IRBESARTAN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Irbesartan 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 the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechan

Product summary:

Irbesartan is available as white to off-white biconvex oval tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain 30, 60 and 90 tablets as follows: Debossing 2871 Bottle of 30 71205-404-30 Bottle of 60 71205-404-60 Bottle of 90 71205-404-90 Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

IRBESARTAN- IRBESARTAN TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRBESARTAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IRBESARTAN.
IRBESARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Irbesartan is an angiotensin II receptor blocker (ARB) indicated for:
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DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
Hypertension (2.2)
150 to 300 mg once daily
Diabetic Nephropathy (2.3)
300 mg once daily
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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.
DRUG INTERACTIONS
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WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AS SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
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)
Tablets: 75 mg, 150 mg, 300 mg (3)
Hypersensitivity to any component of this product. (4)
Coadministration with aliskiren in patients with diabetes. (4)
Hypotension: Correct volume or salt depletion prior to administration.
(5.2)
Monitor renal function and serum potassium. (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)
Lithium: Risk of lithium toxicity. (7)
Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors:
Increased risk of