INDICATIONS AND USAGE

AVAPRO® (irbesartan) is indicated for the treatment of hypertension, to lower blood pressure. Full Indication
AVALIDE® (irbesartan and hydrochlorothiazide) is indicated for the treatment of hypertension. Full Indication

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For US Healthcare Professionals Only
Medical Information

AUTHORIZED GENERIC IS AVAILABLE

Choosing Winthrop US irbesartan or irbesartan-hydrochlorothiazide ensures your patients get the same product as branded AVAPRO or AVALIDE. Irbesartan and irbesartan-hydrochlorothiazide have the same manufacturing process as AVAPRO and AVALIDE. They are identical to AVAPRO and AVALIDE in molecular weight distribution, quality control parameters, and inactive ingredients.1

Affordable Solutions

From the earliest stages of development to batch release, Winthrop US is dedicated to providing affordable solutions to the healthcare community. Irbesartan and irbesartan-hydrochlorothiazide are of the same quality as AVAPRO and AVALIDE along with the cost savings of generics.1

Winthrop US is a Sanofi company dedicated to delivering brand-equal authorized generics of certain Sanofi products, including AVAPRO and AVALIDE.1

Learn More About Winthrop US

See more details about generic Irbesartan or irbesartan-hydrochlorothiazide, as well as the other products Winthrop US has to offer. Learn more about Winthrop, a Sanofi Company.

WHAT ARE AVAPRO AND AVALIDE?

Learn about AVAPRO and AVALIDE for the treatment of hypertension.

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Reference

1. Winthrop US web site. https://www.winthropus.com. Updated March 2018. Accessed September 6, 2019.

INDICATIONS AND USAGE

AVAPRO® (irbesartan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. 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 drug to achieve blood pressure goals. AVAPRO may be used alone or in combination with other antihypertensive agents.

AVAPRO is indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300mg/day).

AVALIDE® (irbesartan and hydrochlorothiazide) is indicated for the treatment of hypertension.

AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.

AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Important Safety Information

WARNING: FETAL TOXICITY

See full Prescribing Information for AVAPRO and AVALIDE for complete Boxed Warnings. When pregnancy is detected, discontinue AVAPRO or AVALIDE as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications

Because of the hydrochlorothiazide component, AVALIDE is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not coadminister aliskiren with AVAPRO or AVALIDE in patients with diabetes.

Warnings and Precautions

Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with AVAPRO or AVALIDE. Correct volume or salt depletion prior to administration of AVAPRO or AVALIDE or use a lower starting dose.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on AVAPRO or AVALIDE. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on AVAPRO or AVALIDE.

Coadministration of AVALIDE with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe.

In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hydrochlorothiazide, a sulfonamide, 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. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Adverse Reactions

The most common adverse reactions for AVAPRO from clinical studies of nephropathy in type 2 diabetic patients were hyperkalemia, dizziness, orthostatic dizziness, and orthostatic hypotension. The most common adverse reactions for AVAPRO from clinical studies in hypertension were diarrhea, dyspepsia/heartburn, and fatigue.

The most common adverse reactions for AVALIDE were dizziness, fatigue, and musculoskeletal pain.

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

Click here for full Prescribing Information, including boxed WARNING for Avapro.

Click here for full Prescribing Information, including boxed WARNING for Avalide.

If you are a patient experiencing problems with a Sanofi US product, please contact Sanofi US at .

The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.

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MAT-US-2006916-v3.0-06/2021 Last Updated: June 2021

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full Prescribing Information for AVAPRO and AVALIDE for complete Boxed Warnings. When pregnancy is detected, discontinue AVAPRO or AVALIDE as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.