Table of Contents
- What is Mifepristone tablet?
- Uses of Mifepristone tablet
- How does Mifepristone tablet work?
- How to Take the Mifepristone tablet?
- Common Dosage for Mifepristone tablet
- When to Avoid Mifepristone tablet?
- Precautions While taking Mifepristone Tablet
- Side-Effects of Mifepristone tablet
- Drug Interactions to be Careful About
- Storage requirements for Mifepristone Tablet
- FAQs – 14 Important Questions Answered about Mifepristone tablet –
1What is Mifepristone tablet?
Mifepristone tablet is a synthetic anti-progestational steroidal tablet used for the termination of early pregnancy, used in a medical abortion process usually combined with Misoprostol. (>98% effective in first 49 days of pregnancy). Mifepristone tablet is also used to control BP in Cushing’s syndrome by blocking cortisol effects.
Mifepristone tablet Composition – inactive ingredients colloidal silica anhydrous and cornstarch, povidone, microcrystalline cellulose and magnesium stearate.
Manufactured By – Shreeji Pharma International
Prescription – not an OTC medicine, requires doctor’s prescription.
Form – most commonly used are tablets.
Price – Rs 1340 (Abo Pill -200mg, vol-4). Commonly bought with Misoprostol.
Expiry/Shelf Life – 48 months.
Type of Drug– anti-progestational steroid for medical termination of pregnancy.
Warning- Mifepristone tablet may cause loss of pregnancy. Pregnancy must be avoided while taking the medication and for one month after stopping the medication.
2Uses of Mifepristone tablet
Mifepristone, also known as RU-486 is prescribed for the following-
- Termination of pregnancy – Mifepristone tablet when used in combination with misoprostol can help in terminating an early pregnancy (seventy days or less since the start of last menstrual cycle)
- In Cushing’s syndrome – Also available as other product (korlym) used to control hyperglycemia (high blood sugar) in case of Cushing’s syndrome.
- Emergency Contraceptive – Sometimes used as a last resort even after seventy days have passed after last menstrual cycle as an emergency contraceptive.
- Treatment of tumor – Mifepristone tablet Helps in treating tumors of the brain.
- Treatment of endometriosis – Mifepristone tablet helps in treating the growth of uterus tissue outside of the uterus.
- Treatment of fibroids – Mifepristone tablet non-cancerous tumor growth in the uterus.
- Induction of labor – Mifepristone tablets may be used to help start the birth process in a pregnant woman.
3 How does Mifepristone tablet work?
- Blocks the action of progesterone, a hormone which is required to maintain pregnancy.
- Alters the endometrium or uterine lining and causes it to shed via bleeding through the vagina.
- In the case of pregnant women, Mifepristone tablet causes the cervix to soften up and produces uterine contractions during the time of childbirth.
4 How to Take the Mifepristone tablet?
Since this medication cannot be found in pharma stores, direct doctor supervision is required where ultrasound is done to make sure the pregnancy is less than 10 weeks or that it is not an ectopic pregnancy. ( outside the womb)
- Tablet 200mg – orally taken in combination with Misoprostol for contraception.
- Korlym tablet – orally taken as a cortisol receptor blocker.
5 Common Dosage for Mifepristone tablet
- Usual adult dose: for anti-gestational usage: day 1: 200mg Mifepristone tablet orally (single dose)
- Day 2: 800mcg buccal misoprostol after 24-48 hours of Mifepristone tablet intake.
- For Cushing’s syndrome: Adult dose: initial – 300mg orally/day
- Max dose: 1200mg/day (for otherwise healthy patient).
- Caution: high levels of mifepristone in blood is not advised.
- Usual pediatric dosage for abortion: day 1: 200mg Mifepristone tablet orally (single dose)
- Day 2: 800mcg buccal misoprostol after 24-48 hours of Mifepristone tablet intake.
Your doctor will decide the dosage based on the following conditions;
- To terminate the Presence of pregnancy which might be unwanted.
- High blood sugar levels in Cushing’s syndrome.
- The age group of the patient.
- Pre-existing diseases or conditions.
Q. What happens if I overdose on Mifepristone tablet?
The overdose of Mifepristone tablet can be a serious issue. It can cause the manifestation of toxicity in the body. It can produce abdominal pain, vomiting, diarrhea, and confusion along with anxiety.
