Abortion Pills Kit: Mifepristone 200 mg + Misoprostol 800 mcg for Medical Termination of Pregnancy

Product description

1. Introduction
2. Evolution of Medical Abortion
3. Discovery of Prostaglandins
4. Discovery of Mifepristone
5. Approval of Medical Abortion
6. Dosing and Timing of Abortion Pills Kit
7. Counseling
8. Confirmation of Pregnancy Termination
9. Efficacy of these Regimens
10. Birth Control
11. Contraindications
12. Caution is Required When
13. Special Situations
14. Continuing Pregnancy After Administration (Failure of Medication Abortion)
15. FAQ’s

1. Introduction

Abortion under unsafe conditions is a major global health issue. In 2002 and 2003, for instance, India had 6.4 million abortions, of which 56%, or 3.6 million, were unsafe (Abortion Assessment Project I, 2004). In addition, roughly 46 million abortions are done annually worldwide due to labor induction.

Abortions induced by Mifepristone and prostaglandin were legalized for the first time in 1988. Since the launch of this approach, research has concentrated chiefly on enhancing its effectiveness and establishing the appropriate kind, dosage, and route of administration of the prostaglandin analog. The optimal dosage of Mifepristone to cause an abortion has been the subject of several investigations.

The relatively high price of Mifepristone has been a significant factor in the decision to lower the recommended dose. However, with the information in this brochure, you may better comprehend the problems and developments surrounding Medical Abortion.

Our online pharmacy has other abortion pill kits in stock that contain identical doses of Mifepristone and Misoprostol: MTP kit, and Combipack Mifepristone + Misoprostol, Mifepristone + Misoprostol Kit.

2. Transformation of Abortion Medicine

Abortion medicines are nothing new. Many drugs, pills, decoction, and other substances like papaya, abrus precatorius, etc., have been used by women throughout history to induce abortion, as documented in historical texts. But the vast majority of these medicines have either failed to work as an abortifacient or have been harmful to the health of the women using them.

As a result, the public now believes that pharmaceutical abortion is ineffective. This is a completely false belief. Thus, counselors should stress the safety and effectiveness of today’s medications.

3. Discovery of Prostaglandins

This was a crucial stage in refining our techniques to make them safer. Prostaglandin was injected directly into the amniotic fluid in the first trials. Nonetheless, these procedures worked well for causing abortions only in the second trimester. Rapidly, a vaginally applied prostaglandin was created that proved effective in the first trimester of pregnancy. Unfortunately, available prostaglandin analogs have significant limitations, including pain and gastrointestinal side effects, preventing widespread usage.

Myocardial infarction was linked to Sulprostone because it caused coronary spasms, and gemeprost was replaced with the safer drug- Misoprostol because of its many drawbacks (instability at room temperature, difficulty in storage and transportation, high cost, and restricted availability).

Misoprostol

Synthetic prostaglandin E1 is called Misoprostol. Misoprostol causes the cervix to efface (loosen) and the uterus to contract. Furthermore, it prevents stomach acid from being produced.

Mode of Action of Misoprostol

Misoprostol triggers contractions in the uterine lining by binding to receptors expressed on the surface of myometrial cells. This interaction brings on changes in calcium concentrations that first set off a muscle contraction. In addition, by interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, expulsing the uterine contents.

Pharmacokinetics of Oral and Vaginal Misoprostol

Misoprostol’s therapeutic action results from its wide absorption and rapid metabolism to the free acid, the biologically active form.

After oral treatment, the plasma Misoprostol levels climbed swiftly, peaked at 30 minutes, decreased quickly, and remained low after that.

Contrarily, following vaginal treatment, plasma concentrations climbed slowly, peaking at 70–80 minutes, then progressively decreasing, with measurable levels still present 6 hours later. Misoprostol stimulates the uterus for a more extended period when administered vaginally than when administered orally.

However, a greater dosage of Misoprostol was needed when administered alone for Medical Abortion, resulting in significant gastrointestinal side effects such as cramping, nausea, vomiting, and diarrhea.

4. The Turning Point (Discovery of Mifepristone)

What Role Does Mifepristone Play in the Process?

Inhibiting progesterone’s function, like Mifepristone does, ends the pregnancy. Mifepristone’s anti-progestational effect results from competitive interaction with progesterone at progesterone-receptor sites. Since it blocks the effects of natural and synthetic progesterone, it may be used to hasten the end of a pregnancy.

