CADUET®
(amlodipine besylate/atorvastatin calcium) Tablets

CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• 1.Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
• 2.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 or antihypertensive 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 due to angina and to reduce the risk of a coronary revascularization procedure.

AND

• 1.Prevention of Cardiovascular Disease: In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin is indicated to:
  • -Reduce the risk of myocardial infarction
  • -Reduce the risk of stroke
  • -Reduce the risk for revascularization procedures and angina
  
  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, LIPITOR is indicated to:
  • -Reduce the risk of myocardial infarction
  • -Reduce the risk of stroke;
  
  In patients with clinically evident coronary heart disease, LIPITOR is indicated to:
  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina
  
  
• 2.Heterozygous Familial and Nonfamilial Hypercholesterolemia: Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
• 3.Elevated Serum TG Levels: Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
• 4.Primary Dysbetalipoproteinemia: Atorvastatin is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
• 5.Homozygous Familial Hypercholesterolemia: Atorvastatin is indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
• 6.Pediatric Patients: Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
  • LDL-C remains ≥ 190 mg/dL or
  • LDL-C remains ≥ 160 mg/dL and:
    • there is a positive family history of premature cardiovascular disease or
    • two or more other CVD risk factors are present in the pediatric patients.

Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used, in addition to a diet restricted in saturated fat and cholesterol, only when the response to diet and other nonpharmacological measures has been inadequate (see National Cholesterol Education Program (NCEP) Guidelines, summarized in Table 10).

After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

Prior to initiating therapy with atorvastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For patients with TG <400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = total-C - (0.20 × [TG] + HDL-C). For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.

The antidyslipidemic component of CADUET has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:

CADUET contains atorvastatin and is therefore contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.

CADUET is contraindicated in patients with known hypersensitivity to any component of this medication.

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. CADUET, WHICH INCLUDES ATORVASTATIN, SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.

Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.

HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (>3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively.

In clinical trials in patients taking atorvastatin the following has been observed. One patient in clinical trials developed jaundice. Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients, with persistent LFT elevations continued treatment with a reduced dose of atorvastatin.

It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Liver enzyme changes generally occur in the first 3 months of treatment with atorvastatin. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CADUET is recommended.

CADUET should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of CADUET (see CONTRAINDICATIONS).

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with the atorvastatin component of CADUET and with other drugs in the HMG-CoA reductase inhibitor class.

Uncomplicated myalgia has been reported in atorvastatin-treated patients (see ADVERSE REACTIONS). Myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. CADUET therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with drugs in the HMG-CoA reductase inhibitor class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals. Physicians considering combined therapy with CADUET and fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, or lipid-lowering doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

In patients taking CADUET, therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).

Since the vasodilation induced by the amlodipine component of CADUET is gradual in onset, acute hypotension has rarely been reported after oral administration of amlodipine. Nonetheless, caution should be exercised when administering CADUET as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.

Before instituting therapy with CADUET, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems (see INDICATIONS AND USAGE).

In general, calcium channel blockers should be used with caution in patients with heart failure. The amlodipine component of CADUET (5–10 mg per day) has been studied in a placebo-controlled trial of 1153 patients with NYHA Class III or IV heart failure (see CLINICAL PHARMACOLOGY) on stable doses of ACE inhibitor, digoxin, and diuretics. Follow-up was at least 6 months, with a mean of about 14 months. There was no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure). Amlodipine has been compared to placebo in four 8–12 week studies of patients with NYHA class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or LVEF.

The amlodipine component of CADUET is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.

HMG-CoA reductase inhibitors, such as the atorvastatin component of CADUET interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Clinical studies have shown that atorvastatin does not reduce basal plasma cortisol concentration or impair adrenal reserve. The effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Caution should be exercised if an HMG-CoA reductase inhibitor is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.

Due to the risk of myopathy with drugs of the HMG-CoA reductase class, to which the atorvastatin component of CADUET belongs, patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Data from a drug-drug interaction study involving 10 mg of amlodipine and 80 mg of atorvastatin in healthy subjects indicate that the pharmacokinetics of amlodipine are not altered when the drugs are coadministered. The effect of amlodipine on the pharmacokinetics of atorvastatin showed no effect on the Cmax: 91% (90% confidence interval: 80 to 103%), but the AUC of atorvastatin increased by 18% (90% confidence interval: 109 to 127%) in the presence of amlodipine.

No drug interaction studies have been conducted with CADUET and other drugs, although studies have been conducted in the individual amlodipine and atorvastatin components, as described below:

None known.

(see CONTRAINDICATIONS)

Safety in pregnant women has not been established with CADUET. CADUET should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the woman becomes pregnant while taking CADUET, it should be discontinued and the patient advised again as to the potential hazards to the fetus.

