Irbesartan

What it is and how it works

Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a 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 AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

Mechanism class: Angiotensin 2 Receptor Antagonists

Indications

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. • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. . Hypertension 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.

Dosage and administration (summary)

Ind ication D o s e Hypertension 150 to 300 mg once daily Diabetic Nephropathy 300 mg once daily General Considerations Irbesartan Tablets may be administered with other antihypertensive agents and with or without food. Hypertension The recommended initial dose of Irbesartan Tablet is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure . Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily .

Contraindications

Irbesartan Tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not co-administrate aliskiren with Irbesartan Tablets in patients with diabetes. • Hypersensitivity to any component of this product. • Co-administration with aliskiren in patients with diabetes.

Warnings and precautions

• Hypotension: Correct volume or salt depletion prior to administration. • Monitor renal function and serum potassium. Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

Pregnancy

Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Storage and supply

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 100…

Source: Irbesartan (Irbesartan) — US FDA prescribing information, 2022-06-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.