Studies have revealed that Mifepristone, at doses of 1 mg/kg or more, blocks the effects of progesterone on the endometrium and the myometrium in women. Furthermore, Mifepristone causes down-regulation of progesterone-dependent genes, decidual necrosis, and separation of the products of conception by inhibiting transcription through the receptor-Mifepristone complex.

However, it became apparent that Mifepristone, administered alone, had a maximum efficiency of 80%, which was not enough to be utilized as an abortifacient medicine in clinical practice.

The last significant advancement occurred when it was shown that Mifepristone improved the sensitivity of the pregnant myometrium to prostaglandins, allowing for a lower dosage of prostaglandin. As a result, a combination therapy consisting of Mifepristone and Misoprostol was developed.

Mifepristone is used to terminate the pregnancy, while Misoprostol is used to get rid of the baby.

5. Approval of Medical Abortion

Medical Abortion was first approved in France in 1988, followed by approvals in the UK (1991) and Sweden (1992). Finally, Medical Abortion was approved in India in 2002.

6. Dosing and Timing for Abortion Pills Kit

The MTP Act allows Medication Abortion up to 49 days of gestation. However, this is conditional to the provider following the MTP act, including filling Form C and the MTP register.
Day 1: Mifepristone 200 mg orally. Injection of Anti-D to Rh-negative patient
Day 3: Misoprostol 400 mcg vaginally or orally
Day 14: Follow-up visit to assess for completion of abortion, preferably clinically or by ultrasonography if indicated.

The Drug Controller Authority of India has approved a combipack of Mifepristone and misoprostol for use up to 77 days from LMP.
Regime — 49 to 77 days
Day 1: Mifepristone 200 mg orally. Injection of Anti-D to Rh-negative patient
Day 3: Misoprostol 800 mcg vaginal preferred/sublingual/buccal
Day 14: Follow-up visit for clinical assessment
As per the MTP Act, Medical methods for termination of pregnancy not exceeding seven weeks may be prescribed by a registered medical practitioner (as defined in the act) as prescribed under Section 2 (d). Rule 3, having access to a place approved by the Government under Section 4 (b) & Rule 5 of MTP Rules. RMP should display a certificate to this effect from the owner of the approved place.

Besides the regimen mentioned above, the following regimens are also practiced.

1. US FDA approved-regimen 2000
The regimen is approved for up to 49 days of gestation.
Day 1: Mifepristone 600 mg orally
Day 3: Misoprostol 400 mcg orally
Day 14: Follow-up visit to assess for completion of abortion clinically, by ultrasonography, or by documenting a significant decrease in serum beta-hCG levels.
Surgical termination is recommended if a viable pregnancy is detected at this time by ultrasonography because the pregnancy may continue, and there is a risk of fetal malformation.

2. Regimen recommended by Royal College Of Obstetrics and Gynecology (RCOG), World Health Organization (WHO)
The regimen is recommended for up to 77 days of gestation.
Day 1: Mifepristone 200 mg orally
Day 3: Misoprostol 800 mcg vaginally
For women at 49–77 days of gestation, if abortion has not occurred 4 hours after administration of Misoprostol, the second dose of Misoprostol 400 mcg may be administered vaginally or orally.
Day 14: Follow-up visit to assess for completion of abortion clinically, by ultrasonography, or by documenting a significant decrease in serum beta-hCG levels.

Surgical termination is recommended if a viable pregnancy is detected at follow-up because the pregnancy may continue, and there is a risk of fetal malformation.

7. Counseling

Counseling might have a significant role in how patients see the Abortion Pills Kit. Therefore, counseling services must meet clients’ needs while maintaining their privacy. All the patient’s concerns should be answered, but the following discussion topics should be included at a minimum.

Bleeding from the vaginal area may persist for 10–14 days. It often manifests as extended, heavy menstruation. The patient should notify the doctor right away if she notices that she is bleeding excessively or passing clots.

• The patient may sometimes see the ejection of the fetus or embryo. Tell her that they typically seem like a rosy mass. She needs reassurance that what she is experiencing is typical of the process.
• The process typically requires three visits.
• Abortion surgery may be necessary if the medical route fails (this is very uncommon), there are retained products of conception, or there is heavy bleeding.

Preventing an unintended pregnancy after an abortion is possible with the use of contraception.

