Amlodipine; Atorvastatin oral tablets

What are Amlodipine; Atorvastatin tablets?

AMLODIPINE; ATORVASTATIN (CADUET®) is a combination of 2 drugs. Amlodipine is a calcium-channel blocker used to lower high blood pressure (hypertension). It also relieves different types of chest pain (angina). Atorvastatin blocks the body's ability to make cholesterol. Atorvastatin can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet. This medicine is not a cure. Generic amlodipine; atorvastatin tablets are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart problems, including heart failure or aortic stenosis

• liver disease

• kidney disease

• an alcohol problem

• any hormone disorder (such as diabetes, under-active thyroid)

• blood salt imbalance

• infection

• low blood pressure

• muscle disorder or condition

• recent surgery

• seizures (convulsions)

• severe injury

• an unusual reaction to Amlodipine; Atorvastatin, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the prescription label. Swallow with a drink of water. You can take it with or without food. Take your doses at regular intervals. Do not take your medicine more often then directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Amlodipine; Atorvastatin?

• alcohol-containing beverages

• antiinflammatory drugs (NSAIDs, such as ibuprofen)

• barbiturates (examples: phenobarbital, butalbital, primidone)

• antacids

• birth control pills

• bosentan

• carbamazepine

• danazol

• digoxin

• herbal or dietary supplements such as ginger, ginkgo biloba, ginseng, hawthorn, ma huang (ephedra), melatonin, St. John's wort, red yeast rice

• imatinib, STI-571

• local anesthetics or general anesthetics

• medicines for fungal infections (examples: fluconazole, itraconazole, ketoconazole, voriconazole)

• medicines for high blood pressure

• medicines for treating HIV infections

• medicines that suppress your immune response (cyclosporine)

• medicines to lower cholesterol or triglycerides (examples: colestipol, fenofibrate, gemfibrozil, niacin)

• medicine used to stop early pregnancy (mifepristone, RU-486 or Mifeprex™)

• medicines for prostate problems

• medicines for seizures (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, zonisamide)

• monoamine oxidase inhibitors (Azilect®, Eldepryl®, Emsam®, Marplan®, Nardil®, Parnate®, Zelapar™)

• nefazodone

• nicardipine

• rifampin, rifabutin, or rifapentine

• pioglitazone

• some antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin)

• some medicines for heart-rhythm problems (amiodarone, diltiazem, verapamil)

• some medicines for depression or mental problems (fluoxetine, fluvoxamine, nefazodone)

• water pills (diuretics)

• yohimbine

• zafirlukast

• zileuton

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Amlodipine; Atorvastatin?

Visit your prescriber or health care professional for regular checks on your progress. You will need to have regular tests to make sure your liver is working properly.

Tell your prescriber or health care professional as soon as you can if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

Amlodipine; atorvastatin contains a cholesterol lowering agent (atorvastatin), but is only part of a total cholesterol-lowering program. Your physician or dietitian can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

Check your blood pressure and pulse rate regularly; this is important while you are taking amlodipine; atorvastatin. Ask your prescriber or health care professional what your blood pressure and pulse rate should be and when you should contact him or her.

You may feel dizzy or lightheaded. Do not drive, use machinery, or do anything that needs mental alertness until you know how amlodipine; atorvastatin affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks; they can make you more dizzy, increase flushing and rapid heartbeats.

Do not suddenly stop taking amlodipine; atorvastatin. Ask your prescriber or health care professional how you can gradually reduce the dose.

If you are going to have surgery, tell your prescriber or health care professional that you are taking amlodipine; atorvastatin.

Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

What side effects may I notice from receiving Amlodipine; Atorvastatin?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

• dark yellow or brown urine

• decreased urination, difficulty passing urine

• fainting spells, dizziness, or lightheadedness

• fever

• irregular heartbeat, chest pain, palpitations

• muscle pain, tenderness, cramps, or weakness

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• skin rash, itching

• swelling of legs or ankles

• unusual tiredness or weakness

• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• diarrhea

• drowsiness

• facial flushing

• gas

• headache

• joint pain

• nausea, vomiting

• stomach upset or pain

• tiredness, weakness or fatigue

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

store at controlled room temperature at 25 degrees C (77 degrees F). Short periods of storage at 15 to 30 degrees C (59 to 86 degrees F) are permitted.