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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Medical Information

AVAPRO DOSAGE

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AVAPRO may be administered with other antihypertensive agents and with or without food.1

The recommended initial dose of AVAPRO is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure.1

The recommended dose is 300 mg once daily.1

The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis). Symptomatic hypotension may occur after initialization of treatment with AVAPRO in volume or salt-depleted patients. Correct volume or salt depletion prior to administration of AVAPRO.1

AVAPRO 75 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and ″2871″ on the other.1

AVAPRO 150 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and ″2872″ on the other.1

AVAPRO 300 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and ″2873″ on the other.1

AVALIDE DOSAGE

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The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter.2

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.2

AVALIDE may be administered with or without food.2

AVALIDE may be administered with other antihypertensive agents.2

Renal Impairment

The usual regimens of therapy with AVALIDE may be followed as long as the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so AVALIDE is not recommended.2

Hepatic Impairment

No dosage adjustment is necessary in patients with hepatic impairment.2

In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of AVALIDE, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg.2

AVALIDE may be substituted for the titrated components.2

The usual starting dose is AVALIDE 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion. Volume- or sodium-depletion, should be corrected prior to administration of antihypertensive therapy.

AVALIDE® (irbesartan-hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg film-coated is peach, biconvex, and oval with a heart debossed on one side and ″2875″ or ″2876″ on the reverse side, respectively.2

AVAILABLE AUTHORIZED GENERIC

Learn more about the Irbesartan-Authorized Generics

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References

1. AVAPRO [prescribing information]. Bridgewater, NJ: sanofi-aventis; 2018.

2. AVALIDE [prescribing information]. Bridgewater, NJ: sanofi-aventis; 2018.

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.

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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-2006915-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.