Trade name: MIFEPREX® + Cytotec®
Generic names: mifepristone + misoprostol
Indication and Usage: FDA has approved MIFEPREX® (mifepristone) to end a pregnancy through ten weeks gestation, however Cytotec® (misoprostol) is used off-label and is not FDA approved for this indication.
Ingredients | MIFEPREX® (mifepristone) contains: 200 mg of mifepristone (a synthetic steroid with
antiprogestational effects), colloidal silica anhydrous, corn starch, povidone, microcrystalline cellulose, and magnesium stearate.
Cytotec® (misoprostol) contains: 100 mcg or 200 mcg of misoprostol (a synthetic prostaglandin E1
analog), hydrogenated castor oil, hydroxypropyl methylcellulose, microcrystalline cellulose, and sodium starch glycolate.
Manufacturer-listed adverse reactions | MIFEPREX® (mifepristone) can cause: Atypical presentation of infection including serious bacterial infections and sepsis, Prolonged heavy bleeding due to incomplete abortion or other complication requiring prompt medical or surgical intervention, Serious bacterial infection including fatal septic shock, Fever of 100.4°F or higher, Severe abdominal pain, Pelvic tenderness, 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. Prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Allergic reaction (including anaphylaxis, angioedema, hives, rash, itching), Pain, Anemia, Loss of consciousness, Nausea, Weakness, Vomiting, Headache, Diarrhea, Post-abortal infection (including endometritis, endomyometritis, parametritis, pelvic infection, pelvic inflammatory disease, and salpingitis), Anxiety, Tachycardia (including racing pulse, heart palpitations, heart pounding), Syncope (fainting), Hypotension (including orthostatic), Light-headedness, Shortness of breath, Dyspepsia (indigestion), Back/leg pain, Uterine rupture, Ruptured ectopic pregnancy, Hematometra (retention of blood in the uterus), and Leukorrhea (thick, whitish, yellowish or greenish vaginal discharge).
Cytotec® (misoprostol) can cause: Aches/pains, Asthenia (weakness), Fatigue, Fever, Rigors, Weight changes, Rash, Dermatitis, Alopecia (hair loss), Pallor, Breast/chest pain, Abnormal taste/vision, Conjunctivitis, Syncope (fainting), Deafness, Tinnitus (ringing ears), Earache, Upper respiratory tract infection, Bronchitis, Bronchospasm, Dyspnea (shortness of breath), Pneumonia, Epistaxis (nosebleed), Edema, Diaphoresis, Reflux, Hypotension/hypertension, Arrhythmia, Phlebitis, Increased cardiac enzymes, GI bleeding, GI inflammation/infection, Rectal disorder, Abnormal hepatobiliary function, Gingivitis, Dysphagia (difficulty swallowing), Amylase increase, Anaphylaxis, Glycosuria (sugar in the urine), Gout, Increased nitrogen, Increased alkaline phosphatase, Polyuria (large urine production), Dysuria (painful urination), Hematuria (blood in urine), Urinary tract infection, Abnormal differential, Neuropathy, Neurosis, Confusion, Arthralgia (joint stiffness), Myalgia (muscle pain), Muscle cramps, Stiffness, Back pain, Anemia, Anxiety, Change in appetite, Depression, Drowsiness, Dizziness, Impotence, Loss of libido, Sweating increase, Purpura, ESR increased, and Thrombocytopenia
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