Mifepristone 200 mg Tablet, 1 tablet
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Mifepristone (Korlym) is used to treat hyperglycemia (high blood sugar) in people with a certain type of Cushing's syndrome in which the body makes too much cortisol (a hormone) and who have failed surgery or cannot have surgery to treat this condition. Mifepristone is in a class of medications called cortisol receptor blockers. It works by blocking the activity of cortisol. Mifepristone is also available as another product (Mifeprex) that is used alone or in combination with another medication to end an early pregnancy. This monograph only gives information about mifepristone (Korlym) used to...
Read the full MedlinePlus article ↗- Great question — this one confuses a lot of people. Mifepristone isn't a standard diabetes drug. It's only used when Cushing's syndrome is what's causing your blood sugar to be hig...
- Why is mifepristone being prescribed for my blood sugar if I already know I have diabetes?
- This is really important. Mifepristone blocks progesterone, which is the hormone your body needs to sustain a pregnancy — so if you became pregnant while taking it, the pregnancy w...
- I'm a woman of childbearing age. What do I need to know about birth control while on this?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mifepristone 200 mg 43393-0001-06 | GenBioPro, | 6 tablets | — | AB | FDA listed | — |
| Mifepristone 200 mgthis 84670-0014-01 | Evita | 1 tablet | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84670-0014-01 You're viewing this | 1 TABLET in 1 BLISTER PACK (84670-014-01) | 2026-07-29 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristone Tablets, 200 mg use. No causal relationship between the use of Mifepristone Tablets, 200 mg and misoprostol and these events has been established. Atypical Presentation of Infection.
Patients with serious bacterial infections (e.g., Clostridium sordellii ) and sepsis can present without fever, bacteremia, or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis [see Warnings and Precautions ( 5.1 )] Bleeding.
Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding [see Warnings and Precautions ( 5.2 )] . Because of the risks of serious complications described above, Mifepristone Tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Mifepristone REMS Program [see Warnings and Precautions ( 5.3 )] .
Before prescribing mifepristone tablets, inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol. WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING See full prescribing information for complete boxed warning.
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristone Tablets, 200 mg use . Atypical Presentation of Infection. Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination.
A high index of suspicion is needed to rule out serious infection and sepsis. ( 5.1 ) Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed.
( 5.2 ) Mifepristone Tablets, 200 mg is only available through a restricted program called the Mifepristone REMS Program ( 5.3 ). Before prescribing Mifepristone Tablets, 200 mg, inform the patient about these risks. Ensure the patient knows whom to call and what to do if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort or general malaise for more than 24 hours after taking misoprostol.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Mifepristone Tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Mifepristone Tablets, 200 mg is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 200 mg mifepristone tablet on Day 1, followed 24 to 48 hours after mifepristone tablet dosing by 800 mcg buccal misoprostol. ( 2.1 ) Instruct the patient what to do if significant adverse reactions occur. ( 2.2 ) Follow-up is needed to confirm complete termination of pregnancy. ( 2.3 )
2.1Dosing Regimen For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period. The duration of pregnancy may be determined from menstrual history and clinical examination. Assess the pregnancy by ultrasonographic scan if the duration of pregnancy is uncertain or if ectopic pregnancy is suspected.
Remove any intrauterine device (“IUD”) before treatment with Mifepristone Tablets, 200 mg begins [see Contraindications (4)] . The dosing regimen for Mifepristone Tablets, 200 mg and misoprostol is: Mifepristone Tablets, 200 mg orally + misoprostol 800 mcg buccally • Day One : Mifepristone Tablets, 200 mg Administration One 200 mg tablets of Mifepristone is taken in a single oral dose. • Day Two or Three : Misoprostol Administration (minimum 24-hour interval between, Mifepristone Tablet, 200 mg and misoprostol) Four 200 mcg tablets (total dose 800 mcg) of misoprostol are taken by the buccal route.
