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Metopirone
Overview
What is Metopirone?
Metopirone, metyrapone USP, is an inhibitor of endogenous adrenal corticosteriod synthesis, available as 250-mg capsules for oral administration. Its chemical name is 2-methyl-1, 2-di-3-pyridyl-1-propanone, and its structural formula is
Metopirone structural formula
Metyrapone USP is a white to light amber, fine, crystalline powder, having a characteristic odor. It is sparingly soluble in water, and soluble in methanol and in chloroform. It forms water-soluble salts with acids. Its molecular weight is 226.28.
: Polyethylene glycol, glycerin, gelatin, sodium ethyl, hydroxybenzoate, sodium propyl hydroxybenzoate, ethyl vanillin, 4-methoxyacetophenone, titatnium dioxide, red ink.
What does Metopirone look like?
What are the available doses of Metopirone?
Sorry No records found.
What should I talk to my health care provider before I take Metopirone?
Sorry No records found
How should I use Metopirone?
Metopirone is a diagnostic drug for testing hypothalamic‑pituitary ACTH function.
This test, usually given on an outpatient basis, determines plasma 11-desoxycortisol and/or ACTH levels after a single dose of Metopirone. The patient is given 30 mg/kg (maximum 3 g Metopirone) at midnight with yogurt or milk. The same dose is recommended in children. The blood sample for the assay is taken early the following morning (7:30-8:00 a.m.). The plasma should be frozen as soon as possible. The patient is then given a prophylactic dose of 50 mg cortisone acetate.
What interacts with Metopirone?
Metopirone is contraindicated in patients with adrenal cortical insufficiency, or hypersensitivity to Metopirone or to any of its excipients.
What are the warnings of Metopirone?
Keep out of the reach of children.
What are the precautions of Metopirone?
General
Ability of adrenals to respond to exogenous ACTH should be demonstrated before Metopirone is employed as a test. In the presence of hypo‑ or hyperthyroidism, response to the Metopirone test may be subnormal.
Since Metopirone may cause dizziness and sedation, patients should exercise caution when driving or operating machinery.
Laboratory Tests
See INTERPRETATION.
Drug Interactions
Drugs affecting pituitary or adrenocortical function, including all corticosteroid therapy, must be discontinued prior to and during testing with Metopirone.
The metabolism of Metopirone is accelerated by phenytoin; therefore, results of the test may be inaccurate in patients taking phenytoin within two weeks before. A subnormal response may occur in patients on estrogen therapy.
Metopirone inhibits the glucuronidation of acetaminophen and could possibly potentiate acetaminophen toxicity.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long‑term carcinogenicity and reproduction studies in animals have not been conducted. Metopirone was not mutagenic with or without metabolic activation in three strains of bacteria.
Pregnancy Category C
A subnormal response to Metopirone may occur in pregnant women. Animal reproduction studies have not been conducted with Metopirone. The Metopirone test was administered to 20 pregnant women in their second and third trimester of pregnancy and evidence was found that the fetal pituitary responded to the enzymatic block. It is not known if Metopirone can affect reproduction capacity. Metopirone should be given to a pregnant woman only if clearly needed.
Animal reproduction studies adequate to evaluate teratogenicity and postnatal development have not been conducted with Metopirone.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metopirone is administered to a nursing woman.
Geriatric Use
Clinical studies of Metopirone did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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What are the side effects of Metopirone?
Cardiovascular System
Gastrointestinal System
Central Nervous System
Dermatologic System
Hematologic System
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What should I look out for while using Metopirone?
Metopirone is contraindicated in patients with adrenal cortical insufficiency, or hypersensitivity to Metopirone or to any of its excipients.
Metopirone may induce acute adrenal insufficiency in patients with reduced adrenalsecretory capacity.
What might happen if I take too much Metopirone?
How should I store and handle Metopirone?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Capsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, FranceCapsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, FranceCapsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, FranceCapsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, FranceCapsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, FranceCapsules 250 mg -- soft gelatin, white to yellowish‑white, oblong, opaque, imprinted HRA on one side in red ink.Bottles of 18............................................................................................NDC 76336‑455‑18Do not store above 30ºC (86ºF).Protect from moisture and heat.Dispense in tight container (USP).Address medical inquiries to:Direct Success Inc.1710 Hwy 34Farmingdale, NJ 07727(855) 674-7663(855) M-PironeFax: (855) 674-6767Manufactured by:Catalent Germany Eberbach GmbHEberbach, GermanyFor:Laboratoire HRA PharmaParis, France
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacological effect of Metopirone is to reduce cortisol and corticosterone production by inhibiting the 11-beta-hydroxylation reaction in the adrenal cortex. Removal of the strong inhibitory feedback mechanism exerted by cortisol results in an increase in adrenocorticotropic hormone (ACTH) production by the pituitary. With continued blockade of the enzymatic steps leading to production of cortisol and corticosterone, there is a marked increase in adrenocortical secretion of their immediate precursors, 11-desoxycortisol and desoxycorticosterone, which are weak suppressors of ACTH release, and a corresponding elevation of these steroids in the plasma and of their metabolites in the urine. These metabolites are readily determined by measuring urinary 17‑hydroxycorticosteroids (17-OHCS) or 17-ketogenic steroids (17-KGS). Because of these actions, Metopirone is used as a diagnostic test, with urinary 17-OHCS measured as an index of pituitary ACTH responsiveness. Metopirone may also suppress biosynthesis of aldosterone, resulting in a mild natriuresis.
Non-Clinical Toxicology
Metopirone is contraindicated in patients with adrenal cortical insufficiency, or hypersensitivity to Metopirone or to any of its excipients.Metopirone may induce acute adrenal insufficiency in patients with reduced adrenalsecretory capacity.
Drugs affecting pituitary or adrenocortical function, including all corticosteroid therapy, must be discontinued prior to and during testing with Metopirone.
The metabolism of Metopirone is accelerated by phenytoin; therefore, results of the test may be inaccurate in patients taking phenytoin within two weeks before. A subnormal response may occur in patients on estrogen therapy.
Metopirone inhibits the glucuronidation of acetaminophen and could possibly potentiate acetaminophen toxicity.
Ability of adrenals to respond to exogenous ACTH should be demonstrated before Metopirone is employed as a test. In the presence of hypo‑ or hyperthyroidism, response to the Metopirone test may be subnormal.
Since Metopirone may cause dizziness and sedation, patients should exercise caution when driving or operating machinery.
Cardiovascular System
Gastrointestinal System
Central Nervous System
Dermatologic System
Hematologic System
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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