Amlodipine / Atorvastatin

What it is and how it works

Mechanism of Action Amlodipine and atorvastatin is a combination of two drugs, a dihydropyridine calcium channel blocker (amlodipine) and an HMG-CoA reductase inhibitor (atorvastatin). The amlodipine component of amlodipine and atorvastatin inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The atorvastatin component of amlodipine and atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Amlodipine Amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.

Indications

Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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. 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. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Dosage and administration (summary)

Amlodipine and Atorvastatin Tablets Dosage of amlodipine and atorvastatin tablets must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia. Select doses of amlodipine and atorvastatin independently. Amlodipine and atorvastatin tablets may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine and atorvastatin tablets or a dose of amlodipine and atorvastatin tablets with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, blood pressure lowering, or lipid-lowering effect.

Contraindications

Acute liver failure or decompensated cirrhosis . Hypersensitivity to amlodipine, atorvastatin or any excipients in amlodipine and atorvastatin. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported . • Acute liver failure or decompensated cirrhosis . • Hypersensitivity to amlodipine, atorvastatin or any excipient in amlodipine and atorvastatin tablets .

Warnings and precautions

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher amlodipine and atorvastatin dosage. Discontinue amlodipine and atorvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue amlodipine and atorvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.

Pregnancy

Pregnancy Risk Summary Atorvastatin Discontinue atorvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol.

Storage and supply

Amlodipine and atorvastatin tablets, USP contain amlodipine besylate, USP and atorvastatin calcium, USP equivalent to amlodipine and atorvastatin in the dose strengths described below.

Source: Amlodipine And Atorvastatin (Amlodipine And Atorvastatin) — US FDA prescribing information, 2025-05-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.