HEMICLOR

5 WARNINGS AND PRECAUTIONS Acute Kidney Injury: Patients with pre-existing kidney disease may be at higher risk. ( 5.1 ). Electrolyte Abnormalities: Monitor serum electrolytes periodically ( 5.2 ). Metabolic Disturbances ( 5.3 ). Systemic Lupus Erythematosus ( 5.4 ). 5.1 Acute Kidney Injury Monitor kidney function periodically. Diuretics can cause hypovolemia which may precipitate acute kidney injury. Patients with chronic kidney disease, heart failure, or volume depletion may be at particular risk of developing acute renal failure on Chlorthalidone. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on chlorthalidone. 5.2 Electrolyte Abnormalities Chlorthalidone can cause hypokalemia, hyponatremia, hypochloremic alkalosis, and hypomagnesemia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Hypokalemia is dose dependent. Monitor and correct serum electrolytes prior to use and monitor periodically. 5.3 Metabolic Disturbances Chlorthalidone may increase blood sugar levels, affect diabetes control, and cause changes in the need for diabetes medication. Chlorthalidone may raise serum levels of cholesterol and triglycerides. Monitor blood sugar and lipid levels. Chlorthalidone may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Increases in serum uric acid are dose related. Chlorthalidone decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Chlorthalidone. 5.4 Systemic Lupus Erythematosus The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

6 ADVERSE REACTIONS The following adverse reactions are described in more detail elsewhere in the label; Acute Kidney Injury [see Warnings and Precautions (5.1) ] Electrolyte Abnormalities [see Warnings and Precautions (5.2) ] Metabolic Disturbances [see Warnings and Precautions (5.3) ] The following adverse reactions have been observed with chlorthalidone, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions: dizziness, paresthesias, headache. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis). Cardiovascular Reaction: Orthostatic hypotension. Other Adverse Reactions: muscle spasm, weakness, restlessness, impotence, xanthopsia. The most frequently expected adverse drug reactions among patients receiving thiazide-like diuretics are electrolyte abnormalities and metabolic disturbances ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.