Avalide 12.5 mg/1

irbesartan and hydrochlorothiazide · TABLET, FILM COATED · Sanofi-Aventis U.S. LLC

No Recall History

Plain English

Avalide is a tablet, film coated containing irbesartan and hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: Avalide
Generic Name: irbesartan and hydrochlorothiazide
NDC Code (Product): 0024-5856
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 12.5 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020758
Drug Class: Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start: 01/01/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea352 reports

dizziness337 reports

fatigue307 reports

drug ineffective294 reports

dyspnoea246 reports

headache243 reports

blood pressure increased217 reports

diarrhoea215 reports

hypertension200 reports

vomiting192 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AVALIDE ® (irbesartan and 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 hydrochlorothiazide (HCTZ) monotherapy. Th…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION General Considerations Maximum effects within 2 to 4 weeks after dose change. ( 2.1 ) Renal impairment: Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). ( 2.1 , 5.8 ) Hypertension Initiate with 150/12.5 mg. Titrate to 300/12.5 mg then 300/25 mg if needed. ( 2.2 ) Replacement therapy: May be substituted for titrated components. ( 2.3 ) 2.1 General Considerations 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. [See Adverse Reactions (6) .] Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. AVALIDE may be administered with or without food. AVALIDE may be administered with other antihypertensive agents. 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. Hep…

Contraindications

4 CONTRAINDICATIONS AVALIDE is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with AVALIDE in patients with diabetes [see Drug Interactions (7) ] . Hypersensitivity to any component of this product. ( 4 ) Anuria. ( 4 ) Hypersensitivity to sulfonamide-derived drugs. ( 4 ) Do not coadminister aliskiren with AVALIDE in patients with diabetes. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS NSAIDs and selective COX-2 inhibitors: Can reduce diuretic, natriuretic of diuretic, may lead to increased risk of renal impairment and reduced antihypertensive effect. Monitor renal function periodically. ( 7 ) Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and colestipol: Reduced absorption of thiazides. ( 7 ) Lithium: Increases in serum lithium concentrations and lithium toxicity. ( 7 ) Carbamazepine: Increased risk of hyponatremia. ( 7 ) 7.1 Nonsteroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Irbesartan In patients who are elderly, volume depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including irbesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Therefore, monitor renal function and blood pressure periodically in patie…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Irbesartan and Hydrochlorothiazide AVALIDE tablets have been evaluated for safety in 1694 patients treated for essential hypertension in 6 clinical trials. In Studies I through IV with AVALIDE, no adverse events peculiar to this combination drug product have been observed. Adverse events have been limited to those that were reported previously with irbesartan or hydrochlorothiazide (HCTZ). The overall incidence of adverse …

Frequently Asked Questions

What is Avalide used for?

Avalide contains irbesartan and hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Avalide a controlled substance?

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

What is the generic name for Avalide?

The generic name for Avalide is irbesartan and hydrochlorothiazide. There are 11 other brand versions of irbesartan and hydrochlorothiazide.

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

The NDC (National Drug Code) for Avalide 12.5 mg/1 is 0024-5856, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-5856

Package NDC

0024-5856-30

Other Irbesartan Brands

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

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