IRBESARTAN tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Irbesartan tablets  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 variety of pharmacologic classes and with diff

Product samenvatting:

NDC: 71335-1263-1: 30 Tablets in a BOTTLE NDC: 71335-1263-2: 60 Tablets in a BOTTLE NDC: 71335-1263-3: 90 Tablets in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

IRBESARTAN- IRBESARTAN TABLET
BRYANT RANCH PREPACK
----------
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 TABLETS AS SOON
AS POSSIBLE.
(5.1, 8.1)
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. (5.1, 8.1)
INDICATIONS AND USAGE
Irbesartan 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)
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
Hypertension (2.2)
150 mg 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 MACLEODS PHARMA USA,
INC. AT 1-888-
943-3210 OR 1-855-926-3384 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
• Lithium: Risk of lithium toxicity. (7)
• Nonsteroidal Anti-inflammatory Drugs (NSA