New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - metyrapone 250mg - soft gelatin capsule - 250 mg - active: metyrapone 250mg excipient: acetanisole ethyl hydroxybenzoate as the sodium salt ethyl vanillin gelatin glycerol   ink macrogol 400 macrogol 4000 purified water sodium propyl hydroxybenzoate titanium dioxide - therapeutic applications metopirone can be employed as supplementary therapy in conditions associated with overproduction of glucocorticoids and mineralocorticoids, particularly when causal treatment is not possible. cushing's syndrome, especially when related to adrenal tumours hyperaldosteronism, resistant oedema

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

chiesi australia pty ltd - metyrapone, quantity: 250 mg - capsule, soft - excipient ingredients: macrogol 400; sodium ethyl hydroxybenzoate; sodium propyl hydroxybenzoate; macrogol 4000; glycerol; gelatin; purified water; acetanisole; ethyl vanillin; titanium dioxide; propylene glycol; hypromellose; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal - diagnostic use,? for the diagnosis of latent acth deficiency such as in cases of known pituitary dysfunction or of a suspected pituitary tumour, as well as before and after surgical intervention in the region of the pituitary; and, to assess the degree of acth suppression during or after glucocorticoid therapy.,? for the differential diagnosis of states of adrenocortical hyperfunction in cushing's syndrome.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

hra pharma uk & ireland ltd - metyrapone - oral capsule - 250mg

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire hra pharma - metyrapone - capsule, soft - 250 milligram(s) - tests for pituitary function; metyrapone

Ireland - English - HPRA (Health Products Regulatory Authority)

hra pharma rare diseases - metyrapone - capsule, soft - 250 milligram(s) - tests for pituitary function; metyrapone

Malta - English - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - metyrapone - soft capsule - metyrapone 250 mg - diagnostic agents

Israel - English - Ministry of Health

cts ltd - metyrapone - capsules - metyrapone 250 mg - metyrapone - metyrapone - diagnostic test for acth insufficiency and in the differential diagnosis of acth dependant cushing’s syndrome. for the management of patient with endogenous cushing’s syndrome.

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

hra pharma rare diseases - metyrapone (unii: zs9kd92h6v) (metyrapone - unii:zs9kd92h6v) - metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. metopirone is contraindicated in patients with adrenal cortical insufficiency or hypersensitivity to metopirone or to any of its excipients. risk summary available data from published case series and reports on metopirone use in pregnant females are insufficient to identify a drug-associated risk of major birth defects or miscarriage. metyrapone crosses the placenta and may decrease fetal cortisol production (see data) . animal reproductive studies have not been conducted with metyrapone. metyrapone can decrease reproductive hormones by targeting adrenal androgenesis. data human data the metopirone test was administered to pregnant women in their second and third trimester of pregnancy and evidence was found that the fetal pituitary responded to the enzymatic block. transplacental transfer of metopirone has been shown in humans and the drug can impair the biosynthesis of fetal and placental steroids. there are a few published reports of low cortisol levels at birth in infants exposed in utero following chronic use of metyrapone in pregnant females. risk summary metyrapone and its active metabolite, metyrapol, are present in human milk. there are no available data on the effects of metyrapone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for metopirone and any potential adverse effects on the breastfed infant from metopirone or from the underlying maternal condition. metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in pediatric patients [see dosage and administration (2.1)]. clinical studies of metopirone did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. other reported clinical experience has not identified differences in responses between patients 65 years of age and older and younger adult patients. patients with cirrhosis may have an impaired response to metopirone.

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - metyrapone - capsule - metyrapone 250 mg - diagnostic agents

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - metyrapone - soft capsule - metyrapone 250 mg - diagnostic agents