Avalide irbesartan and hydrochlorothiazide

Get an overview of AVALIDE (irbesartan and hydrochlorothiazide tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Avalide can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Avalide.

Drug Basics

Brand Name: Avalide

Generic Name: IRBESARTAN AND HYDROCHLOROTHIAZIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2018-10-05

indications & usage

AVALIDE® (irbesartan-hydrochlorothiazide) tablets are 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.

Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.

Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with AVALIDE compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with AVALIDE compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.

avalide 01.jpg
avalide 02.jpg
Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)
For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).
Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)
avalide 03.jpg
avalide 04.jpg
Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)
Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)

The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).

The likelihood of achieving these goals on AVALIDE rises to about 40% (systolic) or 70% (diastolic).

patient counseling information

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to AVALIDE during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physician as soon as possible.

Symptomatic Hypotension

Tell patients using AVALIDE that they may feel lightheaded, especially during the first days of use. Tell patients to inform their physician if they feel lightheaded or faint. Tell the patient, if fainting occurs, stop using AVALIDE and contact the prescribing doctor.

Tell patients using AVALIDE that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.

Potassium Supplements

Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.3)].

Acute Myopia and Secondary Angle-Closure Glaucoma

Advise patients to discontinue AVALIDE and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.8)].

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

© 2018 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 150/12.5 mg Tablet Bottle Label

30 Tablets
NDC 0024-5855-30

Avalide®
(irbesartan-
hydrochlorothiazide)
Tablets
150/12.5 mg

Rx only
SANOFI

avalide 09.jpg

PRINCIPAL DISPLAY PANEL - 300/12.5 mg Tablet Bottle Label

30 Tablets
NDC 0024-5856-30

Avalide®
(irbesartan-
hydrochlorothiazide)
Tablets
300/12.5 mg

Rx only
SANOFI

avalide 10.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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