Pronunciation:

am-LOE-di-peen BES-i-late, a-tor-va-STAT-in KAL-see-um

Brand Names:

• Caduet

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Calcium Channel Blocker/HMG-COA Reductase Inhibitor Combination

Pharmacologic—

Amlodipine

Chemical—

Amlodipine

Uses of This Medicine:

Amlodipine is used alone or together with other medicines to treat high blood pressure. High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is also used to relieve chronic stable angina (chest pain) or vasospastic angina (Prinzmetal's or variant angina). This medicine is also used to lower the risk of hospitalization for angina and heart surgery (eg, coronary revascularization) in patients with recently documented coronary artery disease (CAD) by angiography and without certain heart problems (eg, heart failure or an ejection fraction less than 40%).

Atorvastatin is used together with a proper diet to lower cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, chest pain, heart attack, or stroke) that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Amlodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure, and increases the supply of blood and oxygen to the heart while reducing its workload.

Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and atorvastatin combination in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine to lower high blood pressure in children younger than 6 years of age or to relieve chest pain in children. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of atorvastatin in children 10 years of age and older. However, safety and efficacy have not been established in children younger than 10 years of age to treat homozygous familial hypercholesterolemia (HoFH) and heterozygous familial hypercholesterolemia (HeFH) and in children to treat other types of high cholesterol.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and atorvastatin combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart problems, or increased risk of muscle problems, which may require caution in patients receiving this medicine. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Colchicine
• Lonafarnib
• Posaconazole
• Ritonavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Asciminib
• Atazanavir
• Avacopan
• Bezafibrate
• Carbamazepine
• Ceftobiprole Medocaril
• Ceritinib
• Ciprofibrate
• Ciprofloxacin
• Clarithromycin
• Clofibrate
• Clonidine
• Clopidogrel
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dalfopristin
• Danazol
• Dantrolene
• Daptomycin
• Darolutamide
• Darunavir
• Digoxin
• Diltiazem
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Elafibranor
• Elbasvir
• Elexacaftor
• Eltrombopag
• Ensartinib
• Epirubicin
• Erythromycin
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosamprenavir
• Fosnetupitant
• Fusidic Acid
• Gemfibrozil
• Glecaprevir
• Grazoprevir
• Indinavir
• Isavuconazonium Sulfate
• Itraconazole
• Ketoconazole
• Lacosamide
• Landiolol
• Ledipasvir
• Lefamulin
• Leflunomide
• Leniolisib
• Letermovir
• Levofloxacin
• Levoketoconazole
• Lopinavir
• Mavorixafor
• Melphalan
• Mibefradil
• Midostaurin
• Morphine
• Morphine Sulfate Liposome
• Nefazodone
• Nelfinavir
• Netupitant
• Niacin
• Nirmatrelvir
• Omaveloxolone
• Palbociclib
• Phenobarbital
• Pibrentasvir
• Piperaquine
• Ponesimod
• Primidone
• Quinupristin
• Relugolix
• Repotrectinib
• Resmetirom
• Rifampin
• Ritlecitinib
• Ritonavir
• Saquinavir
• Simeprevir
• Simvastatin
• Tacrolimus
• Tazemetostat
• Tegafur
• Telaprevir
• Telithromycin
• Tenofovir Alafenamide
• Teriflunomide
• Tipranavir
• Tocilizumab
• Trofinetide
• Troleandomycin
• Venetoclax
• Verapamil
• Voclosporin
• Voriconazole
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amprenavir
• Aprepitant
• Azithromycin
• Bexarotene
• Black Cohosh
• Boceprevir
• Bosentan
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Clopidogrel
• Cobicistat
• Crizotinib
• Diltiazem
• Dronedarone
• Duvelisib
• Efavirenz
• Ethinyl Estradiol
• Etravirine
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosphenytoin
• Fostemsavir
• Idelalisib
• Indinavir
• Interferon Beta
• Letermovir
• Lonafarnib
• Mavacamten
• Mifepristone
• Nefazodone
• Nelfinavir
• Nilotinib
• Norethindrone
• Oat Bran
• Pectin
• Phenytoin
• Pioglitazone
• Posaconazole
• Quinine
• Ribociclib
• Rifampin
• Rifapentine
• Saquinavir
• Schisandra sphenanthera
• St John's Wort
• Telithromycin
• Troleandomycin
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol use disorder, or history of or
• Aortic stenosis (heart valve problem), severe or
• Diabetes or
• Heart or blood vessel disease or
• Hypothyroidism (an underactive thyroid) or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Angina (chest pain) or
• Heart attack, acute or
• Heart or blood vessel disease (eg, coronary artery disease) or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Convulsions (seizures), not well-controlled or
• Electrolyte disorders or
• Endocrine disorders, severe or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Major surgery or trauma, recent or
• Metabolic disorders, severe or
• Sepsis (severe infection)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Liver disease (eg, acute liver failure, decompensated cirrhosis)—Should not be used in patients with these conditions.

