Mifeprex (Mifepristone/Misoprostol)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Mifeprex (mifepristone) is used with misoprostol to medically terminate intrauterine pregnancy up to 70 days gestation.
Mifeprex is available in 200 mg oral tablets.
Directions
Take Mifeprex as prescribed by your doctor.
Recommended dosing: Mifeprex 200 mg by mouth on Day 1, then 800 mcg buccal misoprostol 24-48 hours after Mifeprex; patients must follow up with their physician to confirm the completion of pregnancy termination.
Store Mifeprex at 25°C (77°F) and out of reach of children.
For additional usage instructions, refer to the Mifeprex medication guide that comes with your prescription.
Do not hesitate to reach out to your doctor or pharmacist with questions or concerns.
Ingredients
The active ingredient in Mifeprex is mifepristone.
Inactive ingredients include colloidal silica anhydrous, corn starch, povidone, microcrystalline cellulose, and magnesium stearate.
Contraindications
Mifeprex should not be administered to patients with any of the following:
- Confirmed or suspected ectopic pregnancy or adnexal mass that is undiagnosed
- Chronic adrenal failure
- Receiving long-term corticosteroid therapy
- Have had an allergy to mifepristone, misoprostol, or other prostaglandins
- Hemorrhagic disorders or are taking blood thinners (anticoagulants)
- Inherited porphyria
- Intrauterine device in place
Cautions
- Mifeprex contains the following FDA Boxed Warning:
- Infections and bleeding that are serious and sometimes fatal occur very rarely after spontaneous, surgical, and medical abortions, including following Mifeprex use.
- Atypical Presentation of Infection. Patients with serious bacterial infections and sepsis can present in the absence of fever, bacteremia, or significant findings on pelvic examination. A high index of suspicion is necessary to rule out serious infection and sepsis.
- Bleeding. Heavy bleeding that is prolonged may be a sign of incomplete abortion or other complications; medical or surgical intervention may be promptly needed.
- Mifeprex is only available through a restricted program called the Mifepristone REMS Program.
- Before prescribing Mifeprex, the patient should be informed 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 fainting, or if they experience abdominal pain or discomfort or general discomfort for more than 24 hours after taking misoprostol.
- Before you receive Mifeprex, tell your doctor:
- About all the medications you take, including prescription and over-the-counter medications, supplements, vitamins, and herbals
- About your allergies
- About your current health problems and past medical history
- If you are pregnant or breastfeeding
- Ectopic pregnancy should be ruled out before receiving Mifeprex.
- Prevention against rhesus immunization is required as is for surgical abortion.
Side Effects
Nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness are the most common Mifeprex side effects; however, other side effects may also occur.
Contact your doctor right away if you have side effects that bother you or persist.
Ask your doctor about Mifeprex.
Reference
- Mifeprex. New York, NY: Danco Laboratories, LLC; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 12630
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