No studies have been conducted in pregnant women on the effect of CADUET, amlodipine or atorvastatin on the mother or the fetus during labor or delivery, or on the duration of labor or delivery. Amlodipine has been shown to prolong the duration of labor in rats.

It is not known whether the amlodipine component of CADUET is excreted in human milk. Nursing rat pups taking atorvastatin had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk. Because of the potential for adverse reactions in nursing infants, women taking CADUET should not breast-feed (see CONTRAINDICATIONS).

There have been no studies conducted to determine the safety or effectiveness of CADUET in pediatric populations.

There have been no studies conducted to determine the safety or effectiveness of CADUET in geriatric populations.

CADUET (amlodipine besylate/atorvastatin calcium) has been evaluated for safety in 1092 patients in double-blind placebo controlled studies treated for co-morbid hypertension and dyslipidemia. In general, treatment with CADUET was well tolerated. For the most part, adverse experiences have been mild or moderate in severity. In clinical trials with CADUET, no adverse experiences peculiar to this combination have been observed. Adverse experiences are similar in terms of nature, severity, and frequency to those reported previously with amlodipine and atorvastatin.

The following information is based on the clinical experience with amlodipine and atorvastatin.

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects which occurred in a dose related manner are as follows:

Other adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. In controlled clinical studies of 2502 patients, <2% of patients were discontinued due to adverse experiences attributable to atorvastatin calcium. The most frequent adverse events thought to be related to atorvastatin calcium were constipation, flatulence, dyspepsia, and abdominal pain.

Adverse experiences reported in ≥2% of patients in placebo-controlled clinical studies of atorvastatin, regardless of causality assessment, are shown in Table 12.

There is no information on overdosage with CADUET in humans.

Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg in dogs (11 or more times the maximum recommended clinical dose on a mg/m² basis) caused a marked peripheral vasodilation and hypotension.

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Reports of intentional overdosage include a patient who ingested 250 mg and was asymptomatic and was not hospitalized; another (120 mg) was hospitalized, underwent gastric lavage and remained normotensive; the third (105 mg) was hospitalized and had hypotension (90/50 mmHg) which normalized following plasma expansion. A patient who took 70 mg amlodipine and an unknown quantity of benzodiazepine in a suicide attempt developed shock which was refractory to treatment and died the following day with abnormally high benzodiazepine plasma concentration. A case of accidental drug overdose has been documented in a 19-month-old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm. Ipecac was administered 3.5 hours after ingestion and on subsequent observation (overnight) no sequelae were noted.

If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

There is no specific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

Dosage of CADUET must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia.

The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin.

CADUET may be substituted for its individually titrated components. Patients may be given the equivalent dose of CADUET or a dose of CADUET with increased amounts of amlodipine, atorvastatin or both for additional antianginal effects, blood pressure lowering, or lipid lowering effect.

CADUET may be used to provide additional therapy for patients already on one of its components. As initial therapy for one indication and continuation of treatment of the other, the recommended starting dose of CADUET should be selected based on the continuation of the component being used and the recommended starting dose for the added monotherapy.

CADUET may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. The recommended starting dose of CADUET should be based on the appropriate combination of recommendations for the monotherapies. The maximum dose of the amlodipine component of CADUET is 10 mg once daily. The maximum dose of the atorvastatin component of CADUET is 80 mg once daily.

See above for detailed information related to the dosing and administration of amlodipine and atorvastatin.

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

CADUET tablets are differentiated by tablet color/size and are engraved with "Pfizer" on one side and a unique number on the other side. CADUET tablets are supplied for oral administration in the following strengths and package configurations:

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

(CAD-oo-et)

Read the patient information that comes with CADUET before you start taking it, and each time you get a refill. There may be new information. This information does not replace talking with your doctor about your condition or treatment. If you have any questions about CADUET, ask your doctor or pharmacist.

What is CADUET?

CADUET is a prescription drug that combines Norvasc^® (amlodipine besylate) and Lipitor^® (atorvastatin calcium) in one pill.

CADUET is used in adults who need both Norvasc and Lipitor.

Norvasc is used to treat:

• High blood pressure (hypertension) and
• Chest pain (angina) and
• Blocked arteries of the heart (coronary artery disease)

Lipitor is used to lower the levels of "bad" cholesterol and triglycerides in your blood. It can also raise the levels of "good " cholesterol.

Lipitor is also used to lower the risk for heart attack or stroke in patients who have risk factors for heart disease such as:

• age, smoking, high blood pressure, low HDL-C, heart disease in the family, or
• diabetes with risk factor such as eye problems, kidney problems, smoking, or high blood pressure

CADUET has not been studied in children.

Who should not use CADUET?

