Valsartan / Hydrochlorothiazide

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 and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. 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 hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. 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 one drug to achieve blood pressure goals.

Dosage and administration (summary)

Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg. May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ). May be substituted for titrated components. General Considerations The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure . Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Contraindications

Valsartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes . Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component.

Warnings and precautions

Hypotension: Correct volume depletion prior to initiation. Observe for signs of fluid or electrolyte imbalance. Monitor renal function and potassium in susceptible patients. (5.3, 5.7) Exacerbation or activation of systemic lupus erythematosus. Acute angle-closure glaucoma. Fetal Toxicity Valsartan and hydrochlorothiazide 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.

Pregnancy

Pregnancy Risk Summary Valsartan and hydrochlorothiazide 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 and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg are supplied as pink, ovaloid, film-coated unscored tablets debossed with “845” on one side and “AN” on the other side.

Source: Valsartan And Hydrochlorothiazide (Valsartan And Hydrochlorothiazide) — US FDA prescribing information, 2026-01-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.