IRBESARTAN - irbesartan tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

irbesartan (UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)

Available from:

Ajanta Pharma Limited

INN (International Name):

irbesartan

Composition:

irbesartan 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 differe

Product summary:

Irbesartan  tablets USP are available as:   75 mg:   White to  off-white, round, biconvex, uncoated tablets debossed ‘I and 1’ on one side and  plain on other side.   150 mg:  White to off-white,  oval capsule shaped, biconvex, uncoated tablets debossed ‘I and 2’ on one side and plain on other  side.   300 mg:  White to off-white,  oval capsule shaped, biconvex, uncoated tablets debossed ‘I and 3’ on one side  and plain on other side. Unit-of  use bottles contain 30, 90, or 100 tablets as follows:                                     Store at 20°C to 25°C (68°F to 77°F); excursions  permitted to 15°C -30°C (59°F -86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN - IRBESARTAN TABLET
AJANTA PHARMA LIMITED
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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 TABLETS 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 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 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 AJANTA PHARMA USA INC.
AT 855-664-7744 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
antihypert