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Pregno Kit

Generic Name

 A combi pack of Mifepristone and Misoprostol                       

Therapeutic class

Mifepristone: Anti-ulcer

Misoprostol: Endocrine Metabolic Agent

Pharmacological Class

Mifepristone: Antiprogestational steroid

Misoprostol: Prostaglandin Analogue

Composition

Each pack contains:

a.    One tablet Mifepristone

Each uncoated tablet contains Mifepristone 200 mg.

b.    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

What is Pregno-Kit?  

Pregno-Kit, available as combination pack of one 200 mg mifepristone tablet and four tablets each containing misoprostol 200 mcg, offers women an early-pregnancy abortion option that doesn’t involve surgery.

In what conditions Pregno-Kit can be used?

 Pregno-Kit is used for medical termination of pregnancy.

How does Pregno-Kit work?    

Pregno-Kit use is a two-step method:

 Pregnancy needs a hormone called progesterone to grow normally. Pregno blocks your body’s own progesterone, stopping the pregnancy from growing. Also, as progesterone is blocked, the uterine lining begins to shed, the cervix begins to soften and bleeding may occur.

Mistol, either taken right away or up to 48 hours later causes cramping and bleeding to empty your uterus. It’s like having a really heavy, crampy period, and the process is very similar to an early miscarriage.

How to take Pregno-Kit?    

The recommended regimen for medical abortion:

 

Women with undesired pregnancies ≤63 day’s gestation may be offered the option of the following regimen:

  • Pregno 200 mg orally, followed by Mistol 800 mcg vaginally administered once at any point 1–3 days later.
  • Administering Mistol 6–8 hours after Pregno appears to be equally effective.

Women with pregnancies of ≤49 day’s gestation who prefer the oral route of administration:

  • Mistol may be administered as an 800 mcg oral dose 2 days after Pregno.
  • Mistol 800 mcg buccally 2 days after Pregno is another option for women who prefer to avoid vaginal administration, but they should be counseled about increased side-effects.

                                                        

What do you need to know before you take Pregno-Kit?

Choosing a medical or surgical procedure for an abortion will depend on your medical history, how many weeks pregnant you are, what options are available where you live, and your personal preferences.

Tell your doctor if you have:

                                                   

Do not hesitate to provide information to your healthcare provider about the underlying health conditions that you have and also about other medicines that you are currently taking.

What to expect after taking complete dose of Pregno-Kit?

·         Most people feel fine after taking the first tablet. Some will have nausea, and fewer will experience bleeding.

  • Upon taking Mistol 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.
  • Within 4 hours of taking the second medicine (mistol), many women have vaginal bleeding and cramping, and the pregnancy is terminated.Most pregnancies end within the first 24 hours after the mistol dose. If not, then typically a second dose of mistol is given.

 

Signs of complication:

Call your healthcare provider immediately if you have any of these symptoms after an abortion:

  • Severe bleeding: Both medical and surgical abortions usually cause bleeding that is different from a normal menstrual period. Severe bleeding can mean:
    • Passing clots that are bigger than a golf ball, lasting 2 or more hours.
    • Soaking more than 2 large pads in an hour, for 2 hours in a row.
    • Bleeding heavily for 12 hours in a row.
  • Signs of infection in your whole body, such as headache, muscle aches, dizziness, or a general feeling of illness. Severe infection is possible without fever.
  • Severe pain in the abdomen that is not relieved by pain medicine, rest, or heat.
  • Hot flushes or a fever of 100.4°F (38°C) or higher that lasts longer than 4 hours
  • Vomiting lasting more than 4 to 6 hours.
  • Sudden abdominal swelling or rapid heart rate.
  • Vaginal discharge that has increased in amount or smells bad.
  • Pain, swelling, or redness in the genital area.

Call your healthcare provider for an appointment if you have had any of these symptoms after a recent abortion:

  • Bleeding (not spotting) for longer than 2 weeks.
  • New, unexplained symptoms that may be caused by medicines used in your treatment.
  • No menstrual period within 6 weeks after the procedure.
  • Signs and symptoms of depression. Hormonal changes after a pregnancy can cause depression that requires treatment.

