What Amlodipine Besylate and Atorvastatin Calcium Tablet is used for and how to use it
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Amlodipine Besylate and Atorvastatin Calcium Tablet - Consumer Medicine Information

Manufacture: Dr. Reddy's Laboratories, Inc.
Country: India
Condition: Angina, Coronary Artery Disease, High Blood Pressure (Hypertension), High Cholesterol, Prevention of Cardiovascular Disease
Class: Antihyperlipidemic combinations, Miscellaneous antihypertensive combinations
Form: Tablets
Ingredients: amlodipine besylate, atorvastatin calcium, colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, sodium lauryl sulfate

(from 2.5mg/10mg to 10mg/80mg tablets )

What are Amlodipine Besylate and Atorvastatin Calcium Tablets

Amlodipine besylate and atorvastatin calcium tablets are a prescription drug that combines amlodipine besylate and atorvastatin calcium in one pill.

Amlodipine besylate and atorvastatin calcium tablets are used in adults who need both amlodipine besylate and atorvastatin calcium.

Amlodipine besylate tablets used to treat:

  • High blood pressure (hypertension) and
  • Chest pain (angina) and
  • Blocked arteries of the heart (coronary artery disease)

Atorvastatin calcium tablets are used to lower the levels of “bad” cholesterol and triglycerides in your blood. It can also raise the levels of “good” cholesterol.

Atorvastatin calcium tablets are 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.

Atorvastatin calcium tablets 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.

Amlodipine besylate and atorvastatin calcium tablets has not been studied in children.

Who Should not Use Amlodipine Besylate and Atorvastatin Calcium Tablets

Do not use amlodipine besylate and atorvastatin calcium tablets if you:

  • Are pregnant or think you may be pregnant, or are planning to become pregnant. Amlodipine besylate and atorvastatin calcium tablets may harm your unborn baby. If you get pregnant, stop taking amlodipine besylate and atorvastatin calcium tablets and call your doctor right away.
  • Are breastfeeding. Amlodipine besylate and atorvastatin calcium tablets can pass into your breast milk and may harm your baby. Do not breastfeed if you take amlodipine besylate and atorvastatin calcium tablets.
  • Have liver problems.
  • Are allergic to anything in amlodipine besylate and atorvastatin calcium tablets. The active ingredients are atorvastatin calcium and amlodipine besylate. See the end of this leaflet for a complete list of ingredients.

What Should I Tell my Doctor Before Taking Amlodipine Besylate and Atorvastatin Calcium Tablets

Tell your doctor about all of your health conditions, including, if you have:

  • heart disease
  • muscle aches or
  • weakness diabetes
  • 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. Amlodipine besylate and atorvastatin calcium tablets and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Amlodipine besylate and atorvastatin calcium tablets and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:

  • your immune system
  • birth control
  • infections
  • heart failure
  • cholesterol
  • HIV (AIDS)

You can use nitroglycerin and amlodipine besylate and atorvastatin calcium tablets together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking amlodipine besylate and atorvastatin calcium tablets.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How Should I Take Amlodipine Besylate and Atorvastatin Calcium Tablets

  • Take amlodipine besylate and atorvastatin calcium tablets once a day, exactly as your doctor tells you. Do not change your dose or stop amlodipine besylate and atorvastatin calcium tablets without talking to your doctor.
  • Take amlodipine besylate and atorvastatin calcium tablets each day at any time of day, at about the same time each day. Amlodipine besylate and atorvastatin calcium tablets 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 amlodipine besylate and atorvastatin calcium tablets. Stay on this low-fat diet when you take amlodipine besylate and atorvastatin calcium tablets.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate and atorvastatin calcium tablets 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 amlodipine besylate and atorvastatin calcium tablets at the same time.
  • If too much amlodipine besylate and atorvastatin calcium tablets are taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What Should I Avoid While Taking Amlodipine Besylate and Atorvastatin Calcium Tablets

  • Avoid getting pregnant. If you get pregnant, stop taking amlodipine besylate and atorvastatin calcium tablets right away and call your doctor.
  • Do not breastfeed. Amlodipine besylate and atorvastatin calcium tablets can pass into your breast milk and may harm your baby.

What are Possible Side Effects of Amlodipine Besylate and Atorvastatin Calcium Tablets

Amlodipine besylate and atorvastatin calcium tablets 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 amlodipine besylate and atorvastatin calcium tablets are stopped. These serious side effects include:

  • Muscle problems . Amlodipine besylate and atorvastatin calcium tablets 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 amlodipine besylate and atorvastatin calcium tablets.
  • Liver problems . Your doctor should do blood tests to check your liver before you start taking amlodipine besylate and atorvastatin calcium tablets and if you have symptoms of liver problems while you take amlodipine besylate and atorvastatin calcium tablets. 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 amlodipine besylate and atorvastatin calcium tablets. 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 amlodipine besylate and atorvastatin calcium tablets 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 amlodipine besylate and atorvastatin calcium tablets include:

  • Diarrhea
  • Swelling of your legs or ankles
  • Nausea
  • 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 amlodipine besylate and atorvastatin calcium tablets. Ask your doctor or pharmacist for a complete list.

How do I Store Amlodipine Besylate and Atorvastatin Calcium Tablets

  • Store amlodipine besylate and atorvastatin calcium tablets at room temperature, 20° to 25°C (68° to 77°F)
  • Do not keep medicine that is out-of-date or that you no longer need.
  • Keep amlodipine besylate and atorvastatin calcium tablets and all medicines out of the reach of children. Keep medicines in places where children cannot get it.

General Information About Amlodipine Besylate and Atorvastatin Calcium Tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use amlodipine besylate and atorvastatin calcium tablets for a condition for which it was not prescribed. Do not give amlodipine besylate and atorvastatin calcium tablets to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about amlodipine besylate and atorvastatin calcium tablets. If you want more information, talk with your doctor. Ask your doctor or pharmacist for information about amlodipine besylate and atorvastatin calcium tablets written for health professionals or call 1-888-375-3784.

What is High Blood Pressure (Hypertension)

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.

What is Angina (Chest Pain)

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.

What is Cholesterol

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.

What is a Heart Attack

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.

What is a Stroke

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.

What are the Ingredients in Amlodipine Besylate and Atorvastatin Calcium Tablets

Active Ingredients

Amlodipine besylate USP, atorvastatin calcium.

Inactive Ingredients

Colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, sodium lauryl sulfate.

Film Coating

Opadry- II White 85G18490 (Polyethylene glycol, polyvinyl alcohol, lecithin, talc and titanium dioxide), or Opadry- II Blue 85G50642 (FD&C Blue No.2, polyethylene glycol, polyvinyl alcohol, lecithin, talc and titanium dioxide).

To reorder additional Patient Information Sheets, contact Dr. Reddy’s customer service at 1-866-733-3952.