Q. What happens if I miss a dose of Mifepristone tablet?
Mifepristone tablet are only available at a doctor’s clinic under medical supervision. Therefore there is no question of skipping the doses. The doctor only will provide the required medication in the correct dosage.
Q. What happens if I eat expired Mifepristone tablet?
Ans. Many medications can stay good months after expiry. However, we cannot know for sure. Probably, in most cases, it doesn’t portray a harmful effect but it doesn’t work either. Although, one should avoid expired medication at all costs as the outcome is unpredictable.
Q. What is the onset time of Mifepristone tablet?
Ans. It shows effect only after Misoprostol is taken after 24 to 48 hours. The onset of action will be 4 hours later of taking both the pills. Bleeding will take place through the vagina. The uterine lining starts to shed.
Q. Till When Does the Effect of Mifepristone tablet stay?
Ans. Bleeding starts after a few hours of taking the second pill and generally lasts for 3-5 hours. In some cases, women report heavy bleeding for up to 48 hours. Blood clots can pass till the passing of one week. However, only one course of medication is used to terminate a single one-time pregnancy.
6 When to Avoid Mifepristone tablet?
Use of Mifepristone tablet should be avoided in patients –
- with confirmed or suspected fertilized egg has implanted outside the uterus
- chronic adrenal failure,
- concurrent long-term corticosteroid therapy,
- history of allergy to mifepristone, misoprostol or other prostaglandin, bleeding disorders,
- liver or kidney impairment;
- ongoing pregnancy and lactation; IUD in place; undiagnosed uterus mass
- Mifepristone tablet should not be taken when trying to conceive a baby. Accidental intake for a pregnant mother may result in stunted growth processes for the baby.
7 Precautions While taking Mifepristone Tablet
- If a case of serious medical predetermined infection is present in the body then it is better not to take mifepristone at that time. it can cause fatal injection and bleeding
- An ultra-sonographic scan must be performed after 14 days of administration of mifepristone tablets in order to confirm the medical termination of pregnancy.
- Preventive measures must be taken to avoid the formation of RH negative antibodies in women with RH negative blood group to avoid any kind of complications
- mifepristone is to be used with caution in women younger than 35 years of age who have a history of smoking 10 cigarettes daily
- The doctor should check for ectopic pregnancy in some cases.
- The medication is only available by signing an agreement form for decisions taken due to the betterment of health. It is available under a medical supervisor.
- Mifepristone should not be used for hyperglycemia which is Unrelated to Cushing syndrome
- Low blood potassium level should be checked for and treated by prior methods before taking the medicine and adjusted accordingly for usage as Korlym.
- In case of adrenal insufficiency, the therapy should be disrupted and discontinued and further glucocorticoids should be provided
Warnings when using Mifepristone tablet-
To be used at the discretion of the doctor, only if required.
- One should take caution if she is on anticoagulant therapy. Women may experience unexpected vaginal bleeding.
- Use with caution if the patient has hemorrhagic disorders.
- Do not use the korlym brand of mifepristone tablet in order to terminate medical pregnancy.
- Serious and abnormal bleeding may occur in some cases which need medical attention as early as possible.
Please note: that there are a safer alternative to use than this and the risk becomes more than the potential benefits.
8 Side-Effects of Mifepristone tablet
Common side effects of mifepristone
- abdominal cramping
- abdominal pain
- Allergic reactions such as swelling of lips, face, throat.
- Back pain
- leg pain
- vaginal infection
- uterine bleeding
- viral infection
Are There Any Reported Allergic Reactions to mifepristone?
Signs of allergic reactions:
- Formation of hives and difficulty in breathing.
- Swelling of face occurs along with the swelling of lips, throat and tongue.
- A fever higher than 38 degree centigrade and lasting longer than 4 hours.
- A General ill feeling or very fast Heartbeat and a feeling of tiredness.
- Severe pelvic pain or no occurrence of bleeding after taking mifepristone.
What are the effects of mifepristone tablets on organs?
Mifepristone tablets cause a surge of hormonal imbalance in the body. By changing the progesterone levels, it can cause an interruption in pregnancy present in the uterus of the woman. Here is a list of possible disorders on the administration of mifepristone- please note that effects may vary from person to person, there is no way of confirming that a specific reaction may occur for sure in the body.