Tell the patient to place two 200 mcg misoprostol tablets in each cheek pouch (the area between the cheek and gums) for 30 minutes and then swallow any remnants with water or another liquid (see Figure 1 ). Patients taking Mifepristone Tablets, 200 mg must take misoprostol within 24 to 48 hours after taking Mifepristone Tablets. The effectiveness of the regimen may be lower if misoprostol is administered less than 24 hours or more than 48 hours after mifepristone administration.
Because most women will expel the pregnancy within 2 to 24 hours of taking misoprostol [see Clinical Studies ( 14 )], discuss with the patient an appropriate location for them to be when taking the misoprostol, taking into account that expulsion could begin within 2 hours of administration. figure-1
2.2Patient Management Following Misoprostol Administration During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms [see Adverse Reactions ( 6 )] . Give the patient: Instructions on what to do if significant discomfort, excessive vaginal bleeding or other adverse reactions occur A phone number to call if the patient has questions following the administration of the misoprostol The name and phone number of the healthcare provider who will be handling emergencies.
2.3Post-treatment Assessment: Day 7 to 14 Patients should follow-up with their healthcare provider approximately 7 to 14 days after the administration of Mifepristone Tablets, 200 mg. This assessment is very important to confirm that complete termination of pregnancy has occurred and to evaluate the degree of bleeding. Termination can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan.
Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion. The existence of debris in the uterus (e.g., if seen on ultrasonography) following the treatment procedure will not necessarily require surgery for its removal. Patients should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days.
Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of women may experience some type of bleeding for more than 30 days. Persistence of heavy or moderate vaginal bleeding at the time of follow-up, however, could indicate an incomplete abortion.
If complete expulsion has not occurred, but the pregnancy is not ongoing, patients may be treated with another dose of misoprostol 800 mcg buccally. There have been rare reports of uterine rupture in women who took Mifepristone Tablets, 200 mg and misoprostol, in…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets containing 200 mg of mifepristone each, supplied as 1 tablet on one blister card. Mifepristone tablets are light yellow coloured, round, biconvex tablets debossed with “CC12” on one side and plain on other side and free from physical defects. Tablets containing 200 mg of mifepristone each, supplied as 1 tablet on one blister card
⛔ Contraindications ▾
4 CONTRAINDICATIONS Administration of Mifepristone Tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) [ see Warnings and Precautions ( 5.4 )] Chronic adrenal failure (risk of acute adrenal insufficiency) Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency) History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported [ see Adverse Reactions ( 6.2 )]) Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) Inherited porphyrias (risk of worsening or of precipitation of attacks) Use of Mifepristone Tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination).
If the IUD is removed, Mifepristone Tablets, 200 mg may be used. Confirmed/suspected ectopic pregnancy or undiagnosed adnexal mass ( 4 ) Chronic adrenal failure ( 4 ) Concurrent long-term corticosteroid therapy ( 4 ) History of allergy to mifepristone, misoprostol, or other prostaglandins ( 4 ) Hemorrhagic disorders or concurrent anticoagulant therapy ( 4 ) Inherited porphyria ( 4 ) Intrauterine device (IUD) in place ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Exclude before treatment. ( 5.4 ) Rhesus immunization: Prevention needed as for surgical abortion. ( 5.5 )
5.1Infection and Sepsis As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifepristone Tablets, 200 mg [see Boxed Warning ] . Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii ) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone Tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established.
Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.
5.2Uterine Bleeding Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion [see Boxed Warning ] .
Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more.
In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased. Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patient who bleed heavily. Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions.
Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.
5.3Mifepristone REMS Program Mifepristone Tablets, 200 mg is available only through a restricted program under a REMS called the Mifepristone REMS Program, because of the risks of serious complications [see Warnings and Precautions ( 5.1 , 5.2 )]. Notable requirements of the Mifepristone REMS Program include the following: Prescribers must be certified with the program by completing the Prescriber Agreement Form. Patients must sign a Patient Agreement Form.
Mifepristone Tablets, 200 mg must only be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers. Further information is available at 1-866-718-0098.
