FDA approves first spironolactone oral suspension


The Food and Drug Administration has approved CaroSpir, the first oral suspension form of spironolactone, the aldosterone antagonist that was first approved in 1960, according to an announcement from CMP Pharma.

CaroSpir is intended for the treatment of New York Heart Association class III-IV heart failure and reduced ejection fraction, usually in combination with other treatments. CaroSpir is also indicated as an add-on medication for the treatment of hypertension, and for the treatment of edema in cirrhotic patients who have not adequately responded to fluid and sodium restriction.

CaroSpir is contraindicated for patients who have hyperkalemia or Addison’s disease, or who are currently using eplerenone. The most common adverse events associated with CaroSpir are hyperkalemia, hypotension, and worsening renal function; electrolyte and metabolic abnormalities; gynecomastia; and impaired neurological function/coma in patients with hepatic impairment, cirrhosis, and ascites.

“CaroSpir provides a stable, ready to use, and consistent liquid treatment option for adult patients. Up until now, these patients have been prescribed a pharmacy-compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians,” Gerald Sakowski, CEO at CMP Pharma, said in the press release.

Find the full press release on the CMP Pharma website.

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