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ABOUT METOPIRONE®



 

What is Metopirone®?

Each soft capsule of Metopirone® contains 250 mg of metyrapone.

Indications:

Metopirone® is a diagnostic drug for testing hypothalamic-pituitary ACTH function.The metyrapone diagnostic test should be restricted to referral hospital centers.

 

Overnight single‑dose
Metopirone® test
Multiple‑dose
Metopirone® test
Where? Restricted to referral hospital centers
Under supervision of specialists
How? Ambulatory basis possible Hospitalization required
How many doses
of Metopirone®?
A unique dose 6 divided doses
Which dosage in adults? 30 mg/kg at midnight
(maximum 3 g)
700mg every 4 hrs, for 24 hrs (total dose of 4.5 g)
Which dosage in children? Same dosage as in adults 15 mg/kg (minimum 250 mg)
every 4 hrs, for 24 hrs
Which parameters
should be measured?
1 blood sample:
Plasma 11‑DOC and/or ACTH levels
3 consecutive 24‑hrs urine samples:
24‑hrs urinary 17‑OHCS and/or
17‑KGS levels
When to measure? Early in the following morning
(7.30 am‑8.00 am)
The day before, the day of and the day
after Metopirone® administration

Table prepared by HRA Pharma based on Metopirone USPI.

Abbreviations:
ACH: Adrenocorticotropic hormone; 11-DOC: 11-deoxycortisol; 17–OHCS: 17-hydroxycorticosteroids; 17–KGS: 17 ketogenic steroids.

Method of administration:

The capsules should be taken with yogurt or milk

Mode of action:1,2

Metopirone® is an inhibitor of endogenous adrenal corticosteroid synthesis.
It reduces cortisol and corticosterone production by inhibiting the 11 β – hydroxylation reaction in the adrenal cortex.

As a consequence: compensatory rise in ACTH and increase in:

  • 11-deoxycortisol (S compound) and ACTH levels in plasma (OMT)
  • 17-OHCS and 17-KGS levels in urine (STD)

Figure prepared by HRA Pharma based on Metopirone USPI.

References

1. Metopirone® summary of product characteristics (USA), January 2018
2. Avgerinos PC, et al. Ann Intern Med. 1994; 121(5): 318-27



(Link to the Metopirone USPI (non modifiable PDF file)).

Indication and Important Safety Information

Metopirone® is a diagnostic drug for testing hypothalamic-pituitary ACTH function.

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

The following adverse reactions have been observed after use of Metopirone®: Hypotension, nausea, vomiting, abdominal discomfort or pain, headache, dizziness, sedation, allergic rash, and rarely, decreased white blood cell count or bone marrow depression.

See Instructions for Use and full prescribing information in the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-855-M-Pirone (1-855-674-7663) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HRA Pharma, 15, rue Béranger, 75003 Paris, FRANCE
Tel: +33 (0) 1 40 33 11 30 / Fax: +33 (0) 1 40 33 12 31
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Last updated: February 2018; MET-WEB-0218-US