5.4Ectopic Pregnancy Mifepristone Tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone tablets is…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Infection and sepsis [ see Warnings and Precautions ( 5.1 )] Uterine bleeding [ see Warnings and Precautions ( 5.2 )] Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Evita Solutions LLC at 1-866-718-0098 or [email protected] or www.medicalabortionpill.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Information presented on common adverse reactions relies solely on data from U.S. studies, because rates reported in non-U.S. studies were markedly lower and are not likely generalizable to the U.S. population. In three U.S. clinical studies totaling 1,248 women through 70 days gestation who used mifepristone 200 mg orally followed 24 to 48 hours later by misoprostol 800 mcg buccally, women reported adverse reactions in diaries and in interviews at the follow-up visit.
These studies enrolled generally healthy women of reproductive age without contraindications to mifepristone or misoprostol use according to the Mifepristone Tablets, 200 mg product label.Gestational age was assessed prior to study enrollment using the date of the woman's last menstrual period, clinical evaluation, and/or ultrasound examination. About 85% of patients report at least one adverse reaction following administration of Mifepristone Tablets, 200 mg and misoprostol, and many can be expected to report more than one such reaction.
The most commonly reported adverse reactions (>15%) were nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness (see Table 1). The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age. Abdominal pain/cramping is expected in all medical abortion patients and its incidence is not reported in clinical studies.
Treatment with Mifepristone Tablets, 200 mg and misoprostol is designed to induce uterine bleeding and cramping to cause termination of an intrauterine pregnancy. Uterine bleeding and cramping are expected consequences of the action of Mifepristone Tablets, 200 mg and misoprostol as used in the treatment procedure. Most patients can expect bleeding more heavily than they do during a heavy menstrual period [see Warnings and Precautions ( 5.2 )] .
Table 1 lists the adverse reactions reported in U.S. clinical studies with incidence >15% of women. Table 1 Adverse Reactions Reported in Women Following Administration of Mifepristone (oral) and Misoprostol (buccal) in U.S. Clinical Studies Adverse Reaction # U.S. studies Number of Evaluable Women Range of frequency (%) Upper Gestational Age of Studies Reporting Outcome Nausea 3 1,248 51-75% 70 days Weakness 2 630 55-58% 63 days Fever/chills 1 414 48% 63 days Vomiting 3 1,248 37-48% 70 days Headache 2 630 41-44% 63 days Diarrhea 3 1,248 18-43% 70 days Dizziness 2 630 39-41% 63 days One study provided gestational-age stratified adverse reaction rates for women who were 57 to 63 and 64 to 70 days; there was little difference in frequency of the reported common adverse reactions by gestational age.
Information on serious adverse reactions was reported in six U.S. and four non-U.S. clinical studies, totaling 30,966 women through 70 days gestation who used mifepristone 200 mg orally followed 24 to 48 hours later by misoprostol 800 mcg buccally. Serious adverse reaction rates were similar between U.S. and non-U.S. studies, so rates from both U.S. and non-U.S. studies are presented. In the U.S. studies, one studied women through 56 days gestation, four th…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP3A4 inducers can lower mifepristone concentrations. ( 7.1 ) CYP3A4 inhibitors can increase mifepristone concentrations. Use with caution. ( 7.2 ) CYP3A4 substrate concentrations can be increased. Caution with coadministration of substrates with narrow therapeutic margin. ( 7.3 )
7.1Drugs that May Reduce Mifepristone Tablets, 200 mg Exposure (Effect of CYP 3A4 Inducers on Mifepristone Tablets, 200 mg) CYP450 3A4 is primarily responsible for the metabolism of mifepristone. CYP3A4 inducers such as rifampin, dexamethasone, St. John's Wort, and certain anticonvulsants (such as phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum concentrations of mifepristone).
Whether this action has an impact on the efficacy of the dose regimen is unknown. Refer to the follow-up assessment [see Dosage and Administration ( 2.3 )] to verify that treatment has been successful.
7.2Drugs that May Increase Mifepristone Tablets, 200 mg Exposure (Effect of CYP 3A4 Inhibitors on Mifepristone Tablets, 200 mg) Although specific drug or food interactions with mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that ketoconazole, itraconazole erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum concentrations of mifepristone). Mifepristone Tablets, 200 mg should be used with caution in patients currently or recently treated with CYP 3A4 inhibitors.
