Valsartan

What it is and how it works

Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

Mechanism class: Angiotensin 2 Receptor Antagonists

Indications

Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions • Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults • Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs.

Dosage and administration (summary)

Indication Starting Dose Dose Range* Hypertension Adults 80 -160 mg once daily 80-320 mg once daily 6-16 years 1 mg/kg once daily Up to 40 mg daily 1-4 mg/kg once daily Up to 160 mg daily Heart Failure 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction 20 mg twice daily 20-160 mg twice daily * As tolerated by patient Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets .

Contraindications

Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes . Known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes

Warnings and precautions

. Observe for signs and symptoms of hypotension . Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) Fetal Toxicity Valsartan can cause fetal harm when administered to a pregnant woman. 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.

Pregnancy

Pregnancy Risk Summary Valsartan tablets can cause fetal harm when administered to a pregnant woman. 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.

Storage and supply

Valsartan is available as tablets containing valsartan USP 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. 40 mg tablets are oval, biconvex and scored on one side. 80 mg, 160 mg, and 320 mg tablets are biconvex, oval-shaped and unscored.

Source: Valsartan (Valsartan) — US FDA prescribing information, 2026-08-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.