Generic Medicine Info
May be taken with or without food. Avoid grapefruit juice.
Termination of pregnancy: Chronic adrenal failure, uncontrolled severe asthma, inherited porphyria, intrauterine device in place, ectopic pregnancy, pregnancy not confirmed by ultrasound scan or biological test, suspected extra-uterine pregnancy, undiagnosed adnexal mass, haemorrhagic disorder. Concomitant use with anticoagulant or long-term corticosteroid therapy. Treatment of hyperglycaemia in patients with Cushing's syndrome: History of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma. Pregnancy. Concomitant use with lovastatin, simvastatin or CYP3A substrates with narrow therapeutic ranges (e.g. ciclosporin, fentanyl, quinidine, tacrolimus, sirolimus, dihydroergotamine, ergotamine), long-term corticosteroid therapy for life-saving purposes (e.g. immunosuppression following organ transplant).
Special Precautions
Termination of pregnancy: Patient with history and active CV disease, haemostatic disorders, hypocoagulability, anaemia. Treatment of hyperglycaemia in patients with Cushing's syndrome: Patient with haemorrhagic disorder, hypokalaemia, adrenal insufficiency, CV disease. Concomitant use with anticoagulants, QT-prolonging agents, strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin). Hepatic and renal impairment. Lactation. Patient counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Termination of pregnancy: Monitor Hb, haematocrit and RBC count in cases of heavy bleeding; CBC in patients who show signs of infection. Confirm pregnancy and Rh status prior to termination of pregnancy. Conduct clinical exam, hCG testing or ultrasound to confirm complete termination of pregnancy. Treatment of hyperglycaemia in patients with Cushing's syndrome: Monitor K level (1-2 weeks after initiation or dose increase, then periodically thereafter), thyroid function, blood sugar, psychiatric symptoms and cushingoid appearance. Monitor for signs and symptoms of adrenal insufficiency.
Adverse Reactions
Significant: Adrenal insufficiency, hypokalaemia, QT prolongation. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal cramps, dry mouth, constipation. General disorders and administration site conditions: Fatigue, peripheral oedema. Infections and infestations: Bacterial or viral infection, sinusitis, nasopharyngitis. Investigations: Abnormal thyroid function test. Metabolism and nutrition disorders: Decreased appetite, anorexia. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, back pain, pain in extremity. Nervous system disorders: Headache, dizziness, somnolence. Psychiatric disorders: Anxiety. Reproductive system and breast disorders: Uterine contractions, endometrial hypertrophy. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, toxic epidermal necrolysis. Vascular disorders: Hypertension.
Potentially Fatal: Toxic and septic shock.
Drug Interactions
Increased serum concentration with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin). Decreased serum concentration with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine). May increase serum concentration of CYP2C8/2C9 substrates (e.g. fluvastatin, NSAIDs, repaglinide) and CYP2B6 substrates (e.g. efavirenz, bupropion). May diminish the therapeutic effect of hormonal contraceptives. May enhance the effect of QT-prolonging agents.
CIMS Class
Drugs Acting on the Uterus
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 © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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