7.3Effects of Mifepristone Tablets, 200 mg on Other Drugs (Effect of Mifepristone Tablets, 200 mg on CYP 3A4 Substrates) Based on in vitro inhibition information, coadministration of mifepristone may lead to an increase in serum concentrations of drugs that are CYP 3A4 substrates. Due to the slow elimination of mifepristone from the body, such interaction may be observed for a prolonged period after its administration. Therefore, caution should be exercised when mifepristone is administered with drugs that are CYP 3A4 substrates and have a narrow therapeutic range.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Risk of fetal malformations in ongoing pregnancy if not terminated is unknown. ( 8.1 )
8.1Pregnancy Risk Summary Mifepristone Tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Risks to pregnant women are discussed throughout the labeling. Refer to misoprostol labeling for risks to pregnant patients with the use of misoprostol.
The risk of adverse developmental outcomes with a continued pregnancy after a failed pregnancy termination with Mifepristone Tablets, 200 mg in a regimen with misoprostol is unknown; however, the process of a failed pregnancy termination could disrupt normal embryo-fetal development and result in adverse developmental effects. Birth defects have been reported with a continued pregnancy after a failed pregnancy termination with Mifepristone Tablets, 200 mg in a regimen with misoprostol. In animal reproduction studies, increased fetal losses were observed in mice, rats, and rabbits and skull deformities were observed in rabbits with administration of mifepristone at doses lower than the human exposure level based on body surface area.
Data Animal Data In teratology studies in mice, rats and rabbits at doses of 0.25 to 4.0mg/kg (less than 1/100 to approximately 1/3 the human exposure based on body surface area), because of the antiprogestational activity of mifepristone, fetal losses were much higher than in control animals. Skull deformities were detected in rabbit studies at approximately 1/6 the human exposure, although no teratogenic effects of mifepristone have been observed to date in rats or mice. These deformities were most likely due to the mechanical effects of uterine contractions resulting from inhibition of progesterone action.
8.2Lactation Mifepristone Tablets, 200 mg is present in human milk. Limited data demonstrate undetectable to low levels of the drug in human milk with the relative (weight-adjusted) infant dose 0.5% or less as compared to maternal dosing. There is no information on the effects of Mifepristone Tablets, 200 mg in a regimen with misoprostol in a breastfed infant or on milk production.
Refer to misoprostol labeling for lactation information with the use of misoprostol. The developmental and health benefits of breast-feeding should be considered along with any potential adverse effects on the breast-fed child from Mifepristone Tablets, 200 mg in a regimen with misoprostol.
8.4Pediatric Use Safety and efficacy of Mifepristone Tablets, 200 mg have been established in pregnant females. Data from a clinical study of Mifepristone Tablets, 200 mg that included a subset of 322 females under age 17 demonstrated a safety and efficacy profile similar to that observed in adults.
🆘 Overdosage ▾
10 OVERDOSAGE No serious adverse reactions were reported in tolerance studies in healthy non-pregnant female and healthy male subjects where mifepristone was administered in single doses greater than 1,800 mg (ninefold the recommended dose for medical abortion). If a patient ingests a massive overdose, the patient should be observed closely for signs of adrenal failure.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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, resulting in effects on the uterus and cervix that, when combined with misoprostol, result in termination of an intrauterine pregnancy. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
12.2Pharmacodynamics Use of Mifepristone Tablets, 200 mg in a regimen with misoprostol disrupts pregnancy by causing decidual necrosis, myometrial contractions, and cervical softening, leading to the expulsion of the products of conception. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. Antiglucocorticoid and antiandrogenic activity: Mifepristone also exhibits antiglucocorticoid and weak antiandrogenic activity.
The activity of the glucocorticoid dexamethasone in rats was inhibited following doses of 10 to 25 mg/kg of mifepristone. Doses of 4.5 mg/kg or greater in human beings resulted in a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol. Antiandrogenic activity was observed in rats following repeated administration of doses from 10 to 100 mg/kg.
