Prescription Drug Information: Atorvastatin Calcium (Page 8 of 8)

PATIENT INFORMATION

ATORVASTATIN CALCIUM TABLETS, USP

(a tor” va stat’ in kal’ see um)

Read the Patient Information that comes with atorvastatin calcium tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

If you have any questions about atorvastatin calcium tablets, ask your doctor or pharmacist.

What are Atorvastatin Calcium Tablets?

Atorvastatin calcium tablets are a prescription medicines that lowers cholesterol in your blood. It lowers the LDL-C (“bad” cholesterol) and triglycerides in your blood. It can raise your HDL-C (“good” cholesterol) as well. Atorvastatin calcium tablets are for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.

Atorvastatin calcium tablets can 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 HDL-C, 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:

  • eye problems, kidney problems, smoking, or high blood pressure.

Atorvastatin calcium tablets starts to work in about 2 weeks.

What is Cholesterol?

Cholesterol and triglycerides are fats that are made in your body. They are also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol and triglycerides can clog your blood vessels. It is especially important to lower your cholesterol if you have heart disease, smoke, have diabetes or high blood pressure, are older, or if heart disease starts early in your family.

Who Should Not Take Atorvastatin Calcium Tablets?

Do not take atorvastatin calcium tablets if you:

  • are pregnant or think you may be pregnant, or are planning to become pregnant. Atorvastatin calcium tablets may harm your unborn baby. If you get pregnant, stop taking atorvastatin calcium tablets and call your doctor right away.
  • are breast feeding. Atorvastatin calcium can pass into your breast milk and may harm your baby.
  • have liver problems.
  • are allergic to atorvastatin calcium tablets or any of its ingredients. The active ingredient is atorvastatin. See the end of this leaflet for a complete list of ingredients in atorvastatin calcium tablets.

Atorvastatin calcium tablets dosing have not been established in children under 10 years of age.

Before You Start Atorvastatin Calcium Tablets:

Tell your doctor if you:

  • have muscle aches or weakness
  • drink more than two glasses of alcohol daily
  • have diabetes
  • have a thyroid problem
  • have kidney problems

Some medicines should not be taken with atorvastatin calcium tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for:

  • your immune system
  • cholesterol
  • infections
  • birth control
  • heart failure
  • HIV or AIDS
  • hepatitis C virus

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

How Should I Take Atorvastatin Calcium Tablets?

  • Take atorvastatin calcium tablets exactly as prescribed by your doctor. Do not change your dose or stop atorvastatin calcium tablets without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with atorvastatin calcium tablets. Your dose of atorvastatin calcium tablets may be changed based on these blood test results.
  • Take atorvastatin calcium tablets each day at any time of day at about the same time each day. Atorvastatin calcium tablets can be taken with or without food.

Don’t break atorvastatin calcium tablets before taking.

  • Your doctor should start you on a low-fat diet before giving you atorvastatin calcium tablets. Stay on this low-fat diet when you take atorvastatin calcium tablets.
  • If you miss a dose of atorvastatin calcium tablets, take it as soon as you remember. Do not take atorvastatin calcium tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Do not take two doses of atorvastatin calcium at the same time.
  • If you take too much atorvastatin calcium tablets or overdose, call your doctor or Poison Control Center right away. Or go to the nearest emergency room.

What Should I Avoid While Taking Atorvastatin Calcium Tablets?

  • Talk to your doctor before you start any new medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can interact causing serious side effects.
  • Do not get pregnant. If you get pregnant, stop taking atorvastatin calcium tablets right away and call your doctor.

What are the Possible Side Effects of Atorvastatin Calcium Tablets?

Atorvastatin calcium tablets can cause serious side effects. These side effects have happened 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 atorvastatin calcium tablets are stopped. These serious side effects include:

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

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 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.
  • nausea and vomiting.
  • passing brown or dark-colored urine.
  • you feel more tired than usual
  • your skin and whites of your eyes get yellow.
  • stomach pain.
  • allergic skin reactions.

In clinical studies, patients reported the following common side effects while taking atorvastatin calcium tablets: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.

The following additional side effects have been reported with atorvastatin calcium tablets: tiredness, tendon problems, memory loss, and confusion.

Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away.

These are not all the side effects of atorvastatin calcium tablets. Ask your doctor or pharmacist for a complete list.

How do I store Atorvastatin Calcium Tablets?

  • Store atorvastatin calcium tablets at 20° to 25°C (68° to 77°F).
  • Do not keep medicine that is out of date or that you no longer need.
  • Keep atorvastatin calcium tablets and all medicines out of the reach of children. Be sure that if you throw medicine away, it is out of the reach of children.

General Information About Atorvastatin Calcium Tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use atorvastatin calcium tablets for a condition for which it was not prescribed. Do not give 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 atorvastatin calcium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atorvastatin calcium tablets that is written for health professionals.

What are the ingredients in Atorvastatin Calcium Tablets?

Active Ingredient: atorvastatin calcium, USP

Inactive Ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80.

Manufactured by:

Graviti Pharmaceuticals Private Limited.

Telangana-502307, India

Manufactured for:

Biocon Pharma Inc.,

Iselin, NJ 08830-3009 USA

Packaged by:
Legacy Pharmaceutical Packaging, LLC, Earth City, MO 63045

Distributed by: The Kroger Co., Cincinnati, OH 45202

Revised: May 2019

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 20 mg Tablet Bottle Label

NDC 68645-591-54

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

20 mg

Atorvastatin Calcium Tablets, USP 20 mg
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 40 mg Tablet Bottle Label

NDC 68645-592-54

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

40 mg

Atorvastatin Calcium Tablets, USP 40 mg
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-591(NDC:70377-028)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-591-54 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018 06/30/2021
ATORVASTATIN CALCIUM atorvastatin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-592(NDC:70377-029)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68645-592-54 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018 06/30/2021
Labeler — Legacy Pharmaceutical Packaging, LLC (143213275)

Revised: 10/2020 Legacy Pharmaceutical Packaging, LLC

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