
  • Ketoconazole, itraconazole, erythromycin and grapefruit juice may inhibit mifepristone and misoprostol metabolism.
  • Similarly, rifampicin, dexamethasone, St. John’s Worts, phenytoin, phenobarbital and carbamazepine may induce mifepristone metabolism.
Patient Information
  • Following termination one can be pregnant.
  • Contraception can be initiated as soon as termination has been confirmed.
  • It is unknown whether mifepristone and misoprostol are secreted in the milk or not, so one should consult a doctor if to discard the milk for some days.
*Terminologies: Ectopic Pregnancy: Also known as tubal pregnancy, is a complication of pregnancy in which the embryo attaches outside the uterus. Hemorrhagic Disorders: Spontaneous or near spontaneous bleeding caused by a defect in clotting mechanisms or another abnormality causing a structural flaw in the blood vessels. Inherited porphyria: Refers to a group of disorders that result from a buildup of natural chemicals that produce porphyrin in your body.