12.3Pharmacokinetics Mifepristone is rapidly absorbed after oral ingestion with non-linear pharmacokinetics for C max after single oral doses of 200 mg and 600 mg in healthy subjects. Absorption The absolute bioavailability of a 200 mg mifepristone oral dose in females of childbearing age is 69%. Following oral administration of a single dose of 600 mg, mifepristone is rapidly absorbed, with a peak plasma concentration of 1.98 ± 1.0 mg/L occurring approximately 90 minutes after ingestion.
Following oral administration of a single dose of 200 mg in healthy men (n=8), mean C max was 1.77 ± 0.7 mg/L occurring approximately 45 minutes after ingestion. Mean AUC 0-∞ was 25.8 ± 6.2 mg*hr/L. Distribution Mifepristone is 98% bound to plasma proteins, albumin, and α 1 -acid glycoprotein.
Binding to the latter protein is saturable, and the drug displays nonlinear kinetics with respect to plasma concentration and clearance. Elimination Following a distribution phase, elimination of mifepristone is slow at first (50% eliminated between 12 and 72 hours) and then becomes more rapid with a terminal elimination half-life of 18 hours. Metabolism Metabolism of mifepristone is primarily via pathways involving N-demethylation and terminal hydroxylation of the 17-propynyl chain.
In vitro studies have shown that CYP450 3A4 is primarily responsible for the metabolism. The three major metabolites identified in humans are: (1) RU 42 633, the most widely found in plasma, is the N-monodemethylated metabolite; (2) RU 42 848, which results from the loss of two methyl groups from the 4-dimethylaminophenyl in position 11ß; and (3) RU 42 698, which results from terminal hydroxylation of the 17-propynyl chain. Excretion By 11 days after a 600 mg dose of tritiated compound, 83% of the drug has been accounted for by the feces and 9% by the urine.
Serum concentrations are undetectable by 11 days. Specific Populations The effects of age, hepatic disease and renal disease on the safety, efficacy and pharmacokinetics of mifepristone have not been investigated.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Mifepristone Tablets, 200 mg is only available through a restricted program called the Mifepristone REMS Program [see Warnings and Precautions ( 5.3 )]. Mifepristone Tablets, 200 mg is supplied as light yellow coloured, round, biconvex tablets debossed with “CC12” on one side and plain on other side and free from physical defects. Each tablet contains 200 mg of mifepristone.
One tablet is individually blistered on one blister card that is packaged in an individual package (National Drug Code 84670-014-01). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Mifepristone tablets each contain 200 mg of mifepristone, a synthetic steroid with antiprogestational effects. The tablets are light yellow coloured, round, biconvex, debossed with “CC12” on one side, plain on other side and free from physical defects and are intended for oral administration only. The tablets include the inactive ingredients colloidal silicon dioxide, maize starch, povidone, microcrystalline cellulose, and magnesium stearate.
Mifepristone is a substituted 19-nor steroid compound chemically designated as 11ß-[ p - (Dimethylamino) phenyl]-17ß-hydroxy- 17-(1-propynyl) estra-4,9-dien-3-one. Its empirical formula is C 29 H 35 NO 2 . Its structural formula is: The compound is a yellow powder with a molecular weight of 429.6 and a melting point of 192 to 196°C.
It is very soluble in methanol, chloroform and acetone and poorly soluble in water, hexane and isopropyl ether. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide), included with each package of Mifepristone Tablets, 200 mg. Additional copies of the Medication Guide are available by contacting Evita Solutions LLC at 1-866-718-0098 or www.medicalabortionpill.com Serious Infections and Bleeding Inform the patient that uterine bleeding and uterine cramping will occur [see Warnings and Precautions ( 5.2 )] . Advise the patient that serious and sometimes fatal infections and bleeding can occur very rarely [see Warnings and Precautions ( 5.1 , 5.2 )] .
Mifepristone Tablets, 200 mg are only available through a restricted program called the Mifepristone REMS Program [see Warnings and Precautions ( 5.3 )] . Under the Mifepristone REMS Program: Patients must sign a Patient Agreement Form. Mifepristone Tablets, 200 mg is only dispensed by or under the supervision of certified prescribers or by certified pharmacies on prescriptions issued by certified prescribers.