8. Verification of Aborted Pregnancy

Schedule a follow-up appointment for 14 days following Mifepristone treatment to confirm a successful pregnancy termination and evaluate the severity of any bleeding. Having vaginal bleeding does not prove a pregnancy has ended. Clinical evaluation of an ultrasonographic scan may confirm the termination. However, if the bleeding stops after therapy, it is likely unsuccessful. Therefore, surgical termination should be used to deal with failed Medical Abortions.

It cannot be overstated how unnecessary ultrasonography is to the process of having an abortion with medicine. Instead, it is a tool that the doctor should use when necessary.

9. Efficacy of these Regimens

After two weeks of using Mifepristone and Misoprostol, heartbeats are considered an actual medication failure. Unfortunately, only around one percent of females experience this, and the procedure must be performed medically.

Complete abortion was achieved in 92% of patients in research where 600 mg of Mifepristone was followed by 400 mcg of Misoprostol orally for women desiring to terminate pregnancies up to 77 days of gestation, with 8% of patients requiring a Surgical Abortion. In the latter case, incomplete abortion (5% of cases) and ongoing pregnancy (1% of cases) were cited as justifications for surgical termination of pregnancy. Only 0.6% of patients actively sought an intervention, whereas 2% had a medical need.

Complete abortion was achieved in 97.5% of patients in a case study of 2,000 women with pregnancies up to 77 days of gestation who took 200 mg of Mifepristone, followed by 800 g of Misoprostol. Incomplete abortion (1.4%), missed abortion (0.4%), and continued pregnancy (0.6%) all contributed to the 2.5% of patients who needed surgical evacuation.

10. Birth Control

Post-abortion contraceptive counseling is just as crucial as the actual technique used. Pregnancy is possible for the lady immediately, even before her next period. Therefore, the patient must promptly implement a method of contraception.

After it’s decided to end a pregnancy, it’s time to start using contraception. After that point, any type of birth control is acceptable.

11. Contraindications for Abortion Pills Kit

Abortion is one of the safest medical operations, and abortion with medication is even safer. Medical Abortion is legal in all but a handful of cases. In this category are items such as:

1. Allergic response to one of the medications used before.
2. Genetic porphyria.
3. Chronic adrenal insufficiency.
4. Ectopic pregnancy, either confirmed or suspected.

12. Caution is Required When

1. When using Corticosteroids for an Extended period (including those with severe, uncontrolled asthma).
2. Her condition causes her to bleed excessively.
3. Her anemia is dreadful.
4. She was born with a cardiac defect or has a family history of heart disease (e.g., hypertension and smoking).

13. Exceptional Circumstances

Age

Medical Abortion should not be ruled out just because of a patient’s age, whether they are teenagers or far into their 35s.

Anemia

This need not be regarded as a contraindication. However, anemia detected at the time of abortion should be treated. In addition, average blood loss in Medical Abortion may be more than that in Surgical Abortion, and the incidence of heavy bleeding may be higher.

Breastfeeding

Mifepristone may end up in breast milk. Almost immediately after administration, very few levels of Misoprostol pass into breast milk; nevertheless, its potential impact on the newborn is unknown. It has been suggested that, in the event of oral delivery, Misoprostol should be administered shortly after a feed, with the subsequent meal occurring 4 hours later.

Misoprostol levels remain elevated for a more extended period after vaginal administration; hence, the meal should be given more than 6 hours after the medication was given. Unfortunately, the current information does not provide a firm suggestion on optimal time.

14. Maintaining a Pregnancy After Abortion Pills Kit Administration (Failure of Medication Abortion)

Mifepristone

Mifepristone has just one authorized application during pregnancy: to terminate a pregnancy (up to 77 days along).

Patients with a continuing pregnancy who were at risk of fetal deformity at the time of their previous visit usually gave birth. When Medical Abortion fails, it is best to terminate the pregnancy surgically.

Misoprostol

Misoprostol and other prostaglandins have been linked in the literature to potential teratogenic consequences in humans. Exposure during the first trimester has been linked to various birth problems, including skull deformations, face malformations, limb deformities, and delays in growth and psychomotor development, to name a few.

Diseases of the thyroid or the pancreas that need insulin

Women with these conditions should feel safe seeking a Medical Abortion since there is no evidence to suggest that this procedure increases their risk of experiencing complications. There is evidence that Mifepristone affects insulin sensitivity in vitro, but whether this translates to changes in glucose and insulin levels in the body has to be seen.

Pregnancies in Multiples (Current Gestation)

Multiple pregnancies do not increase the failure rate of Medical Abortion, nor do they need a modified dosing schedule.

