Pronunciation:

am-LOE-di-peen BES-i-late, a-TORE-va-sta-tin KAL-cee-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 and Atorvastatin is a combination of a calcium channel blocker and HMG-CoA reductase inhibitor. Amlodipine is used to treat angina (chest pain) or high blood pressure. Atorvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. It also helps prevent chest pain, stroke, heart attack, or certain heart and blood vessel diseases in people who are at high risk for these diseases .

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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

The exact way in which this medicine works is not known. Amlodipine is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. Atorvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. The action of both medicines together is to relax blood vessels, lower blood pressure, and decrease the amount of cholesterol in the blood.

Amlodipine and atorvastatin is available only with your doctor's prescription.

Before prescribing the atorvastatin and amlodipine combination for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

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 .

Atorvastatin alone is safe to use in boys and some girls 10 to 17 years of age for treating certain types of high cholesterol.

Adolescent girls taking atorvastatin should be counseled on appropriate contraceptive methods.

Older adults—

Although appropriate studies on the relationship of age to the effects of amlodipine and atorvastatin combination have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of amlodipine and atorvastatin combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving amlodipine and atorvastatin combination .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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—

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.

• Amiodarone
• Atazanavir
• Bezafibrate
• Ciprofibrate
• Clarithromycin
• Clofibrate
• Dalfopristin
• Diltiazem
• Droperidol
• Erythromycin
• Fenofibrate
• Fentanyl
• Fluconazole
• Fusidic Acid
• Gemfibrozil
• Itraconazole
• Ketoconazole
• Mibefradil
• Nefazodone
• Niacin
• Quinupristin
• Telithromycin
• Tipranavir
• Troleandomycin
• Verapamil

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 abuse (or history of) or
• Liver disease (or history of) or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse.

• Aortic stenosis, severe (abnormally narrow aorta)—Use of this medicine may increase the chance of low blood pressure.

• Congestive heart failure—There is a small chance that amlodipine may make this condition worse.

• Convulsions (seizures), not well-controlled, or
• Electrolyte or metabolic enzyme deficiencies or disorders or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma, recent or
• Myopathy (a disorder of muscle tissue or muscles)—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure.

• Coronary artery disease, severe, obstructive—Use of this medicine may result in other heart problems.

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

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered. Also, 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.

Before prescribing the atorvastatin and amlodipine combination for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Follow carefully the special diet your doctor gave you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

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):
  • Adults—1 tablet a day, tablet strength is determined by your doctor.
  • 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.

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 and to change the dosage if needed.

Check with your doctor immediately if you think that you may be pregnant. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not take over-the-counter (OTC) niacin preparations without consulting your doctor. Niacin may increase atorvastatin's adverse effects on muscle, which can lead to serious kidney problems.

Do not use excessive amounts of alcohol while taking atorvastatin because it can worsen the adverse effects of this medicine on the liver.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine's adverse effects on muscle can lead to serious kidney problems.

Checking with physician before discontinuing medication because a gradual reduction in dose may be necessary.

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-Atorvastatin

Cough

difficulty swallowing

dizziness

fast heartbeat

hives

itching

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

shortness of breath

skin rash

tightness in chest

unusual tiredness or weakness

wheezing

Rare-Amlodipine

Chest pain or discomfort

dilated neck veins

extra heartbeats

extreme fatigue

irregular breathing

irregular heartbeat

pulse irregularity

shortness of breath

swelling of face, fingers, feet, or lower legs

weight gain

Observed post-marketing frequency unknown-Atorvastatin

Blistering, peeling, loosening of skin

chills

dark-colored urine

diarrhea

fever

itching

joint or muscle pain

muscle cramps or spasms

muscle pain or stiffness

red irritated eyes

red skin lesions, often with a purple center

sore throat

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

Symptoms of overdose

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

Blurred vision

confusion

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

flushing

sweating

unusual tiredness or weakness

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-Amlodipine

Headache

More common-Atorvastatin

Body aches or pain

congestion

difficulty in moving

dryness or soreness of throat

fever or chills

hoarseness

lower back or side pain

muscle pain or stiffness

pain in joints

pain or tenderness around eyes and cheekbones

painful or difficult urination

runny nose

stuffy nose

tender, swollen glands in neck

voice changes

Less common-Amlodipine

Feeling of warmth

nausea

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

sleepiness or unusual drowsiness

stomach pain

Less common-Atorvastatin

Accidental injury

acid or sour stomach

belching

bloated full feeling

diarrhea

difficulty having a bowel movement (stool)

excess air or gas in stomach or intestines

general feeling of discomfort or illness

heartburn

indigestion

lack or loss of strength

loss of appetite

nausea

passing gas

rash

shivering

stomach discomfort upset or pain

sweating

trouble sleeping

vomiting

Rare-Amlodipine

Anxiety

bad unusual or unpleasant (after) taste

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

burning feeling in chest or stomach

burning while urinating

change in color of skin

change in near or distance vision

change in taste

cold and clammy skin

cracked, dry, scaly skin

difficult or painful urination

difficulty in focusing eyes

dry mouth

dryness of eyes

excessive muscle tone

frequent urination

hair loss, thinning of hair

hives or welts

hyperventilation

increased appetite

increased volume of pale, dilute urine

irritability

lack of feeling or emotion

loose stools

loss of memory

muscle tension or tightness

muscle weakness

nervousness

problems with memory

restlessness

severe and throbbing headache

shakiness and unsteady walk

sneezing

tenderness in stomach area

transient, mild, pleasant aromatic odor

trembling, or other problems with muscle control or coordination

trouble sleeping

twitching

uncaring

unsteadiness

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