INZIRQO 10 mg/mL

hydrochlorothiazide · POWDER, FOR SUSPENSION · ANI Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

INZIRQO is a powder, for suspension containing hydrochlorothiazide at 10 mg/mL, taken oral. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name: INZIRQO
Generic Name: hydrochlorothiazide
NDC Code (Product): 70954-522
Manufacturer: ANI Pharmaceuticals, Inc.
Strength: 10 mg/mL
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: NDA219141
Drug Class: Thiazide Diuretic [EPC]
Marketing Start: 01/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue10,162 reports

nausea9,827 reports

drug ineffective9,467 reports

diarrhoea8,433 reports

pain7,757 reports

dyspnoea7,668 reports

headache7,634 reports

dizziness7,381 reports

arthralgia6,149 reports

off label use5,801 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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, exer…

Dosage & 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: Th…

Contraindications

4 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. Anuria (4) Hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO (4) Hypersensitivity to sulfonamide-derived drugs (4)

Drug Interactions

7 DRUG INTERACTIONS NSAID: May lead to increased risk of renal impairment and loss of diuretic and antihypertensive effect (7.1). Cholestyramine and colestipol: Reduced absorption of thiazides (7.1) Lithium: Increased lithium concentrations and lithium toxicity (7.2) Antidiabetic drugs: Dosage adjustment of antidiabetic may be required (7.2) 7.1 Potential for Other Drugs to Affect INZIRQO Non-Steroidal Anti-Inflammatory Agents: Administration of a nonsteroidal anti-inflammatory agent, including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, when INZIRQO and nonsteroidal anti-inflammatory agents are used concomitantly, check to determine if the desired effect of the diuretic is obtained. Cholestyramine and Colestipol : Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of INZIRQO and the resin such that INZIRQO is administered at least 4 hours before or 4 to 6 hours after the administration of the resin. 7.2 Potential for INZIRQO to Affect Other Drugs Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported duri…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions with INZIRQO are described elsewhere: Impaired Renal Function [see Warnings and Precautions (5.1)] Electrolyte Abnormalities [see Warnings and Precautions (5.2)] Metabolic Disturbances [see Warnings and Precautions (5.3)] Systemic Lupus Erythematosus [see Warnings and Precautions (5.4)] Acute Angle-Closure Glaucoma and Acute Myopia [see Warnings and Precautions (5.5)] Adverse reactions include hypokalemia, hyponatremia, hypomagnesemia, hyperglycemia, hyperuricemia, hyperlipidemia and hypotension. See Adverse Reactions (6) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Gastrointestinal: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritatio…

Frequently Asked Questions

What is INZIRQO used for?

INZIRQO contains hydrochlorothiazide. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is INZIRQO a controlled substance?

INZIRQO is not classified as a controlled substance by the DEA.

What is the generic name for INZIRQO?

The generic name for INZIRQO is hydrochlorothiazide. There are 12 other brand versions of hydrochlorothiazide.

What is the NDC code for INZIRQO 10 mg/mL?

The NDC (National Drug Code) for INZIRQO 10 mg/mL is 70954-522, listed by ANI Pharmaceuticals, Inc..

Product NDC

70954-522

Package NDC

70954-522-10

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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