Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Termination of pregnancy (≤49 days) 600 mg as a single dose, followed by misoprostol 400 mcg orally or gemeprost 1 mg vaginally 36-48 hr later. Termination of pregnancy up to 63 days 600 mg as a single dose followed by 1 mg gemeprost vaginally 36-48 hr later. Termination of pregnancy between 13-24 wk of gestation As adjunct to prostaglandin: 600 mg as a single dose given 36-48 hr prior to prostaglandin therapy. Induction of labour following intrauterine foetal death 600 mg/day for 2 consecutive days. Softening and dilatation of cervix prior to surgical termination of pregnancy 200 mg as a single dose given 36-48 hr prior to the procedure. Hyperglycaemia in Cushing's syndrome Initial: 300 mg once daily, may increase in increments of 300 mg at 2-4 wk intervals. Max: 1.2 g once daily (but not more than 20 mg/kg daily).
May be taken with or without food. Avoid grapefruit juice.
Termination of pregnancy: Confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, chronic adrenal failure, porphyria, haemorrhagic disorder. Concurrent anticoagulant therapy. Cushing's syndrome: Women w/ history of vag bleeding, endometrial hyperplasia w/ atypia or endometrial carcinoma. Pregnancy. Concomitant use w/ lovastatin, simvastatin and CYP3A4 substrates w/ narrow therapeutic range. Concurrent long-term corticosteroid use for serious medical conditions.
Special Precautions
Patient w/ haemostatic disorders or anaemia; malnutrition. Patients taking strong CYP3A4 inhibitors (when used in the treatment of Cushing's syndrome). Hepatic and renal impairment. Lactation. Monitoring Parameters Termination of pregnancy: Monitor Hb, haematocrit and RBC count in cases of heavy bleeding; CBC in patients who show signs of infection. Conduct clinical exam and/or ultrasound to confirm complete termination of pregnancy. Cushing's syndrome: Monitor thyroid function, serum glucose, psychiatric symptoms, signs/symptoms of adrenal insufficiency; cushingoid appearance.
Adverse Reactions
Uterine bleeding and cramps, chills, fever, malaise, dizziness, headache, diarrhoea, nausea, vomiting, urticaria, rash; hypokalaemia, GI disturbances, decreased appetite, drowsiness, fatigue, dyspnoea, anxiety, peripheral oedema, HTN, arthralgia, myalgia, back pain, endometrial thickening, cystic dilatation of endometrial glands, adrenal insufficiency, prolonged QT interval.
Potentially Fatal: Serious infections.
Drug Interactions
Increased serum levels w/ CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin). Decreased serum levels w/ CYP3A4 inducers (e.g. dexamethasone, rifampicin, phenytoin).
ATC Classification
G03XB01 - mifepristone ; Belongs to the class of antiprogestogens.
Disclaimer: This information is independently developed by CIMS based on mifepristone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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