Provider Contacts and Actions in Case of Complications Ensure that the patient knows whom to call and what to do, including going to an emergency room if none of the provided contacts are reachable, or if the patient experiences complications including prolonged heavy bleeding, severe abdominal pain, or sustained fever [see Boxed Warning ]. Compliance with Treatment Schedule and Follow-up Assessment Advise the patient that it is necessary to complete the treatment schedule; including a follow-up assessment approximately 7 to 14 days after taking mifepristone tablets, 200 mg [see Dosage and Administration ( 2.3 )] .
Explain that: prolonged heavy vaginal bleeding is not proof of a complete abortion, if the treatment fails and the pregnancy continues, the risk of fetal malformation is unknown, it is recommended that ongoing pregnancy be managed by surgical termination [ see Dosage and Administration ( 2.3 )] . Advise the patient whether you will provide such care or will refer them to another provider. Subsequent Fertility Inform the patient that another pregnancy can occur following medical abortion and before resumption of normal menses.
Inform the patient that contraception can be initiated as soon as pregnancy expulsion has been confirmed, or before resuming sexual intercourse. Manufactured for: Evita Solutions LLC P.O. Box 20055 Roanoke, VA 24018 1-866-718-0098 www.medicalabortionpill.com UK/Drugs/12/UA/SC/P-2009 Made in India Revised: 11/2025
💬 Medication Guide ▾
MEDICATION GUIDE Mifepristone (MIF-eh-pris-tone) Tablets, 200 mg for oral use Read this information carefully before taking Mifepristone Tablets, 200 mg and misoprostol. It will help you understand how the treatment works. This Medication Guide does not take the place of talking with your healthcare provider.
What is the most important information I should know about Mifepristone Tablets, 200 mg? What symptoms should I be concerned with? Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth.
Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifepristone Tablets, 200 mg and misoprostol caused these deaths.
If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider. You can write down your healthcare provider's telephone number here _______________________. Be sure to contact your healthcare provider promptly if you have any of the following: Heavy Bleeding.
Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C). Abdominal Pain or “Feeling Sick.” If you have abdominal pain or discomfort, or you are “feeling sick,” including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your healthcare provider without delay.
These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb). Fever . In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your healthcare provider right away.
Fever may be a symptom of a serious infection or another problem. If you cannot reach your healthcare provider, go to the nearest hospital emergency room. What to do if you are still pregnant after Mifepristone Tablets, 200 mg with misoprostol treatment.
If you are still pregnant, your healthcare provider will talk with you about a surgical procedure to end your pregnancy. In many cases, this surgical procedure can be done in the office/clinic. The chance of birth defects if the pregnancy is not ended is unknown.
Talk with your healthcare provider. Before you take Mifepristone Tablets, 200 mg you should read this Medication Guide and you and your healthcare provider should discuss the benefits and risks of your using Mifepristone Tablets, 200 mg. What is Mifepristone Tablets, 200 mg?
Mifepristone Tablets, 200 mg is used in a regimen with another prescription medicine called misoprostol, to end an early pregnancy. Early pregnancy means it is 70 days (10 weeks) or less since your last menstrual period began. Mifepristone Tablets, 200 mg is not approved for ending pregnancies that are further along.
Mifepristone Tablets, 200 mg blocks a hormone needed for your pregnancy to continue. When you use Mifepristone Tablets, 200 mg on Day 1, you also need to take another medicine called misoprostol 24 to 48 hours after you take Mifepristone Tablets, 200 mg to cause the pregnancy to be passed from your uterus. The pregnancy is likely to be passed from your uterus within 2 to 24 hours after taking Mifepristone Tablets, 200 mg and misoprostol.
When the pregnancy is passed from the uterus, you will have bleeding and cramping that will likely be heavier than your usual period. About 2 to 7 out of 100 women taking Mifepristone Tablets, 200 mg will need a surgical procedure because the pre…