Katerzia Approved as First Oral Suspension Form of Amlodipine
July 8, 2019 – The U.S. FDA has approved Katerzia™ (amlodipine) 1mg/mL oral suspension, a new dosage form of amlodipine manufactured by Azurity Pharmaceuticals. It is indicated to lower high blood pressure in adults and children at least six years of age who have hypertension. The FDA also approved Katerzia to treat adults who have coronary artery disease, including chronic stable angina, vasospastic angina (Prinzmetal’s or variant angina), and angiographically documented coronary artery disease (in patients without heart failure or an ejection fraction of less than 40%).
The first oral liquid form of amlodipine available on the U.S. market, Katerzia offers an option for patients who may benefit from using an oral suspension rather than other dosage forms currently available. Recommended dosing varies based on individual patient factors. For adults, the starting dose is 5mg orally once per day, and the maximum dose should not exceed 10mg daily. Fragile, small, or elderly patients, or patients who have hepatic insufficiency may be started on 2.5mg once daily. For pediatric patients, the starting dose is 2.5mg to 5mg once daily. Doses in excess of 5mg have not been studied in pediatric patients. The product must be refrigerated and should be shaken well before each administration.
Katerzia will be available in 150mL bottles. Azurity has not yet announced launch or pricing plans.