Medication Monitor

Generic Name (Trade Name—Company)
July 16, 2019

Amlodipine oral suspension

(Katerzia—Azurity Pharmaceuticals)
FDA approves first amlodipine oral suspension to treat hypertension

Azurity Pharmaceuticals announced FDA approval of the first amlodipine oral suspension, 1 mg/mL, to treat hypertension in adults and pediatric patients ages 6 years and older and coronary artery disease in adults.

The calcium channel blocker may be used alone or in combination with other antihypertensive and antianginal agents.

It comes as a ready-to-use (simply shake) oral suspension for patients who require or prefer an oral liquid option of amlodipine. The recommended starting dose for adults is 5 mg orally once daily, with the maximum dose 10 mg once daily. For small, fragile, or older adult patients or patients with hepatic insufficiency, the starting dose is 2.5 mg once daily. The pediatric starting dose is 2.5 mg to 5 mg once daily.

The most common adverse reaction is dose-related edema. Other adverse experiences not dose related but reported with an incidence greater than 1% are fatigue, nausea, abdominal pain, and somnolence.