Do not use CADUET if you:

• Are pregnant or think you may be pregnant, or are planning to become pregnant. CADUET may harm your unborn baby. If you get pregnant, stop taking CADUET and call your doctor right away.
• Are breastfeeding. CADUET can pass into your breast milk and may harm your baby. Do not breastfeed if you take CADUET.
• Have liver problems.
• Are allergic to anything in CADUET. The active ingredients are atorvastatin calcium and amlodipine besylate. See the end of this leaflet for a complete ul of ingredients.

What should I tell my doctor before taking CADUET?

Tell your doctor about all of your health conditions, including, if you have:

• heart disease
• muscle aches or weakness
• diabetes
• thyroid problems
• kidney problems
• or drink more than 2 glasses of alcohol daily

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. CADUET and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:

• your immune system
• infections
• cholesterol
• birth control
• heart failure
• HIV (AIDS)

You can use nitroglycerin and CADUET together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking CADUET.

Know all the medicines you take. Keep a ul of them with you to show your doctor and pharmacist.

How should I take CADUET?

• Take CADUET once a day, exactly as your doctor tells you. Do not change your dose or stop CADUET without talking to your doctor.
• Take CADUET each day at any time of day, at about the same time each day. CADUET can be taken with or without food.
• Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
• Your doctor should start you on a low-fat diet before giving you CADUET. Stay on this low-fat diet when you take CADUET.
• CADUET comes in many different strengths. Your doctor will test your cholesterol and blood pressure to find the right dose for you.
• If you miss a dose, take it as soon as you remember. Do not take CADUET if it has been more than 12 hours since your missed dose. Just take the next dose at your regular time. Do not take 2 doses of CADUET at the same time.
• If too much CADUET is taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What should I avoid while taking CADUET?

• Avoid getting pregnant. If you get pregnant, stop taking CADUET right away and call your doctor.
• Do not breastfeed. CADUET can pass into your breast milk and may harm your baby.

What are possible side effects of CADUET?

CADUET can cause serious side effects. These side effects happen only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or CADUET is stopped. These serious side effects include:

• Muscle problems. CADUET can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with CADUET.
• Liver problems. CADUET can cause liver problems. Your doctor may do blood tests to check your liver before you start taking CADUET and while you take it.

Call your doctor right away if:

• you have muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual
• you have nausea and vomiting, stomach pain
• you are passing brown or dark-colored urine
• you feel more tired than usual
• your skin and white of your eyes get yellow

• Chest pain that does not go away or gets worse. Sometimes, when you start CADUET or increase your dose, chest pain can get worse or a heart attack can happen. If this happens, call your doctor or go to the emergency room right away.

Common side effects of CADUET include:

• headache
• tiredness
• stomach pain
• gas
• constipation
• swelling of your legs or ankles (edema)
• hot or warm feeling in your face (flushing)
• irregular heartbeat (arrhythmia)
• very fast heartbeat (heart palpitations)
• muscle and joint pain
• dizziness
• extreme sleepiness
• nausea
• rash
• diarrhea

Talk to your doctor or pharmacist about side effects that bother you or do not go away.

There are other side effects of CADUET. Ask your doctor or pharmacist for a complete ul.

How do I store CADUET?

• Store CADUET at room temperature, 68 to 77°F (20 to 25°C).
• Do not keep medicine that is out-of-date or that you no longer need.
• Keep CADUET and all medicines out of the reach of children. Keep medicines in places where children cannot get it.

General information about CADUET

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CADUET for a condition for which it was not prescribed. Do not give CADUET to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about CADUET. If you want more information, talk with your doctor. Ask your doctor or pharmacist for information about CADUET written for health professionals. You can also go to the CADUET website at www.CADUET.com, or call 866-514-0900.

What is high blood pressure (hypertension)?

You have high blood pressure when the force of blood against the walls of your arteries stays high. This can damage your heart and other parts of your body. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

What is angina (chest pain)?

Angina is a pain that keeps coming back when part of your heart does not get enough blood. It feels like something is pressing or squeezing your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaw, or back.

What is cholesterol?

Cholesterol is a fat-like substance made in your body. It is also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol can clog your blood vessels.

What is a heart attack?

A heart attack occurs when heart muscle does not get enough blood. Symptoms include chest pain, trouble breathing, nausea, and weakness. Heart muscle cells may be damaged or die. The heart cannot pump well or may stop beating.

What is a stroke?

A stroke occurs when nerve cells in the brain do not get enough blood. The cells may be damaged or die. The damaged cells may cause weakness or problems speaking or thinking.

WHAT ARE THE INGREDIENTS IN CADUET?

Active ingredients: amlodipine besylate, atorvastatin calcium

Inactive ingredients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium stearate

Film coating: Opadry® II White 85F28751 (polyvinyl alcohol, titanium dioxide, PEG 3000 and talc) or Opadry® II Blue 85F10919 (polyvinyl alcohol, titanium dioxide, PEG 3000, talc, and FD&C blue #2)