Monograph Details
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Ob/Gyn
> Miscellaneous Ob/Gyn conditions
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MIFEPREX |
| Manufacturer |
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Danco Laboratories |
| Legal Classification |
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PP |
| Pharmacological Class |
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Abortifacient. |
| Generic Name |
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Mifepristone 200mg; tabs. |
| Indications |
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Termination of intrauterine pregnancy through day 49 of pregnancy. |
| Children |
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Not recommended. |
| Adults |
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Physician must sign and return Prescriber's Agreement; patient must read and sign Patient Agreement and read Medication Guide. Day 1: mifepristone 600mg as a single oral dose. Day 3: misoprostol 400micrograms as a single oral dose unless abortion confirmed. Day 14: confirm that complete termination of pregnancy has occurred by clinical exam or ultrasonographic scan. |
| Contraindications |
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Ectopic pregnancy or undiagnosed adnexal mass. IUD in place. Chronic adrenal failure. Prostaglandin allergy. Hemorrhagic disorders. Inherited porphyrias. Concurrent long-term corticosteroid therapy. Anticoagulants. Patients unable to understand effects of treatment or to comply with regimen, or those without adequate access to appropriate medical facilities. |
| Precautions |
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To be given only by or under the supervision of physicians who have signed and returned the Prescriber's Agreement; are able to assess gestational age of embryo and diagnose ectopic pregnancy; who have access to facilities for emergency treatment of incomplete abortion, severe bleeding, or resuscitation; and who meet requirements for storage, dose tracking, etc. Do surgical termination if mifepristone and misoprostol fail. Procedures to prevent rhesus immunization must be used. Hemostatic disorders. Hypocoagulability. Severe anemia. Chronic medical conditions (eg, cardiovascular, hypertensive, hepatic, respiratory, or renal disease). Women >35yrs of age who smoke ≥10 cigarettes per day. Pregnancy: treatment failure may result in fetal malformation. Nursing mothers: see literature (consider suspending breastfeeding for a few days after therapy). |
| Interactions |
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See Contraindications. May potentiate CYP3A4 substrates. May be potentiated by ketoconazole, itraconazole, erythromycin, grapefruit juice. May be antagonized by rifampin, dexamethasone, St. John's wort, phenytoin, phenobarbital, carbamazepine. |
| Adverse Reactions |
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Vaginal bleeding (may be prolonged or severe), cramping, GI upset, headache, dizziness, fatigue, back pain, fever, vaginitis, rigors, insomnia, asthenia, leg pain, anxiety, anemia, leukorrhea, syncope; rare: serious bacterial infections, sepsis (may be fatal). |
| Extra Text |
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Note: Report serious adverse events by calling (877) 432-7596. |
| How Supplied |
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Single-dose pack (3 tabs)—1 |
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