WEST CONSHOHOCKEN, PA — The U.S. Food and Drug Administration (FDA) has approved HemiClor, a 12.5 mg tablet of chlorthalidone, for treating high blood pressure in adults. This new, lower-dose option is expected to provide doctors with more flexibility in managing hypertension according to the latest medical guidelines.
Chlorthalidone, a thiazide-like diuretic, has been a key part of high blood pressure treatment for many years. It is known for its long-lasting effects and proven cardiovascular benefits, making it a preferred choice in treatment guidelines, including the 2017 ACC/AHA hypertension guidelines. Clinical trials such as the ALLHAT and SHEP studies, funded by the National Heart, Lung, and Blood Institute, have shown that 12.5 mg doses are effective in reducing cardiovascular risks.
Previously, U.S. patients could only access higher-dose versions of chlorthalidone, such as 25 mg and 50 mg tablets. The approval of HemiClor fills this gap by offering a lower starting dose that helps reduce the risks of side effects like low potassium (hypokalemia) and high uric acid levels (hyperuricemia).
Dr. William B. White, Professor Emeritus at the University of Connecticut School of Medicine, commented, “Chlorthalidone has been a cornerstone in hypertension treatment for years. The availability of a 12.5 mg dose in the U.S. gives doctors more options, especially for patients with stage 1 or stage 2 hypertension.”
This new treatment option is especially beneficial for elderly patients who may be more sensitive to higher doses. PRM Pharma’s low-dose formulation supports personalized care, meeting an important need in hypertension treatment.
Joseph T. McDevitt, President and CEO of PRM Pharma, said, “We are excited to introduce HemiClor as a new option for managing hypertension. Our goal is to address clinical needs by developing low-dose treatments that support evidence-based care. Lower doses may provide a more tailored approach to starting treatment.”
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