INDICATIONS AND 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.
- The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including nephrotic syndrome in adult and pediatric patients.
CONTRAINDICATIONS
INZIRQO is contraindicated:
- in patients with anuria.
- in patients with hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO.
- in patients with hypersensitivity to sulfonamide-derived drugs.
WARNINGS AND PRECAUTIONS
Impaired Renal Function: Diuretics can cause hypovolemia which may precipitate acute kidney injury. Monitor kidney function periodically. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on INZIRQO.
Electrolyte Abnormalities: INZIRQO can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic alkalosis. Monitor and correct serum electrolytes prior to use and monitor periodically. Discontinue INZIRQO if hypokalemia is associated with clinical symptoms (e.g., ECG changes, muscular weakness).
Metabolic Disturbances: INZIRQO may increase blood sugar levels; raise serum levels of cholesterol and triglycerides; raise the serum uric acid level; and decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor blood sugar, lipid levels, uric acid and calcium levels periodically.
Systemic Lupus Erythematosus: Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Acute Angle-Closure Glaucoma and Acute Myopia: Hydrochlorothiazide can cause an idiosyncratic reaction resulting in acute angle closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions. Untreated acute angle-closure glaucoma may result in permanent vision loss. Discontinue INZIRQO if symptoms of acute angle-closure glaucoma or acute myopia occur.
ADVERSE REACTIONS
Adverse reactions include hypokalemia, hyponatremia, hypomagnesemia, hyperglycemia, hyperuricemia, hyperlipidemia and hypotension.
DRUG INTERACTIONS
- Non-Steroidal Anti-Inflammatory Agents (NSAIDs): Administration of an NSAID, including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics with coadministration.
- Cholestyramine and Colestipol: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
- Lithium: Increased lithium concentrations and lithium toxicity have been reported during concomitant administration of hydrochlorothiazide.
- Antidiabetic Drugs (oral agents and insulin): Dosage adjustment of antidiabetic may be required when coadministered with hydrochlorothiazide.
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To report Adverse Reactions you may contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For medical inquiries please call 1-855-204-1431 or email [email protected]
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US-IN-2500018 12/2025