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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.

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Last updated: June 2019; MET – WEB – 0619 – US