Inzirqo

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).

• 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).

For Oral Suspension: When reconstituted as directed, INZIRQO is an off-white to light brown colored suspension with caramel, peppermint flavor containing 10 mg/mL of hydrochlorothiazide, USP.

Untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Monitor pregnant women with hypertension.

• Monitor kidney function periodically (5.1)
• Monitor and correct serum electrolytes prior to use and monitor periodically (5.2).
• Monitor blood sugar, lipid levels, uric acid and calcium levels periodically. (5.3)
• Exacerbation or activation of systemic lupus erythematosus (5.4)
• Acute angle-closure glaucoma and acute myopia (5.5)