IRBESARTAN tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Alembic Pharmaceuticals Limited

INN (इंटरनेशनल नाम):

IRBESARTAN

रचना:

IRBESARTAN 75 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 variety of pharmacologic classes and with dif

उत्पाद समीक्षा:

Irbesartan Tablets USP 75 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L131” on one side and “75” on other side. They are supplied as follows: NDC 46708-439-30                Bottles of 30 NDC 46708-439-90                Bottles of 90 NDC 46708-439-31                Bottles of 100 NDC 46708-439-71                Bottles of 500 NDC 46708-439-91                Bottles of 1000 Irbesartan Tablets USP 150 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L132” on one side and “150” on other side. They are supplied as follows: NDC 46708-440-30                Bottles of 30 NDC 46708-440-90                Bottles of 90 NDC 46708-440-31                Bottles of 100 NDC 46708-440-71                Bottles of 500 NDC 46708-440-91                Bottles of 1000 Irbesartan Tablets USP 300 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L133” on one side and “300” on other side. They are supplied as follows: NDC 46708-441-30                Bottles of 30 NDC 46708-441-90                Bottles of 90 NDC 46708-441-31                Bottles of 100 NDC 46708-441-71                Bottles of 500 NDC 46708-441-91                Bottles of 1000 Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

IRBESARTAN - IRBESARTAN TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
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 Tablets USP 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). (1)
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) (3)
CONTRAINDICATIONS
• Hypersensitivity to any component of this product. (4)
• Co-administration with aliskiren in patients with diabetes. (4)
(4)
WARNINGS AND PRECAUTIONS
• Hypotension: Correct volume or salt depletion prior to
administration. (5.2)
• Monitor renal function and serum potassium. (5.3) (5)
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 FDA AT 1-800-FDA-1088
OR
WWW.FDA.GOV/MEDWATCH (6)
DRUG INTERACTIONS
• Lithium: Risk of lithium toxicity (7)
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and COX-2
inhibitors: Increas