Amlodipine / Valsartan / Hydrochlorothiazide

What it is and how it works

Mechanism of Action The active ingredients of amlodipine, valsartan and hydrochlorothiazide tablets target 3 separate mechanisms involved in blood pressure regulation. Specifically, amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; valsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume. A more detailed description of the mechanism of action of each individual component follows.

Mechanism class: Angiotensin 2 Receptor Antagonists

Indications

Amlodipine, 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 amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, 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 1 drug to achieve blood pressure goals.

Dosage and administration (summary)

• Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg • Amlodipine, valsartan and hydrochlorothiazide tablets may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics . • Amlodipine, valsartan and hydrochlorothiazide tablets may be substituted for its individually titrated components General Considerations Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine, valsartan and hydrochlorothiazide tablets.

Contraindications

Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. Do not coadminister aliskiren with amlodipine, valsartan and hydrochlorothiazide tablets in patients with diabetes . • Anuria • Hypersensitivity to sulfonamide-derived drugs • Known hypersensitivity to any component • Do not coadminister aliskiren with amlodipine, valsartan and hydrochlorothiazide tablets in patients with diabetes

Warnings and precautions

• Hypotension: Correct volume depletion prior to initiation • Increased angina and/or myocardial infarction • Monitor renal function and potassium in susceptible patients ( 5.4 , 5.5 ) • Exacerbation or activation of systemic lupus erythematosus • Observe for signs of fluid or electrolyte imbalance • Acute angle-closure glaucoma Fetal Toxicity Valsartan Amlodipine, valsartan and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman.

Pregnancy

Pregnancy Risk Summary Amlodipine, valsartan and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the reninangiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Storage and supply

Amlodipine, valsartan and hydrochlorothiazide tablets, USP are available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, …

Source: Amlodipine,Valsartan And Hydrochlorothiazide (Amlodipine,Valsartan And Hydrochlorothiazide) — US FDA prescribing information, 2025-01-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.