Buy Caduet Online

Caduet (amlodipine besylate/atorvastatin calcium)

THERAPEUTIC CLASS

Calcium channel blocker (CCB)/HMG-CoA reductase inhibitor (statin)

DEA CLASS

RX

INDICATIONS

Amlodipine: Treatment of HTN, alone or in combination w/ other antihypertensive agents. Treatment of chronic stable angina or confirmed or suspected vasospastic (Prinzmetal's/variant) angina, alone or in combination w/ other antianginals. To reduce the risk of hospitalization due to angina and to reduce risk of coronary revascularization procedures in patients w/ recently documented coronary artery disease (CAD) by angiography and w/o heart failure or an ejection fraction <40%. Atorvastatin: To reduce the risk of MI, stroke, revascularization procedures, and angina in adults w/o clinically evident coronary heart disease (CHD), but w/ multiple risk factors for CHD. To reduce the risk of MI and stroke in patients w/ type 2 diabetes, and w/o clinically evident CHD, but w/ multiple risk factors for CHD. To reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients w/ clinically evident CHD. Adjunct to diet for treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types IIa and IIb). Adjunct to diet for treatment of patients w/ elevated serum TG levels (Type IV). Treatment of primary dysbetalipoproteinemia (Type III) inadequately responding to diet. Adjunct to other lipid-lowering treatments or if treatments are unavailable, for treatment of homozygous familial hypercholesterolemia (HoFH). Adjunct to diet for treatment of boys and postmenarchal girls, 10-17 yrs of age, w/ heterozygous familial hypercholesterolemia.

ADULT DOSAGE

Hypertension

Treatment alone or in combination w/ other antihypertensive agents

Amlodipine:
Initial: 5mg qd
Max: 10mg qd

Adjust dose according to BP goals usually waiting 7-14 days between titration steps; titration may proceed more rapidly if clinically warranted

Angina

Chronic stable angina or confirmed or suspected vasospastic (Prinzmetal's/variant) angina, alone or in combination w/ other antianginals

Amlodipine:
5-10mg qd

Coronary Artery Disease

Reduces the risk of hospitalization due to angina and reduces risk of coronary revascularization procedures in patients w/ recently documented coronary artery disease by angiography and w/o heart failure or an ejection fraction <40%

Amlodipine:
5-10mg qd

Hyperlipidemia/Mixed Dyslipidemia

Adjunct to diet for treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types IIa and IIb); adjunct to diet for treatment of patients w/ elevated serum TG levels (Type IV); primary dysbetalipoproteinemia (Type III) inadequately responding to diet; adjunct to other lipid-lowering treatments or if treatments are unavailable, for treatment of homozygous familial hypercholesterolemia

Atorvastatin:
Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types 2a and 2b):

Initial: 10 or 20mg qd; patients who require ≥45% reduction in LDL-C may be started at 40mg qd
Titrate: Analyze lipid levels w/in 2-4 weeks and adjust dose accordingly
Range: 10-80mg qd

Homozygous Familial Hypercholesterolemia:
Range:
10-80mg qd
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis)

Risk Reduction of Myocardial Infarction, Stroke, Cardiovascular Death

Reduces the risk of MI, stroke, revascularization procedures, and angina in adults w/o clinically evident coronary heart disease (CHD), but w/ multiple risk factors for CHD; reduces the risk of MI and stroke in patients w/ type 2 diabetes, and w/o clinically evident CHD, but w/ multiple risk factors for CHD; reduces the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients w/ clinically evident CHD

PEDIATRIC DOSAGE

Hypertension

Treatment alone or in combination w/ other antihypertensive agents

Amlodipine:
6-17 Years:

Usual: 2.5-5mg qd
Max: 5mg qd

Heterozygous Familial Hypercholesterolemia

As an adjunct to diet if after an adequate trial of diet therapy LDL remains ≥190mg/dL or LDL remains ≥160mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or 2 or more other CVD risk factors are present in the pediatric patient

Atorvastatin:
Heterozygous Familial Hypercholesterolemia
:
10-17 Years:
Initial: 10mg/day
Max: 20mg/day
Dose adjustments should be made at intervals of ≥4 weeks

DOSING CONSIDERATIONS

Concomitant Medications
Antihypertensives:
Start w/ 2.5mg qd amlodipine
Cyclosporine or HIV Protease Inhibitors (Tipranavir Plus Ritonavir [RTV]) or Telaprevir: Avoid therapy w/ atorvastatin
Lopinavir Plus RTV: Use lowest necessary dose of atorvastatin
Clarithromycin, Itraconazole, Fosamprenavir, or Combination of Saquinavir/Darunavir/Fosamprenavir Plus RTV: Limit therapy w/ atorvastatin to 20mg and ensure lowest dose needed is employed
Nelfinavir or Boceprevir: Limit therapy w/ atorvastatin to 40mg and ensure lowest dose needed is employed

Hepatic Impairment
Initial: 2.5mg qd amlodipine

Elderly
Initial: 2.5mg qd amlodipine

Other Important Considerations
Small Adults or Fragile Patients:
Initial: 2.5mg qd amlodipine

ADMINISTRATION

Oral route

Take w/ or w/o food

HOW SUPPLIED

Tab: (Amlodipine/Atorvastatin) 2.5mg/10mg, 2.5mg/20mg, 2.5mg/40mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg

CONTRAINDICATIONS

Active liver disease, which may include unexplained persistent elevations in hepatic transaminases, women who are pregnant or may become pregnant, and nursing mothers.

