Avapro 300 mg/1

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

No Recall History

Plain English

Avapro is a tablet, film coated containing irbesartan at 300 mg/1, taken oral. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: Avapro
Generic Name: irbesartan
NDC Code (Product): 0024-5852
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 300 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020757
Drug Class: 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

fatigue2,503 reports

nausea2,454 reports

diarrhoea2,290 reports

drug ineffective2,155 reports

acute kidney injury2,101 reports

dizziness2,008 reports

dyspnoea2,006 reports

fall1,968 reports

headache1,909 reports

asthenia1,718 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AVAPRO is an angiotensin II receptor blocker (ARB) 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 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension AVAPRO ® 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 this drug. 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. For specific advice on goals and management, see published guidelines, such as those of t…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations AVAPRO may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension 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 [see Clinical Studies (14.1) ] . 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ] . 2.4 Dose Adjustment in Volume and Salt-Depleted Patients 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) [see Warnings and Precautions (5.2) ] .

Contraindications

4 CONTRAINDICATIONS AVAPRO is contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with AVAPRO in patients with diabetes. Hypersensitivity to any component of this product. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity. ( 7 ) Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) 7.1 Agents Increasing Serum Potassium Coadministration of AVAPRO with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) 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 …

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. ( 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. Hypertension AVAPRO has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall…

Frequently Asked Questions

What is Avapro used for?

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

Is Avapro a controlled substance?

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

What is the generic name for Avapro?

The generic name for Avapro is irbesartan. There are 12 other brand versions of irbesartan.

What is the NDC code for Avapro 300 mg/1?

The NDC (National Drug Code) for Avapro 300 mg/1 is 0024-5852, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-5852

Package NDC

0024-5852-30

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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