Australia - English - Department of Health (Therapeutic Goods Administration)

ms health pty ltd - mifepristone, quantity: 200 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; povidone - mifepristone linepharma 200 mg tablet is indicated in females of childbearing age for preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.

United States - English - NLM (National Library of Medicine)

genbiopro, inc. - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. - administration of mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions: confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) [ see warnings and precautions ( 5.4)] chronic adrenal failure (risk of acute adrenal insufficiency) concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency) history of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported [ see adverse reactions ( 6.2)]) hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) in

Australia - English - Department of Health (Therapeutic Goods Administration)

ms health pty ltd - mifepristone, quantity: 200 mg - tablet - excipient ingredients: maize starch; microcrystalline cellulose; magnesium stearate; povidone; colloidal anhydrous silica - ms-2 step is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation. it is recommended that the duration of pregnancy (i.e., up to 63 days gestation) be confirmed by ultrasound. in the event that an ultrasound is not possible, extra caution should be exercised. ultrasound is also useful to exclude ectopic pregnancy.

Zimbabwe - English - Medicines Control Authority

china resources zizhu pharmaceutucals co ltd - mifepristone; misoprostol - tablet; oral - 200mg;200mcg

United States - English - NLM (National Library of Medicine)

pci pharma services canada, inc. - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. - administration of mifepristone tablets, 200mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions: confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) [see warnings and precautions (5.4)] chronic adrenal failure (risk of acute renal insufficiency) concurrent long-term corticosteroid therapy (risk of acute renal insufficiency) history of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported [see adverse reactions (6.2]) hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) - confirmed or suspected ectopic pregna

Australia - English - Department of Health (Therapeutic Goods Administration)

ms health pty ltd - misoprostol, quantity: 200 microgram - tablet - excipient ingredients: hypromellose; microcrystalline cellulose; sodium starch glycollate; hydrogenated castor oil - gymiso is indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.

United States - English - NLM (National Library of Medicine)

corcept therapeutics incorporated - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - mifepristone 300 mg - korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. limitations of use: - korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to cushing's syndrome. korlym is contraindicated in: - pregnancy [see dosage and administration (2.1), use in specific populations (8.1,8.3)] - patients taking drugs metabolized by cyp3a such as simvastatin, lovastatin, and cyp3a substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [see drug interactions (7.1) and clinical pharmacology (12.3)] - patients receiving systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because korlym antagonizes the effect of glucocorticoids. - women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma. - patients with known hypersensitivity to mifepristone or to any of the product components. risk summary korlym is contraindicated in pregnancy because the use of korlym results in pregnancy loss. there are no data that assess the risk of birth defects in women exposed to korlym during pregnancy. available data limited to exposure following a single dose of mifepristone during pregnancy showed a higher rate of major birth defects compared to the general population comparator (see data) . mifepristone administered to pregnant mice, rats, and rabbits during organogenesis caused pregnancy loss in all species at clinically relevant doses based on body surface area comparisons (see data) . the inhibition of both endogenous and exogenous progesterone by mifepristone at the progesterone receptor results in pregnancy loss. if korlym is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see contraindications (4)] the estimated risk of fetal loss is elevated in patients with active cushing's syndrome (24-30%), and the risk of major birth defects is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. data human data there are no data on long term exposure to mifepristone in pregnancy. available data are limited to exposure to a single dose of mifepristone for pregnancy termination. in a prospective study in france of 46 pregnancies exposed to a single dose of mifepristone alone and 59 pregnancies exposed to a single dose of mifepristone and misoprostol, the overall major birth defect rate (4%) was greater than the general population background rate of 2 to 3% (2 birth defects in each group). there was no pattern of birth defects identified. animal data reproductive studies were performed in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than human exposure at the maximum clinical dose, based on body surface area). because of the anti-progestational activity of mifepristone, fetal losses were much higher than in control animals. skull deformities were detected in rabbit studies at less than human exposure, although mifepristone did not cause any adverse developmental effects in rats or mice during organogenesis. these deformities were most likely due to the mechanical effects of uterine contractions resulting from antagonism of the progesterone receptor. risk summary mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for korlym and any potential adverse effects on the breastfed child from korlym or from the underlying maternal condition. clinical considerations to minimize exposure to a breastfed infant, women who discontinue or interrupt korlym treatment may consider pumping and discarding milk during treatment and for 18-21 days (5-6 half-lives) after the last dose, before breastfeeding. data available published data based on intake of a single dose of 600 mg of mifepristone in 10 breastfeeding women who were 6-12 months postpartum showed a small amount in breast milk (the estimated relative infant dose was 0.5%). the half-life of mifepristone is longer with repeat dosing compared to a single dose; therefore, there may be greater exposure with long term use. pregnancy testing due to its anti-progestational activity, korlym causes pregnancy loss. perform pregnancy testing before the initiation of treatment with korlym or if treatment is interrupted for more than 14 days in females of reproductive potential. contraception recommend non-hormonal contraception for the duration of treatment and for one month after stopping treatment . korlym interferes with the effectiveness of hormonal contraceptives. [see drug interactions (7.6)] safety and effectiveness of korlym in pediatric patients have not been established. clinical studies with korlym did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger people. the maximum dose should not exceed 600 mg per day in renally impaired patients. [see clinical pharmacology (12.3)] in patients with mild to moderate hepatic impairment, the maximum dose should not exceed 600 mg per day. the pharmacokinetics of mifepristone in patients with severe hepatic impairment has not been studied, and korlym should not be used in these patients. [see clinical pharmacology (12.3)]

Australia - English - Department of Health (Therapeutic Goods Administration)

ms health pty ltd - mifepristone -

India - English - Central Drugs Standard Control Organization

cadila pharma - mifepristone, misoprostol - tablet - mifopristone 200mg, misoprostol 200 μg - 1 tablet of mifepristone 200, 4 tablets of misoprostol 200 mcg - hormones, contraceptives and related drugs - medical termination of pregnancy of up to 49 days, cervical dilatation prior to surgical termination of pregnancy in the first trimester, therapeutic termination of pregnancy for medical reasons beyond the first trimester, labor induction in case of fetal death in utero.

Israel - English - Ministry of Health

a. lapidot pharmaceuticals, ltd - mifepristone - tablets - mifepristone 200 mg - mifepristone - mifepristone - medical termination of developing intra-uterine pregnancy.- in sequential use with a prostaglandin analogue up to 63 days of amenorrhea.- softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester.- preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester).- labour induction in foetal death in utero.in patients where prostaglandin or oxytocin cannot be use.