Amlodipine/atorvastatin (By mouth)

Brand Name(s)

Caduet

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is only part of a complete plan for lowering cholesterol and triglycerides in your blood.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using birth control pills, cimetidine (Tagamet®), cyclosporine (Neoral® or Sandimmune®), digoxin (Lanoxin®), erythromycin, spironolactone (Aldactone®), or medicine to treat fungus infections (such as fluconazole, itraconazole, ketoconazole, Diflucan®, Nizoral®, or Sporanox®). Make sure your doctor knows about all other medicines you are using to lower cholesterol or triglycerides, such as gemfibrozil (Lopid®), fenofibrate (Tricor®), or niacin (including vitamin supplements, Niaspan®, or Advicor®).
• Ask your doctor before using an antacid medicine, such as Maalox®, Mylanta®, or Tums®.
• Do not drink alcohol while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash.
• Change in how much or how often you urinate.
• Chest pain (may be related to your disease and not a side effect).
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
• Increased thirst or hunger.
• Lightheadedness, dizziness, or fainting.
• Muscle pain, tenderness, or weakness.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Sudden and severe stomach pain, nausea, or vomiting.
• Swelling in your hands, ankles, or feet.
• Tremors.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, upset stomach, or passing gas.
• Headache.
• Joint pain.
• Warmth or redness in your face, neck, arms, or upper chest.

Introduction

Amlodipine Besylate (am-LOE-di-peen BES-i-late), Atorvastatin Calcium (a-tor-va-STAT-in KAL-see-um)

Treats high blood pressure and angina (chest pain), and lowers high cholesterol levels in your blood. 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. This medicine is a combination of a calcium channel blocker and an HMG-CoA reductase inhibitor (sometimes called a "statin").

Warnings While Using This Medicine

• 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.
• Make sure your doctor knows if you have any kind of heart disease, including congestive heart failure, heart valve problems, or problems with your blood vessels. Tell your doctor if you have recently had a stroke or TIA (transient ischemic attack).
• Make sure your doctor knows if you have a history of liver disease or if you usually drink large amounts of alcohol.
• If your doctor tells you to increase the amount of medicine you are taking or if you are just starting this medicine, make sure you tell the doctor right away if you get muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• 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 major surgery or a major injury. You also may need to stop if you develop other serious health problems, such as seizures or problems with your blood.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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