IRBESARTAN- irbesartan tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

IRBESARTAN

Composition:

IRBESARTAN 75 mg

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 Tablets, USP 75 mg are white to off white, oval shaped, biconvex tablets debossed with “SG” on one side and “160” on the other side. Bottles of 30           NDC 60429-640-30 Bottles of 90         NDC 60429-640-90 Irbesartan Tablets, USP 150 mg are white to off white, oval shaped, biconvex tablets debossed with “SG” on one side and “161” on the other side. Bottles of 30          NDC 60429-641-30 Bottles of 90       NDC 60429-641-90 Irbesartan Tablets, USP 300 mg are white to off white, oval shaped, biconvex tablets debossed with “SG” on one side and “162” on the other side. Bottles of 30           NDC 60429-642-30 Bottles of 90 NDC 60429-642-90 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN- IRBESARTAN TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
IRBESARTAN TABLETS
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, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
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)
• Co-administration 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 SCIEGEN
PHARMACEUTICALS, INC. AT 1-855-724-3436 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: 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)
USE IN SPECIFIC POPULATIONS
• Nursing Mother