• Liver disease (eg, chronic alcoholic liver disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Stroke, recent or
• Transient ischemic attack (TIA), recent—Atorvastatin may increase chance of having hemorrhagic stroke (stroke caused by bleeding in the brain).

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of the medicine, treatment for your high blood pressure may include weight control and a change in the types of food you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the tablet whole. Do not break, crush, or chew it. Take this medicine with or without food.

This medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

Do not drink large amounts of alcohol with atorvastatin. This could cause unwanted effects on the liver.

Tell your doctor if you drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1.2 liters each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For angina, high blood pressure, coronary artery disease, and high cholesterol:
    • Adults—1 tablet once a day, tablet strength is determined by your doctor depending on your condition.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take this medicine if it has been more than 12 hours since you missed your last dose. Skip the missed dose and take the next dose at your regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly to lower your cholesterol and triglyceride levels and blood pressure, and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you have a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of a liver problem.

This medicine may cause worsening of angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up suddenly from a lying or sitting position. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause your chest pain or high blood pressure to come back or get worse. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Rare

Chest pain or discomfort

dilated neck veins

extra heartbeats

irregular breathing

irregular heartbeat or pulse

swelling of the face, fingers, feet, or lower legs

weight gain

Incidence not known

Blistering, peeling, or loosening of the skin

chills

dark-colored urine

diarrhea

fever

joint or muscle pain

muscle cramps, spasms, or stiffness

red, irritated eyes

red skin lesions, often with a purple center

sore throat

sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

difficulty with moving

headache

lower back or side pain

pain or tenderness around the eyes and cheekbones

painful or difficult urination

runny or stuffy nose

tender, swollen glands in the neck

voice changes

Less common

Accidental injury

acid or sour stomach

belching

bloated or full feeling

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

general feeling of discomfort or illness

heartburn

indigestion

lack or loss of strength

loss of appetite

nausea

passing gas

shivering

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

trouble sleeping

vomiting

Rare

Anxiety

bad, unusual, or unpleasant (after) taste

blistering, crusting, irritation, itching, or reddening of the skin

burning feeling in the chest or stomach

burning while urinating

change in near or distance vision

change in taste

change in the color of the skin

cold and clammy skin

cracked, dry, scaly skin

difficulty in focusing eyes

dry mouth

dryness of the eyes

excessive muscle tone

frequent urination

hair loss or thinning of the hair

increased appetite

increased volume of pale, dilute urine

irritability

lack of feeling or emotion

loose stools

loss of memory

muscle tension, tightness, or weakness

problems with memory

restlessness

severe and throbbing headache

shakiness and unsteady walk

sneezing

tenderness in the stomach area

transient, mild, or pleasant aromatic odor

trembling, or other problems with muscle control or coordination

twitching

uncaring

unsteadiness

welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.