INZIRQO

Clinical summary

Indications and usage 1 INDICATIONS & USAGE INZIRQO™ (hydrochlorothiazide) is a thiazide diuretic indicated for: The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction (1.1). The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including the nephrotic syndrome in adult and pediatric patients. (1.2). 1.1 Hypertension INZIRQO is indicated for the treatment of hypertension in adult and pediatric patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes., including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. INZIRQO can be used alone or in combination with other antihypertensive agents. 1.2 Edema Treatment of edema associated with congestive heart failure, hepatic cirrhosis, and renal disease including the nephrotic syndrome in adult and pediatric patients. Dosage and administration 2 DOSAGE & ADMINISTRATION For the treatment of hypertension in adults: The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses(2.1). For the treatment of edema in adults: The recommended adult dosage is 25 mg to 100 mg orally daily as a single or divided dose. Consider intermittent therapy to reduce the risk of electrolyte imbalances, i.e., administration on alternate days or on 3 to 5 days each week (2.2). For the treatment of hypertension and edema in pediatric patients: The recommended pediatric dosage is 1 mg/kg to 2 mg/kg orally per day in single or two divided doses. Do not exceed 37.5 mg per day in patients less than 2 years of age or 100 mg per day in children 2 to less than 13 years of age. Patients less than 6 months of age may require doses up to 3 mg/kg orally per day in two divided doses (2.1, 2.2). 2.1 Recommended Dosage for the Treatment of Hypertension The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses. Pediatric Patients: The recommended dose in pediatric patients is 1 to 2 mg/kg per day in one or two divided doses not to exceed 37.5 mg in patients less than 2 years of age and 100 mg in patients 2 to less than 13 years of age. In pediatric patients less than 6 months of age, doses up to 3 mg/kg per day in two divided doses may be required. 2.2 Recommended Dosage for the Treatment of Edema The recommended adult dosage is 25 mg to 100 mg orally daily