HYZAAR 12.5 mg/1

losartan potassium and hydrochlorothiazide · TABLET, FILM COATED · Organon LLC

No Recall History

Plain English

HYZAAR is a tablet, film coated containing losartan potassium and hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by Organon LLC.

Key Facts

Brand Name: HYZAAR
Generic Name: losartan potassium and hydrochlorothiazide
NDC Code (Product): 78206-139
Manufacturer: Organon LLC
Strength: 12.5 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020387
Drug Class: Thiazide Diuretic [EPC]
Marketing Start: 06/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea772 reports

drug ineffective737 reports

fatigue684 reports

dizziness585 reports

headache562 reports

diarrhoea530 reports

pain511 reports

dyspnoea505 reports

arthralgia452 reports

asthenia448 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE HYZAAR is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) 1.1 Hypertension HYZAAR ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide. 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 1 dru…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Hypertension Usual starting dose: 50/12.5 mg once daily. ( 2.1 ) Titrate as needed to a maximum dose of 100/25 mg. ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as needed to a maximum of 100/25 mg. ( 2.2 ) 2.1 Hypertension The usual starting dose of HYZAAR is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see Clinical Studies (14.2) ] . Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with HYZAAR 50/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 once daily. Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with HYZAAR 100/12.5 (losartan 100 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of th…

Contraindications

4 CONTRAINDICATIONS HYZAAR is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of HYZAAR. ( 4 ) Anuria. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Agents increasing serum potassium: Risk of hyperkalemia. ( 7.1 ) Lithium: Risk of lithium toxicity. ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) Cholestyramine and colestipol: Reduced absorption of thiazides. ( 7.5 ) 7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving HYZAAR and lithium. 7.3 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors Losartan Potassium In patients who are elderly, volume-depleted (including those on diuretic therapy), or with …

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Losartan potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively. In these double-blind controlled clinical trials, adverse reactions occurring in…

Frequently Asked Questions

What is HYZAAR used for?

HYZAAR contains losartan potassium and hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is HYZAAR a controlled substance?

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

What is the generic name for HYZAAR?

The generic name for HYZAAR is losartan potassium and hydrochlorothiazide. There are 12 other brand versions of losartan potassium and hydrochlorothiazide.

What is the NDC code for HYZAAR 12.5 mg/1?

The NDC (National Drug Code) for HYZAAR 12.5 mg/1 is 78206-139, listed by Organon LLC.

Product NDC

78206-139

Package NDC

78206-139-01

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

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