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.

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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
Chemical Structure
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