RX ITEM-Avapro 75mg Tab 30 by Aventis Pharma

AVAPRO- irbesartan tablet
sanofi-aventis U.S. LLC

WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue AVAPRO as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus


DESCRIPTION
AVAPRO (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan is non-peptide compound, chemically described as 2-butyl-3-[p -(o -1H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its empirical formula is C25 H28 N6 O,
Mechanism of Action
Angiotensin II is potent vasoconstrictor formed from angiotensin in reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis
INDICATIONS AND USAGE
1.1 Hypertension
AVAPRO? 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 wide variety of pharmacologic classes including this drug.
1.2 Nephropathy in Type Diabetic Patients
AVAPRO is indicated for the treatment of diabetic nephropathy in patients with type diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation)
DOSAGE AND ADMINISTRATION
2.1 General Considerations
AVAPRO may be administered with other antihypertensive agents and with or without food.
2.2 Hypertension
The recommended initial dose of AVAPRO is 150 mg once daily. The dosage can be increased to maximum dose of 300 mg once daily as needed to control blood pressure.
2.3 Nephropathy in Type Diabetic Patients
The recommended dose is 300 mg once daily
Dose Adjustment in Volume- and Salt-Depleted Patients
The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis)
DOSAGE FORMS AND STRENGTHS
AVAPRO 75 mg is white to off-white biconvex oval tablet debossed with heart on one side and ?2871? on the other.
AVAPRO 150 mg is white to off-white biconvex oval tablet debossed with heart on one side and ?2872? on the other.
AVAPRO 300 mg is white to off-white biconvex oval tablet debossed with heart on one side and ?2873? on the other.
CONTRAINDICATIONS
AVAPRO is contraindicated in patients who are hypersensitive to any component of this product.
Do not co-administrate aliskiren with AVAPRO in patients with diabetes.
Pregnancy
Pregnancy Category D
PATIENT COUNSELING info.
Pregnancy
Advise female patients of childbearing age about the consequences of exposure to AVAPRO during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Potassium Supplements
Advise patients receiving AVAPRO not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider

Avapro 75mg Tab 30 by Aventis Pharma
NDC No.00024-5850-30 UPC/GTIN No.3-00245-85030-4 MPN 585030 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapi

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Aventis Pharmaceuticals

IRBESARTAN ORAL TABLET 75
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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