Obesity

Overweight women do not have a higher Medical Abortion failure risk, and there is no evidence to suggest that a particular dose regimen is necessary for them.

Bronchial Asthma

A combination of Mifepristone and Misoprostol is effective.

Previous Cesarean Section

According to one research, preceding cesarean sections do not compromise the safety or effectiveness of early Medical Abortions.

Smoking

Cigarette smoking is not associated with an increased risk of complications during a Medical Abortion. However, cardiovascular risk factors, including smoking, should be addressed when determining a woman’s eligibility for Medical Abortion.

Congenital and Acquired Uterine Malformations; Prior Cervical Surgery

There is no proof that any of these conditions could be considered warning signs.

15. FAQ’s

Following is a list of some of the problems that require fixing. Indeed, there are more inquiries than can be included here, but we do hope the following is of some use:

1. Is it essential to know how long it takes to give the Prostaglandin after Mifepristone?

After Mifepristone priming, the uterus is most susceptible to prostaglandin between 36 and 48; hence, the therapeutic dosage may be lowered to the bare minimum within this window. Recent research, however, has shown that when Mifepristone is used with 800 mcg of vaginally administered Misoprostol, the interval may be decreased to 24 hours or increased to 72 hours without loss of effectiveness. In this case, the recommended time between doses of Misoprostol (400 mcg) is 36–48 hours.

Researching more periods is ongoing.

2. To what extent should women undergoing a Medical Abortion access pain medication?

Abortion itself is painful, and prostaglandin has unpleasant side effects moreover. As the gestational sac/embryo is being released from the uterus, the pain is most likely to be experienced in the few hours after the injection of the prostaglandin.

All women who desire it should have easy access to sufficient analgesia from their healthcare professional during a Medical Abortion. The most often used dosages are 500–1,000 mg of Paracetamol or 200 mg of an NSAID like Ibuprofen for pain and inflammation relief. Supplementing one of the methods above with codeine 30–40 mg is an option for patients with severe pain (see “Pain in medical abortion”).

3. Do the drugs used in Medical Abortion have any unwanted side effects?

The abortion method is intended to cause bleeding and discomfort in the uterus, which are prerequisites to a successful abortion. It’s predicted that most women who take Mifepristone with Misoprostol will have some negative response to the medication, and many of them will have more than one. Here are some of them:

1. Adverse digestive system effects include bloating, gas, heartburn, indigestion, nausea, vomiting, and constipation.
2. Shivering.
3. Hyperthermia.
4. Dizziness.
5. Contraction pain in the uterus.
6. Blood loss in the genitalia at an alarming degree.
7. Shock.
8. Discomfort in the genital area.
9. Rupture of the uterus (resulting in the need for a hysterectomy, a salpingo-oophorectomy, or both).

4. Is Mifepristone and Misoprostol Overdosage Possible?

Mifepristone

In intolerance, tests revealed no severe side events when single doses of Mifepristone larger than three times the recommended amount for termination of pregnancy (600 mg) were delivered to healthy non-pregnant women. However, a patient who takes a large dosage must be constantly monitored for adrenal failure.

In mice, rats, and dogs, an oral dosage of Mifepristone greater than 1,000 mg/kg is the acute fatal dose.

Misoprostol

Sedation, tremors, convulsions, difficulty breathing, stomach discomfort, diarrhea, fever, palpitations, hypotension, or bradycardia are all possible clinical indications of overdose. Therapeutic interventions that alleviate symptoms are recommended. The realizability of Misoprostol acid has not been established. Misoprostol is processed similarly to fatty acids. Therefore, dialysis is probably not a suitable option for treating overdose.

5. Should I Take Any Special Precautions Before, During, or After a Medical Abortion?

All non-sensitized RhD-negative women should be given an injection of anti-D IgG (250 IU before 20 weeks of gestation and 500 IU after that) into the deltoid muscle within 72 hours after having an abortion, whether it was performed surgically or medically.

Curettage equipment and IV fluids should be on hand in an emergency or at least easily obtained.

It is essential to rule out potential drug interactions by ensuring the patient is not frail, pregnant, or suffering from any other conditions that might prevent them from receiving the medication.

Tell the patient when they should report symptoms (such as discomfort, bleeding, or difficulty passing products) and what they should report.

Prepare the patient for an unexpected situation by instructing them on what to do and whom to contact.