AMLODIPINE AND ATORVASTATIN

Other

Brand names: Amlodipine and Atorvastatin

Oral

Mechanism of Action

12.1 Mechanism of Action Amlodipine and atorvastatin tablets are 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 tablets inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The atorvastatin component of amlodipine and atorvastatin tablets 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. 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 vasc

Indications

to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events

including

as appropriate

lipid control

diabetes management

antithrombotic therapy

Contraindications

• 4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )]. Hypersensitivity to amlodipine
• atorvastatin or any excipients in amlodipine and atorvastatin tablets. Hypersensitivity reactions
• including anaphylaxis
• angioneurotic edema
• erythema multiforme

FDA Warnings

5 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 tablets dosage
Temporarily discontinue amlodipine and atorvastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing amlodipine and atorvastatin tablets dosage
Rare reports of fatal and non-fatal hepatic failure have occurred

Known Side Effects

12 documented side effects by frequency

Fatigue

1-10%

Diarrhea

1-10%

Nausea

1-10%

Shortness of Breath

1-10%

Drug Not Working

1-10%

Dizziness

1-10%

Headache

1-10%

Weakness

1-10%

Falls

1-10%

Vomiting

1-10%

High Blood Pressure

1-10%

General Unwellness

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral