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

actavis pharma, inc. - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - 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: - mifepristone tablets should not be used in the treatment of patients with type 2 diabetes unless it is secondary to cushing’s syndrome. mifepristone 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 mifepristone 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 mifepristone is contraindicated in pregnancy because the use of mifepristone results in pregnancy loss. there are no data that assess the risk of birth defects in women exposed to mifepristone 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 mifepristone 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% to 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% to 4% and 15% to 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 mifepristone and any potential adverse effects on the breastfed child from mifepristone or from the underlying maternal condition. clinical considerations to minimize exposure to a breastfed infant, women who discontinue or interrupt mifepristone treatment may consider pumping and discarding milk during treatment and for 18 to 21 days (5 to 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 to 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, mifepristone causes pregnancy loss. perform pregnancy testing before the initiation of treatment with mifepristone 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. mifepristone interferes with the effectiveness of hormonal contraceptives. [see drug interactions (7.6)] safety and effectiveness of mifepristone in pediatric patients have not been established. clinical studies with mifepristone 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 mifepristone should not be used in these patients [see clinical pharmacology (12.3)] .

Ireland - English - HPRA (Health Products Regulatory Authority)

nordic group b.v. - misoprostol - tablet - 400 microgram(s) - misoprostol

Ireland - English - HPRA (Health Products Regulatory Authority)

exelgyn - misoprostol - tablet - 400 microgram(s) - misoprostol

Canada - English - Health Canada

linepharma international limited - mifepristone; misoprostol - kit - 200mg; 200mcg - mifepristone 200mg; misoprostol 200mcg - oxytocics

Canada - English - Health Canada

linepharma international limited - misoprostol; mifepristone - kit - 200mcg; 200mg - misoprostol 200mcg; mifepristone 200mg

Kenya - English - Pharmacy and Poisons Board

sun pharmaceutical industries limited acme plaza andheri kurla road andheri(e) mumbai- - combipack of mifepristone & misoprostol tablets - tablet - mifepristone - 200 mg misoprostol - 200 mcg - antiprogestogens

Kenya - English - Pharmacy and Poisons Board

lords healthcare ltd. capitol hill towers, cathedral road, 49397-00100 - mifepristone & misoprostol bp - tablet - 200mg & 200mcg - mifepristone combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare ltd - diclofenac sodium; misoprostol - modified-release tablet - 75 mg/200 microgram(s) - antiinflammatory/antirheumatic agents in combination with corticosteroids; acetic acid derivatives and related substances

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)]

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - misoprostol - tablets - misoprostol 200 mcg - misoprostol - misoprostol - for the treatment of duodenal and gastric ulcer.treatment and prevention nsaid induced ulcers lesions, erosions, while nsaid therapy continues.use in conjunction with mifepristone subject to the approval of a committee for the termination of pregnancy according to the israeli penal law 1977.first-trimester pregnancy failure: use is intended for emptying the uterus in states of first trimester pregnancy failure, including: presentation of a pregnancy sac in the uterus with no fetal echo, missed abortion (until week 11+6 and a fetus 40 mm in length) or incomplete abortion. the preparation is to be used after location of the sac in the uterus has been proved and the diagnosis of pregnancy failure is certain. the preparation can be used for this purpose in an ambulatory setting. the dosage and route of administration will be similar to the use of cytotec in pregnancy termination after using mifegyne. informed consent and medical surveillance are required.softening and dilation of the cervix for performing intrauterine procedures, such as: curettage, hysteroscopy, iud insertion and others, according to clinical judgment. the preparation can be used for this purpose in an ambulatory setting. the route of administration (vaginal, sublingual, buccal, oral or rectal) and the dosage are according to the decision of the attending doctor.