Mifepristone
Generic Name: mifepristone
Brand Names:
Mifepristone
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.
Overview
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.
Uses
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
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 ) 2.1 Dosing 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)] .
Side Effects
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.
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 ) 7.1 Drugs 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).
Warnings
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. 5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Exclude before treatment. ( 5.4 ) Rhesus immunization: Prevention needed as for surgical abortion. ( 5.5 ) 5.1 Infection 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. 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...
Storage
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.
Frequently Asked Questions
What is Mifepristone used for?▼
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 )
What are the side effects of Mifepristone?▼
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.
What are the important warnings for Mifepristone?▼
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. 5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Exclude before treatment. ( 5.4 ) Rhesus immunization: Prevention needed as for surgical abortion. ( 5.5 ) 5.1 Infection 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. 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...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.