- Blood and lymphatic system disorders: anemia, allergic reactions like anaphylaxis, angioedema and hives and rashes.
- Cardiac system disorders: tachycardia, racing heart.
- Respiratory system disorders: shortness of breath, temporary decreased lung capacity.
- Vascular system disorders: fainting and loss of consciousness.
- Gastrointestinal system disorders: dyspepsia.
- muco skeletal system disorders: muscle pain and back pain.
- Reproductive system disorders: ruptures of ectopic pregnancy, hematometra and uterine rupture.
9Drug Interactions to be Careful About
One should follow the doctor’s instructions about any restrictions on food, beverages, or activity. Grapefruit and grapefruit juice can make it harder for the body to metabolize mifepristone tablets. Avoid the use of grapefruit products shortly before or after taking Mifeprex / mifepristone. We explore these in detail below.
1. Food Interactions with Mifepristone Tablet
Interacts with grape juice, so avoid it. (mild)
2. Medicines Interactions with Mifepristone
The usage of the following medications should be reported to the doctor as they interact with mifepristone tablets:
- John’s wort
- medication to treat hepatitis or HIV
- an antibiotic or antifungal medication
- heart or blood pressure medication
- seizure medication
- or tuberculosis medication
3. Effects of Mifepristone Tablet on Lab Tests
The patient has to report back to the clinic for the follow up checkup for successful termination of medical pregnancy by mifepristone usage. The patient is expected to communicate back within a week and immediately contact the doctor if any serious adverse reactions occur. Contact the doctor after 7 to 14 days.
However, the abortion procedure takes place in the doctors’ clinic and medical supervision is provided.
4. Mifepristone interactions with Pre-existing Conditions/Diseases
Anemic disorders, hemorrhagic disorders can cause complications.
- There are 6 disease interactions with mifepristone which include:
severe symptoms may occur in case of:
- organ transplant
- vaginal bleeding
- cardiovascular disease
- hepatic impairment
- long QT
- renal impairment
Q. Can I have a Mifepristone Tablet with alcohol?
Ans. Avoid taking the mifepristone with alcohol.
Q. Any particular food item to be avoided?
Ans. Food increases the blood levels of this medication. If one is only receiving one or two doses, they may take it without regard to meals. However, if one is in the receiving end of the medication for long-term treatment, they should take it with food at the same time every day to maintain consistent blood levels and effects.it is advised to Avoid consuming grapefruit or grapefruit juice during treatment, as it may increase blood levels of the medication to undesirable levels and increase the risk of side effects, including headache, dizziness, fatigue, nausea, vomiting, cramping, diarrhea, hypokalemia (low blood potassium), fluid retention, swelling, and high blood pressure.
Q. Can I have a Mifepristone Tablet when pregnant?
Ans. Intake of this medicine will result in the termination of pregnancy up to the given time period. Intake is suggested only in the case if pregnancy is unwanted.
Q. Can I have a Mifepristone Tablet when feeding a baby?
Ans. Sometimes metabolites from the medication may leech into the baby’s milk. Therefore it is advised for breastfeeding mothers to discard the milk processed during medical abortion procedure. It is safer not to provide the baby with breast milk while taking mifepristone.
Q. Can I drive after taking mifepristone?
Ans. Taking mifepristone does not affect orientation capabilities. There should not be extreme problems during driving. Anyways one maybe unwell to drive when she is getting adverse symptoms due to medicine intake.
10Storage requirements for Mifepristone Tablet
Mifepristone is stored at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.
11FAQs – 14 Important Questions Answered about Mifepristone tablet –
Q. What is Mifepristone Tablet?
Ans. Mifepristone, which is also known as RU-486, is a medicine used in combination with misoprostol to bring about abortion during pregnancy. This combination is more than 95% effective during the first 49 days of pregnancy period and it is also effective in the second trimester of pregnancy.
Q. What are the uses of Mifepristone Tablet?
Ans. Mifepristone is used in combination with misoprostol (Cytotec) to end an early pregnancy. When it has been 70 days or less since your last menstrual period began, it can be used. Mifepristone is in a class of medications called anti progestational steroidal medicine. It works by blocking the activity of progesterone, a hormone in the body which helthe ps in continuation of pregnancy. Mifepristone is also available as another product (Korlym), which is used to control hyperglycemia (high blood sugar) in people with a certain type of Cushing’s Syndrome in which the body makes too much of the hormone cortisol.