WARNINGS/PRECAUTIONS

Amlodipine: Worsening angina and acute MI may develop after starting or increasing the dose, particularly w/ severe obstructive CAD. Symptomatic hypotension may occur, particularly in patients w/ severe aortic stenosis. Atorvastatin: Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria reported. Increased risk of rhabdomyolysis in patients w/ history of renal impairment; closely monitor for skeletal muscle effects. Myopathy (including immune-mediated necrotizing myopathy [IMNM]) reported; predisposing factor includes advanced age (≥65 yrs of age). D/C if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. Withhold or d/c if an acute, serious condition suggestive of a myopathy occurs or if there is a risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Persistent increases in serum transaminases reported; perform LFTs prior to initiation and repeat as clinically indicated. Fatal and nonfatal hepatic failure (rare) reported; promptly interrupt therapy if serious liver injury w/ clinical symptoms and/or hyperbilirubinemia or jaundice occurs and do not restart if no alternate etiology found. Increases in HbA1c and FPG levels reported. May blunt adrenal and/or gonadal steroid production. Increased risk of hemorrhagic stroke in patients w/ recent stroke or transient ischemic attack (TIA).

ADVERSE REACTIONS

Edema, palpitations, dizziness, fatigue, nasopharyngitis, nausea, insomnia, diarrhea, arthralgia, pain in extremities, UTI, dyspepsia, myalgia, muscle spasms.

DRUG INTERACTIONS

See Dose Modification. Amlodipine: Increased systemic exposure w/ CYP3A inhibitors (moderate and strong) and may require dose reduction; monitor for symptoms of hypotension and edema to determine the need for dose adjustment. Closely monitor BP if coadministered w/ CYP3A inducers. Monitor for hypotension when coadministered w/ sildenafil. May increase systemic exposure of cyclosporine or tacrolimus; monitor trough blood levels of cyclosporine and tacrolimus frequently and adjust dose when appropriate. Atorvastatin: Avoid w/ telaprevir, gemfibrozil, and drugs that decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine). Increased risk of myopathy w/ fibric acid derivatives, erythromycin, lipid-modifying doses of niacin, strong CYP3A4 inhibitors, clarithromycin, combinations of HIV protease inhibitors, and azole antifungals; consider lower initial and maintenance doses. Strong CYP3A4 inhibitors (eg, clarithromycin, several combinations of HIV protease inhibitors, telaprevir, itraconazole, boceprevir) and grapefruit juice may increase levels. CYP3A4 inducers (eg, efavirenz, rifampin) may decrease levels; simultaneous coadministration w/ rifampin recommended. May increase digoxin levels; monitor appropriately. May increase exposure of norethindrone and ethinyl estradiol. Myopathy, including rhabdomyolysis, reported w/ colchicine; use w/ caution. OATP1B1 inhibitors (eg, cyclosporine) may increase bioavailability.

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

Amlodipine: Calcium channel blocker (dihydropyridine); inhibits transmembrane influx of Ca2+ ions into vascular smooth muscle and cardiac muscle. Acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in BP. Atorvastatin: HMG-CoA reductase inhibitor; inhibits conversion of HMG-CoA to mevalonate (precursor of sterols, including cholesterol).

PHARMACOKINETICS

Absorption: Amlodipine: Absolute bioavailability (64-90%); Tmax=6-12 hrs. Atorvastatin: Rapid; absolute bioavailability (14%); Tmax=1-2 hrs. Distribution: Amlodipine: Plasma protein binding (93%). Atorvastatin: Vd=381L; plasma protein binding (≥98%). Metabolism: Amlodipine: Hepatic (extensive). Atorvastatin: CYP3A4 (extensive); ortho- and parahydroxylated derivatives (active metabolites). Elimination: Amlodipine: Urine (10% parent compound; 60% metabolites); T1/2=30-50 hrs. Atorvastatin: Bile (major), urine (<2%); T1/2=14 hrs.

ASSESSMENT

Assess for active liver disease, unexplained and persistent elevations in serum transaminase levels, history of renal impairment, risk factors for developing renal failure secondary to rhabdomyolysis, recent stroke or TIA, hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions. Obtain baseline lipid profile (total-C, LDL, HDL, TG), liver function (eg, AST, ALT) parameters, and BP.

MONITORING

Monitor for signs/symptoms of rhabdomyolysis, myopathy (eg, IMNM), worsening angina, MI, and other adverse reactions. Monitor lipid profile, and CPK levels. Monitor LFTs as clinically indicated, and for increases in HbA1c and FPG levels. Monitor BP.

PATIENT COUNSELING

Advise to adhere to medication, along w/ the National Cholesterol Education Program-recommended diet, a regular exercise program, and periodic fasting lipid panel testing. Inform of the substances that should not be taken concomitantly w/ the drug. Advise patients to inform other healthcare professionals that they are taking the drug. Inform of the risk of myopathy; instruct to report promptly any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, or if muscle signs and symptoms persist after discontinuation. Instruct to report promptly any symptoms that may indicate liver injury. Instruct women of childbearing potential to use effective contraceptive methods to prevent pregnancy and to d/c therapy and contact physician if pregnancy occurs. Instruct not to use the drug if breastfeeding.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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