IRBESARTAN- irbesartan tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Camber Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

IRBESARTAN

Composición:

IRBESARTAN 75 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 an

Resumen del producto:

Irbesartan Tablets USP, 75 mg are white to off white, capsule shaped, biconvex tablets, debossed with '158' on one side and 'H' on the other side. They are supplied in Bottles of 30 tablets                         NDC 31722-729-30 Bottles of 90 tablets                         NDC 31722-729-90 Bottles of 500 tablets                       NDC 31722-729-05 Blister Pack of 12x10's (Alu-PVC)   NDC 31722-729-31 Irbesartan Tablets USP, 150 mg are white to off white, capsule shaped, biconvex tablets, debossed with '159' on one side and 'H'  on the other side. They are supplied in Bottles of 30 tablets                           NDC 31722-730-30 Bottles of 90 tablets                           NDC 31722-730-90 Bottles of 500 tablets                         NDC 31722-730-05 Blister Pack of 12x10's (Alu-PVC)     NDC 31722-730-31 Irbesartan Tablets USP, 300 mg are white to off white, capsule shaped, biconvex tablets, debossed with '160' on one side and 'H'  on the other side. They are supplied in Bottles of 30 tablets                          NDC 31722-731-30 Bottles of 90 tablets                          NDC 31722-731-90 Bottles of 500 tablets                        NDC 31722-731-05 Blister Pack of 12x10's (Alu-PVC)     NDC 31722-731-31 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

IRBESARTAN - IRBESARTAN TABLET
CAMBER PHARMACEUTICALS, INC.
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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, 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 tablet 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 HETERO LABS LIMITED AT
1-866-495-1995
OR FDA AT 1-800-FDA-1088 ORWWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
• Lithium: Risk of lithium toxicity ( 7)
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)