Q. What are the side effects of Mifepristone Tablet?
Ans. Mifepristone may cause more than a few side effects. Tell your doctor if any of these symptoms are severe or do not go away:
-vaginal bleeding or spotting
-vaginal burning, itching, or discharge
some side effects can be serious. However, all the side effects mentioned above may occur in slight proportions after the administration of mifepristone tablet.
Q. How effective is Mifepristone Tablet?
Ans. Mifepristone tablets, when combined with the usage of Misoprostol, can provide up to 98 % of success rate. However, the effects may be difficult to determine if mifepristone on tablets are taken on their own. Mifepristone in the form of korlym is effective for treating ectopic Cushing’s syndrome.
Q. How long does it take for Mifepristone Tablet to show results?
Ans. The anti-gestational activity starts after taking the medication by the oral route. (Followed by misoprostol which is Taken 24 to 48 hours after mifepristone) Bleeding may start after taking Misoprostol tablet as well. In some cases, women report the occurrence of bleeding up to 30 days. However, the abnormal amount of bleeding should be reported to medical authorities and should be brought to attention.
Q. Should Mifepristone be taken on an empty stomach?
Ans. It is recommended by the doctor to take mifepristone tablet in an empty stomach that is 2 hours before or 2 hours after a meal. One should wait at least 2 hours before taking the tablet after eating food.
Q. Does Mifepristone Tablet make you drowsy?
Ans. There have been reported signs of weakness and fatigue in case of taking mifepristone tablets. However, symptoms of weakness are common but only temporary.
Q. What should be the time gap between the intakes of 2 Mifepristone tablets?
Ans. Mifepristone tablets are generally prescribed by the medical practitioner onsite and administered in front of a paramedic in the doctor’s clinic. It is not required to take another mifepristone tablet back to back. Therefore a regiment of a time gap is followed between the intakes of two medicinal tablets of mifepristone. Administration of mifepristone is provided with caution. The doctor will understand best.
Q. Should I complete the whole cycle of the medicine even if cured?
Ans. The immediate effects of mifepristone tablet cannot be pre-determined and therefore, required tests are available to check the successful termination of pregnancy by the usage of these medications. However, doctor appointment is required after one week of usage of mifepristone tablet. If termination of pregnancy is not cited, other clinical procedures may have to be undertaken like surgical removal of pregnancy. However, such cases are not very common.
Q. Does Mifepristone Tablet effect my menstrual cycle?
Ans. Mifepristone tablets bring about a change in the menstrual cycle. Since the tablet produces an effect on the hormonal levels in the body and impacts progesterone levels in the blood it causes the menstrual cycle to change dates. Menstrual cycle may occur at an unexpected time.
Q. Is Mifepristone Tablet safe for children?
Ans. The usage of pediatric medication of mifepristone tablet is not recommended until and unless it is absolutely necessary.
Q. Are there any symptoms that I should consider before taking Mifepristone Tablet?
Ans. Symptoms to consider:
- a fever higher than 100.4 degrees F (38 degrees C) lasting longer than 4 hours;
- a general ill feeling or fast heartbeats; palpitation,
- Severe pelvic pain or tenderness; severe cramping,
- severe or ongoing nausea, vomiting, diarrhea,
- weakness; or
- No vaginal bleeding at all after taking Mifeprex.
Q. Is Mifepristone Tablet legal in India?
Ans. Yes, it is legal in India to use mifepristone but only with a doctor’s prescription.It is also known as a “non-invasive method of ending an unwanted pregnancy that women can use in a range of settings, and often in their own homes”. The two drugs approved for use in India are Mifepristone and Misoprostol for termination of pregnancy.
Q. Is there a generic variant for Mifepristone Tablet?
Ans. Mifepristone tablets are expensive medication with a minimum cost of Rs 400 and above. Mifepristone is a synthetic steroid. The Mifeprex brand of mifepristone is indicated for the medical termination of intrauterine pregnancy through 70 days gestation in combination with misoprostol. But scientific research has shown that alone or in combination with methotrexate, misoprostol is an efficacious alternative to mifepristone for the medical termination of pregnancy.
Disclaimer – The information provided above is to the best of our research and knowledge. However, you are recommended to consult a physician before consuming the drug.