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Caduet
Generic Name: Amlodipine Besylate/Atorvastatin Calcium
Drug Category: Calcium Channel Blocker/Statin
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.
| Approved Uses |
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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. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. • Coronary Artery Disease (CAD): • Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. • Vasospastic Angina: (Prinzmetal’s or Variant Angina): Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs. • Angiographically Documented CAD: In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin: Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, the atorvastatin component of CADUET can be started simultaneously with diet restriction. • Prevention of Cardiovascular Disease (CVD) in Adults: In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDLC, or a family history of early coronary heart disease, atorvastatin is indicated to
• In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin is indicated to:
• In adult patients with clinically evident coronary heart disease, atorvastatin is indicated to:
• Hyperlipidemia Atorvastatin is indicated:
The safety and effectiveness of CADUET have not been established in pediatric populations. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required. Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). CADUET may be used to provide additional therapy for patients already on one of its components. CADUET may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. Atorvastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. It is recommended that liver enzyme tests be obtained prior to initiating therapy with atorvastatin and repeated as clinically indicated. Postmarketing reports of a possible association between extrapyramidal disorder and amlodipine. Symptomatic hypotension is possible with use of amlodipine, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. The incidence of non-fatal hemorrhagic stroke was significantly higher in the atorvastatin group as compared to the placebo group. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin and with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values > 10 times upper limit of normal [ULN]. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., clarithromycin, itraconazole, and HIV and HCV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including atorvastatin. The risk of myopathy during treatment with statins is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungal. Because of an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, avoid concomitant administration of atorvastatin with gemfibrozil. Avoid a statin with drugs that may decrease the levels or activity of endogenous steroid hormones such as ketoconazole, spironolactone, and cimetidine. In patients taking cyclosporine or the human immunodeficiency virus (HIV) protease inhibitor tipranavir plus ritonavir or the hepatitis C virus (HCV) protease inhibitor glecaprevir plus pibrentasvir, or letermovir when co-administered with cyclosporine, therapy with atorvastatin should be avoided. In patients with HIV taking lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine, use the lowest dose necessary of atorvastatin. In patients taking clarithromycin, itraconazole, elbasvir plus grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, or letermovir therapy with atorvastatin should be limited to 20 mg daily and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is used. In patients taking the HIV protease inhibitor nelfinavir therapy with atorvastatin should be limited to 40 mg daily. Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Monitor for hypotension when sildenafil is co-administered with amlodipine. Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine. Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate. Grapefruit Juice: Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption (> 1.2 liters per day). The risk of skeletal muscle effects may be enhanced when atorvastatin is used in combination with niacin; consider a reduction in atorvastatin dosage in this setting. When multiple doses of atorvastatin and digoxin were co-administered, steady-state plasma digoxin concentrations increased. Co-administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol. Atorvastatin is contraindicated in women who are pregnant or may become pregnant. Because statins have the potential for serious adverse reactions in nursing infants, women taking CADUET should not breastfeed their infants. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Gout. GoToSource • Migraines. GoToSource • Raynaud’s syndrome. GoToSource • Chronic obstructive pulmonary disease and pulmonary hypertension. GoToSource • Scleroderma. GoToSource • Prophylaxis for graft-versus-host disease. GoToSource • Psoriasis. GoToSource • Rheumatoid arthritis. GoToSource • Restoring endothelial function in cigarette smokers. GoToSource • Use seven days before surgery to reduce postoperative atrial fibrillation in patients undergoing elective cardiac surgery with cardiopulmonary bypass. GoToSource • Improve slow coronary flow reserve. GoToSource • Decrease incidence of contrast-induced nephropathy. GoToSource |
| Adverse Events |
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Hemorrhagic stroke. GoToSource Edema (swelling caused by excess fluid) and gingival hyperplasia (enlargement or overgrowth of the gum tissue). GoToSource Telangiectasias (small dilated blood vessels near surface of the skin). GoToSource Cutaneous lymphomatoid drug reactions. GoToSource Delirium. GoToSource Toxic epidermal necrolysis (severe skin disorder). GoToSource New onset diabetes. GoToSource Hepatocellular carcinoma (liver cancer). GoToSource Hypotension (low blood pressure). GoToSource Hyperglycemia (high blood sugar). GoToSource Rhabdomyolysis (destruction of skeletal muscle). GoToSource Myalgia (muscle pain) and myositis (muscle inflammation). GoToSource Hepatotoxicity (liver damage), stevens-johnson syndrome, erythema multiforme (severe skin disorder) and cardiac failure. GoToSource Acute pancreatitis (Inflammation of the pancreas). GoToSource Peripheral neuropathy (damage to or disease affecting nerves) and amyotrophic lateral sclerosis-like syndrome (upper motor neuron lesions). GoToSource Immune-mediated necrotizing myopathy (a type of inflammatory muscle disease). GoToSource Depression. GoToSource |
| Litigation |
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Lawsuits filed for rhabdomyolysis. |
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