 

Warnings and Precautions:

·       Avoid alcohol and aspirin while using Pregno and Mistol for a medical abortion.

·       Serious bacterial infection or STDs should be identified.

·       If you don’t have any bleeding within 24 hours after taking the second medicine, call healthcare provider.

·       Vaginal bleeding does not confirm termination; so, clinical examination or ultra-sonographic scan should be done after 2 weeks of taking Pregno-Kit.

·        If a medical abortion is not successful, a surgical abortion is then done to complete the process because Mistol can cause fetal abnormalities.

 

What special dietary instructions do you need to follow?

  • Avoid the use of grapefruit products shortly before or after taking Pregno.
  • Follow your healthcare provider’s instructions about any other restrictions on food, beverages, or activity.                                      

 Can Pregno-Kit be taken during pregnancy?

Pregno- Kit is contraindicated in case of wanted pregnancies.       

Can lactating mothers consume Pregno-Kit?  

The medicines in Pregno-Kit can sometimes pass into breastmilk. But it’s usually in small amounts that shouldn’t affect a baby. You can talk with your healthcare provider if you’re breastfeeding, and they’ll help you figure out what’s best for you and your baby.

 

Possible Side effects:                    

Most of the side effects are due to Mistol and includes:

·       Heavy bleeding

·       Nausea

·       Headache

·       Vomiting

·       Heavy cramping

·         Diarrhea

Side effects may increase as the length of pregnancy increases and in women having their first pregnancy.

Does the Pregno-Kit have long-term side effects?

Unless there’s a rare and serious complication that’s not treated, there’s no risk to your future pregnancies or to your overall health. Serious, long-term emotional problems after an abortion are rare, and about as uncommon as they are after giving birth. They are more likely to happen in people who have to end a pregnancy because of health reasons, people who do not have support around their decision to have an abortion, or people who have a history of mental health problems.

 

Patient Information:

·       Do not have sexual intercourse for at least 1 week, or longer, as advised by your healthcare provider.

·       There is a chance that you can get pregnant very quickly after your abortion, so talk with your healthcare provider about birth control to find a method that’s right for you. Contraception can be initiated as soon as termination has been confirmed.

·       Your next regular period may come at any time within 6 weeks after the abortion. Be sure to contact your doctor if you do not have a period within 6 weeks.

·       It’s normal to bleed and spot off and on for several weeks after your abortion. You can use pads, tampons, or a menstrual cup, whatever’s the most comfortable for you. But your healthcare provider may recommend you use pads for a few days after the abortion so you can track how much you’re bleeding.

Pharmacodynamics:

Mifepristone is a synthetic steroid with antiprogestational effects indicated for the medical termination of intrauterine pregnancy. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit and monkey), the compound inhibits the activity of endogenous or exogenous progesterone.

Misoprostol is a prostaglandin E1 analog used to manage miscarriages and used alone or in combination with mifepristone for first trimester abortions.  It binds to smooth muscle cells in the uterine lining to increase the strength and frequency of contractions as well as degrade collagen and reduce cervical tone.

An oral dose of misoprostol has an 8 minute onset of action and a duration of action of approximately 2 hours, a sublingual dose has an 11 minute onset of action and a duration of action of approximately 3 hours, a vaginal dose has a 20 minute onset of action and a duration of action of approximately 4 hours, and a rectal dose has a 100 minute onset of action and a duration of action of approximately 4 hours.

 

 Pharmacokinetics:

Absorption:

Mifepristone: Peak Plasma Concentration is achieved in 2-8 hr and the absolute bioavailability is 69%.

Misoprostol: Rapid absorption 

 

Protein binding:

Mifepristone: Greater than 99%

Misoprostol: Approximately 85%              

                                                                                                         

Metabolism:

Mifepristone: Hepatic (Extensively metabolized by CYP3A4)

Misoprostol: Hepatic                 

                                                            

Route of elimination:

Mifepristone: 90% of the dose is excreted as metabolites in feces.

Misoprostol: Urine

 

Half-life:

Mifepristone: The half life of elimination is about 20 hour following single dose of administration.

Misoprostol: The half life of elimination is 20-40 minutes.

 

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.