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:

Hisun Pharmaceuticals USA Inc.

INN (International Name):

IRBESARTAN

Composition:

IRBESARTAN 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Irbesartan tablets, USP are 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 variet

Product summary:

Irbesartan tablets, USP are available as follows: 75 mg - white to off-white, oval biconvex, film-coated tablets, debossed with HU on one side and 75 on the other side. 150 mg - white to off-white, oval biconvex, film-coated tablets, debossed with HU on one side and 150 on the other side. 300 mg - white to off-white, oval biconvex, film-coated tablets, debossed with HU on one side and 300 on the other side. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN- IRBESARTAN TABLET, FILM COATED
HISUN PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRBESARTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IRBESARTAN TABLETS.
IRBESARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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)
INDICATIONS AND USAGE
Irbesartan tablets, USP are, 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)
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
Hypertension ( 2.2)
150 to 300 mg once daily
Diabetic Nephropathy ( 2.3)300 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, 150 mg, 300 mg ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. ( 4)
Coadministration with aliskiren in patients with diabetes. ( 4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume or salt depletion prior to administration.
( 5.2)
Monitor renal function and serum potassium. ( 5.3)
ADVERSE REACTIONS
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 HISUN PHARMACEUTICALS
USA, INC. AT 1-
855-554-4786 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Lithium: Risk of lithium toxicity ( 7)
Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors:
Inc