Metopirone 250 mg/1
Metyrapone · CAPSULE, GELATIN COATED · HRA Pharma Rare Diseases
Metopirone is a capsule, gelatin coated containing metyrapone at 250 mg/1, taken oral. Manufactured by HRA Pharma Rare Diseases.
Key Facts
- Brand Name
- Metopirone
- Generic Name
- Metyrapone
- NDC Code (Product)
76336-455- Manufacturer
- HRA Pharma Rare Diseases
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA012911
- Drug Class
- Adrenal Steroid Synthesis Inhibitor [EPC]
- Marketing Start
- 01/25/1962
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Single-Dose Short Test: 30 mg/kg at midnight ( 2.2 ) 2.1 Important Information Before Conducting Metopirone Testing Stop drugs affecting pituitary or adrenocortical function before administration of Metopirone in accordance with half-life of the drugs (consider at least 5 half-lives to avoid any interference with Metopirone testing). [see Drug Interactions (7.1) ] . Assess ability of patient's adrenals to respond to exogenous ACTH before Metopirone is employed as a test [see Warnings and Precautions (5.1) ] . 2.2 Single-Dose Short Test- Recommended Dose and Interpretation This test, usually given on an outpatient basis, determines plasma 11-desoxycortisol and/or ACTH levels after a single dose of Metopirone. Patients with suspected adrenocortical insufficiency based on the test results previously performed should be hospitalized overnight as a precautionary measure ( see Warnings and Precaution (5.1) ). Recommended Dose In adult and pediatric patients, the recommended single dose is 30 mg/kg (maximum 3 grams of Metopirone) administered at midnight with milk/yogurt or snack. The blood sample for the assay is taken early the following morning (7:30-8:00 a.…
Contraindications
4 CONTRAINDICATIONS Metopirone is contraindicated in patients with adrenal cortical insufficiency or hypersensitivity to Metopirone or to any of its excipients. In patients with adrenal cortical insufficiency ( 4 ) Hypersensitivity to Metopirone or to any of its excipients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anticonvulsants, psychotropic, hormone preparations, corticosteroids, antithyroid agents, cyproheptadine: may affect the results of the metyrapone test. ( 7.1 ) Acetaminophen: Avoid concomitant use with Metopirone. ( 7.2 ) 7.1 Effect of Other Drugs on Metopirone Anticonvulsants, psychotropic drugs, hormone preparations, corticosteroids, antithyroid agents and cyproheptadine may affect the results of the Metopirone test. If these drugs cannot be withdrawn, the necessity of carrying out the Metopirone test should be reviewed. 7.2 Effect of Metopirone on Other Drugs Acetaminophen Metopirone inhibits the glucuronidation of acetaminophen, which may decrease elimination of acetaminophen and lead to increased risk of adverse reactions related to acetaminophen. Avoid concomitant use of Metopirone with acetaminophen.
Adverse Reactions
6 ADVERSE 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 Adverse reactions include: hypotension, nausea, vomiting, abdominal discomfort or pain, headache, dizziness, sedation, allergic rash, leukopenia, anemia, and/or thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Inc. at 844-597-6373 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Metopirone used for?
Metopirone contains Metyrapone. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.
Is Metopirone a controlled substance?
Metopirone is not classified as a controlled substance by the DEA.
What is the generic name for Metopirone?
The generic name for Metopirone is Metyrapone. There are no other listed brand versions of Metyrapone.
What is the NDC code for Metopirone 250 mg/1?
The NDC (National Drug Code) for Metopirone 250 mg/1 is 76336-455, listed by HRA Pharma Rare Diseases.
Other Metopirone Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)