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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.

This product is available in the following dosage forms:

• Tablet

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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


• Dantrolene


• Diltiazem


• Droperidol


• Erythromycin


• Fenofibrate


• Fentanyl


• Fluconazole


• Fusidic Acid


• Gemfibrozil


• Itraconazole


• Ketoconazole


• Mibefradil


• Nefazodone


• Niacin


• Quinupristin


• Rituximab


• Telithromycin


• Tipranavir


• Troleandomycin


• Verapamil

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.

• Acebutolol


• Aliskiren


• Alprenolol


• Amprenavir


• Atenolol


• Azithromycin


• Betaxolol


• Bevantolol


• Bisoprolol


• Black Cohosh


• Bosentan


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clopidogrel


• Colchicine


• Conivaptan


• Cyclosporine


• Dalfopristin


• Darunavir


• Digoxin


• Dilevalol


• Efavirenz


• Eltrombopag


• Esmolol


• Etravirine


• Fluconazole


• Fosamprenavir


• Fosphenytoin


• Indinavir


• Itraconazole


• Ketoconazole


• Labetalol


• Levobunolol


• Lopinavir


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Nelfinavir


• Oat Bran


• Oxprenolol


• Pectin


• Penbutolol


• Phenytoin


• Pindolol


• Pioglitazone


• Propranolol


• Quinupristin


• Rifampin


• Rifapentine


• Ritonavir


• Saquinavir


• Sotalol


• St John`s Wort


• Talinolol


• Tertatolol


• Timolol


• Voriconazole

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.

Using this medicine with any of the following may cause an increased risk of certain side effects 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 abuse (or history of) or


• Liver disease (or history of) or


• Liver enzymes, persistently high levelsa€”Use of this medicine may make liver problems worse.

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

• Congestive heart failurea€”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)a€”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, obstructivea€”Use of this medicine may result in other heart problems .

• Stroke, recent or


• Transient ischemic attack (TIA), recenta€”This medicine may increase chance of having hemorrhagic stroke (stroke caused by bleeding in the brain) .

Proper Use

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):
  
  
  
  • Adultsa€”1 tablet a day, tablet strength is determined by your doctor .
  
  
  • Childrena€”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

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

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 .

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