Metopirone (Metyrapone)

Brand Name

Metopirone

Generic Name

Metyrapone

View Brand Information

FDA approval date: January 25, 1962

Classification: Adrenal Steroid Synthesis Inhibitor

Form: Capsule

What is Metopirone (Metyrapone)?

Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients.

Approved To Treat

Addison's Disease

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Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

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Brand Information

Metopirone (Metyrapone)

1INDICATIONS AND USAGE

Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients.

2DOSAGE FORMS AND STRENGTHS

Capsules: Metopirone 250 mg soft gelatin, white to yellowish‑white, oblong, opaque, imprinted with "HRA" on one side in red ink.

3CONTRAINDICATIONS

Metopirone is contraindicated in patients with adrenal cortical insufficiency or hypersensitivity to Metopirone or to any of its excipients.

4ADVERSE REACTIONS

The following adverse reactions associated with the use of Metopirone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular System:Hypotension
Gastrointestinal System:Nausea, vomiting, abdominal discomfort or pain
Central Nervous System:Headache, dizziness, sedation
Dermatologic System:Allergic rash
Hematologic System:Leukopenia, anemia, and/or thrombocytopenia

5OVERDOSAGE

Death occurred in a child after two doses of Metopirone 2 g.

6DESCRIPTION

Metopirone (metyrapone capsules) is an adrenal steroid synthesis inhibitor, 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

Metyrapone 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 226.27.

Inactive Ingredients: Ethyl vanillin, gelatin, glycerol, macrogol 400, macrogol 4000, paramethoxy acetophenone, purified water, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide, + red ink (aluminum chloride hexahydrate, carminic acid, hypromellose, propylene glycol, sodium hydroxide).

7PATIENT COUNSELING INFORMATION

Advise patient to read the FDA-approved labeling (Patient Information).

Advise patient that Metopirone may induce acute adrenal insufficiency (nausea, vomiting, abdominal pain, hypotension)

Advise patient that Metopirone may cause dizziness and sedation. Advise patients not to drive or operate machinery until these effects have passed

8PRINCIPAL DISPLAY PANEL - 250 mg Bottle Carton

NDC 76336-455-18

Metopirone

18 capsules

HRA Pharma

PRINCIPAL DISPLAY PANEL - 250 mg Bottle Carton