PREGNO KIT – A combi pack of Mifepristone and Misoprostol

Composition:                      Each pack contains

1. One tablet Mifepristone

                  Each uncoated tablet contains Mifepristone 200 mg

1. 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

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.