17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Information for Patients
Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, advise patients to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
Advise patients taking atorvastatin that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.
Advise patients about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions (5.1)]. Patients should inform other healthcare professionals prescribing a new medication that they are taking CADUET.
Muscle Pain: Advise patients starting therapy with CADUET of the risk of myopathy and to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing CADUET. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (> 1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.
Liver Enzymes: Advise patients treated with CADUET to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
Embryofetal Toxicity: Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy while using CADUET [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].
(amlodipine and atorvastatin)
Read the patient information that comes with CADUET before you start taking it, and each time you get a refill. There may be new information. This information does not replace talking with your doctor about your condition or treatment. If you have any questions about CADUET, ask your doctor or pharmacist.
CADUET is a prescription drug that combines Norvasc® (amlodipine besylate) and Lipitor® (atorvastatin calcium) in one pill.
CADUET is used in adults who need both Norvasc and Lipitor.
Norvasc is used to treat:
- High blood pressure (hypertension) and
- Chest pain (angina) and
- Blocked arteries of the heart (coronary artery disease)
Lipitor is used to lower the levels of "bad" cholesterol and triglycerides in your blood. It can also raise the levels of "good" cholesterol.
Lipitor is also used to lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as:
- age, smoking, high blood pressure, low levels of "good" cholesterol, heart disease in the family.
Lipitor can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:
- diabetic eye or kidney problems, smoking, or high blood pressure.
CADUET has not been studied in children.
Do not use CADUET if you:
- Are pregnant or think you may be pregnant, or are planning to become pregnant. CADUET may harm your unborn baby. If you get pregnant, stop taking CADUET and call your doctor right away.
- Are breastfeeding. CADUET can pass into your breast milk and may harm your baby. Do not breastfeed if you take CADUET.
- Have liver problems.
- Are allergic to anything in CADUET. The active ingredients are atorvastatin calcium and amlodipine besylate. See the end of this leaflet for a complete list of ingredients.
Tell your doctor about all of your health conditions, including, if you have:
- heart disease
- muscle aches or weakness
- thyroid problems
- kidney problems
- or drink more than 2 glasses of alcohol daily
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. CADUET and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:
You can use nitroglycerin and CADUET together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking CADUET.
Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.
- Take CADUET once a day, exactly as your doctor tells you. Do not change your dose or stop CADUET without talking to your doctor.
- Take CADUET each day at any time of day, at about the same time each day. CADUET can be taken with or without food.
- Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
- Your doctor should start you on a low-fat diet before giving you CADUET. Stay on this low-fat diet when you take CADUET.
- If you miss a dose, take it as soon as you remember. Do not take CADUET if it has been more than 12 hours since your missed dose. Just take the next dose at your regular time. Do not take 2 doses of CADUET at the same time.
- If too much CADUET is taken by accident, call your doctor or poison control center, or go to the nearest emergency room.
- Avoid getting pregnant. If you get pregnant, stop taking CADUET right away and call your doctor.
- Do not breastfeed. CADUET can pass into your breast milk and may harm your baby.
CADUET can cause serious side effects. These side effects happen only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or CADUET is stopped. These serious side effects include:
- Muscle problems. CADUET can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with CADUET.
- Liver problems. Your doctor should do blood tests to check your liver before you start taking CADUET and if you have symptoms of liver problems while you take CADUET. Call your doctor right away if you have the following symptoms of liver problems:
- feel tired or weak
- loss of appetite
- upper belly pain
- dark amber colored urine
- yellowing of your skin or the whites of your eyes
- Low blood pressure or dizziness
- Muscle rigidity, tremor and/or abnormal muscle movement
Call your doctor right away if:
- you have muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a rare muscle problem.
- muscle problems that do not go away even after your doctor has advised you to stop taking CADUET. Your doctor may do further tests to diagnose the cause of your muscle problems.
- allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away
- you have nausea and vomiting, stomach pain
- you are passing brown or dark-colored urine
- you feel more tired than usual
- your skin and white of your eyes get yellow
- you have allergic skin reactions
- Chest pain that does not go away or gets worse. Sometimes when you start CADUET or increase your dose, chest pain can get worse or a heart attack can happen. If this happens, call your doctor or go to the emergency room right away.
Common side effects of CADUET include:
- Swelling of your legs or ankles
- Upset stomach
- Muscle and joint pain
- Alterations in some laboratory blood tests
Additional side effects have been reported: tiredness, tendon problems, memory loss, and confusion.
Talk to your doctor or pharmacist about side effects that bother you or do not go away.
There are other side effects of CADUET. Ask your doctor or pharmacist for a complete list.
- Store CADUET at room temperature, 68 to 77°F (20 to 25°C).
- Do not keep medicine that is out-of-date or that you no longer need.
- Keep CADUET and all medicines out of the reach of children. Keep medicines in places where children cannot get it.
General information about CADUET
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CADUET for a condition for which it was not prescribed. Do not give CADUET to other people, even if they have the same problem you have. It may harm them. This leaflet summarizes the most important information about CADUET. If you want more information, talk with your doctor. Ask your doctor or pharmacist for information about CADUET written for health professionals. You can also go to the CADUET website at www.CADUET.com.
You have high blood pressure when the force of blood against the walls of your arteries stays high. This can damage your heart and other parts of your body. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.
Angina is a pain that keeps coming back when part of your heart does not get enough blood. It feels like something is pressing or squeezing your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaw, or back.
Cholesterol is a fat-like substance made in your body. It is also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol can clog your blood vessels.
A heart attack occurs when heart muscle does not get enough blood. Symptoms include chest pain, trouble breathing, nausea, and weakness. Heart muscle cells may be damaged or die. The heart cannot pump well or may stop beating.
A stroke occurs when nerve cells in the brain do not get enough blood. The cells may be damaged or die. The damaged cells may cause weakness or problems speaking or thinking.
Active ingredients: amlodipine besylate, atorvastatin calcium
Inactive ingredients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium stearate
Film coating: Opadry® II White 85F28751 (polyvinyl alcohol, titanium dioxide, PEG 3000, and talc) or Opadry® II Blue 85F10919 (polyvinyl alcohol, titanium dioxide, PEG 3000, talc, and FD&C blue #2)
Revised December 2020