IRBESARTAN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aurobindo Pharma Limited

INN (שם בינלאומי):

IRBESARTAN

הרכב:

IRBESARTAN 75 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 wi

leaflet_short:

Irbesartan Tablets USP, 75 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T31’ on one side and plain on other side.                         Bottles of 30                           NDC 65862-637-30                         Bottles of 90                           NDC 65862-637-90                         Bottles of 500                         NDC 65862-637-05                         10 x 10 Unit-dose Tablets       NDC 65862-637-78 Irbesartan Tablets USP, 150 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T32’ on one side and plain on other side.                                     Bottles of 30                           NDC 65862-638-30                         Bottles of 90                           NDC 65862-638-90                         Bottles of 500                         NDC 65862-638-05                         10 x 10 Unit-dose Tablets       NDC 65862-638-78 Irbesartan Tablets USP, 300 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T33’ on one side and plain on other side.                         Bottles of 30                           NDC 65862-639-30                         Bottles of 90                           NDC 65862-639-90                         Bottles of 500                         NDC 65862-639-05                        10 x 10 Unit-dose Tablets      NDC 65862-639-78 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

IRBESARTAN - IRBESARTAN TABLET
AUROBINDO PHARMA 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 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 tablets 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 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 AUROBINDO PHARMA USA,
INC. AT 1-866-
850-2876 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Lithium: Risk of lithium toxicity. (7)
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors:
Increased risk of renal
impairm