Amlodipine / Valsartan

What it is and how it works

Mechanism of Action Amlodipine Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.

Mechanism class: Angiotensin 2 Receptor Antagonists

Indications

Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled on monotherapy • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Hypertension Amlodipine and valsartan tablets, USP 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 and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs.

Dosage and administration (summary)

General Considerations: • Majority of effect attained within 2 weeks • May be administered with other antihypertensive agents Hypertension: • May be used as add-on therapy for patients not controlled on monotherapy • Patients who experience dose-limiting adverse reactions on monotherapy may be switched to amlodipine and valsartan tablets, USP containing a lower dose of that component • May be substituted for titrated components • When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily General Considerations Dose once daily.

Contraindications

Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with amlodipine and valsartan tablets in patients with diabetes . Known hypersensitivity to any component; Do not coadminister aliskiren with amlodipine and valsartan 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 ) Fetal Toxicity Amlodipine and valsartan 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Pregnancy

Pregnancy Risk Summary Amlodipine and valsartan 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

Amlodipin and valartan tablets, USP are available as non-scored tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively) with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.

Source: Amlodipine And Valsartan (Amlodipine And Valsartan) — US FDA prescribing information, 2025-12-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.