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). Also lowers high cholesterol and triglyceride levels. Reduces the risk of angina, stroke, heart attack, or certain heart and blood vessel problems. This medicine contains a calcium channel blocker (CCB) and a statin.

Brand Name(s):

Caduet

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take this medicine if it has been more than 12 hours since you missed your last dose. Skip the missed dose and take the next dose at your regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some foods and medicines can affect how amlodipine/atorvastatin works. Tell your doctor if you are using any of the following:
  • Boceprevir, cimetidine, colchicine, cyclosporine, digoxin, diltiazem, elbasvir/grazoprevir, fenofibrate, gemfibrozil, glecaprevir/pibrentasvir, ledipasvir/sofosbuvir, letermovir, niacin (vitamin B3), rifampin, sildenafil, spironolactone, tacrolimus, telaprevir
  • Birth control pills (including ethinyl estradiol/norethindrone)
  • Medicine to treat an infection (including clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, voriconazole)
  • Medicine to treat HIV/AIDS (including darunavir/ritonavir, efavirenz, fosamprenavir, fosamprenavir/ritonavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir/ritonavir, simeprevir, tipranavir/ritonavir)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, diabetes, an infection, heart or blood vessel disease (including coronary artery disease, aortic stenosis), low blood pressure, muscle pain or weakness, seizures, thyroid problems, a recent stroke or TIA (transient ischemic attack), or a history of liver disease. Tell your doctor if you drink alcohol regularly.
• This medicine may cause the following problems:
  • Severe muscle problems (including myopathy, immune-mediated necrotizing myopathy), especially when used with other medicines
  • Rhabdomyolysis (severe muscle weakness) that could lead to kidney damage, especially when used with other medicines
  • Liver problems
  • Worsening chest pain
  • Increased risk of heart attack
  • Low blood pressure
• This medicine may make you dizzy, drowsy, or lightheaded. Stand or sit up slowly if you feel lightheaded or dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly without asking your doctor, even if you feel well.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, or red skin rash
• Change in how much or how often you urinate, painful urination
• Chest pain that may spread, trouble breathing, unusual sweating
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden, severe headache, problems with vision, speech, or walking, seizures, numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unexplained muscle pain, tenderness, or weakness, fever, tiredness

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

• Diarrhea, upset stomach
• Joint pain
• Stuffy or runny nose, sore throat

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