Prescription Drug Information: ATORVASTATIN CALCIUM (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atorvastatin calcium tablets, USP are supplied as white to off-white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.

10 mg tablets

Atorvastatin calcium tablets, USP 10 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side.

NDC 16714-173-01 90 count
NDC 16714-173-02 500 count
NDC 16714-173-03 1000 count

20 mg tablets

Atorvastatin calcium tablets, USP 20 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side.

NDC 16714-174-01 90 count
NDC 16714-174-02 500 count
NDC 16714-174-03 1000 count

40 mg tablets

Atorvastatin calcium tablets, USP 40 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.

NDC 16714-175-01 90 count
NDC 16714-175-02 500 count
NDC 16714-175-03 1000 count

80 mg tablets

Atorvastatin calcium tablets, USP 80 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side.

NDC 16714-176-01 90 count
NDC 16714-176-02 500 count
NDC 16714-176-03 1000 count

Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container [see USP].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Myopathy and Rhabdomyolysis

Advise patients that atorvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), Drug Interactions (7.1)].

Hepatic Dysfunction

Inform patients that atorvastatin calcium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ].

Increases in HbA1c and Fasting Serum Glucose Levels

Inform patients that increases in HbA1c and fasting serum glucose levels may occur with atorvastatin calcium tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4) ].

Pregnancy

Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if atorvastatin calcium tablets should be discontinued [see Use in Specific Populations (8.1) ].

Lactation

Advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium tablets [see Use in Specific Populations (8.2) ].

All registered trademarks in this document are the property of their respective owners.

Manufactured For Manufactured By
Northstar Rx LLC Apotex Inc.
Memphis, TN 38141 Toronto, Ontario
Canada M9L 1T9

Rev. 22

Patient Information

Atorvastatin Calcium Tablets , USP

(a tor″ va stat′ in kal′ see um)

What are atorvastatin calcium tablets?

Atorvastatin calcium tablets are a prescription medicine that contains cholesterol lowering medicine (statin) called atorvastatin.

Atorvastatin calcium tablets are used:

  • to reduce the risk of:
    • heart attack, stroke, certain types of heart surgery and chest pain in adults who do not have heart disease but have other multiple risk factors for heart disease.
    • heart attack and stroke in adults with type 2 diabetes mellitus who do not have heart disease but have other multiple risk factors.
    • heart attack that does not cause death, stroke, certain types of heart surgery, hospitalization for congestive heart failure, and chest pain in adults with heart disease.
  • along with diet to reduce low density lipoprotein cholesterol (LDL-C) or bad cholesterol:
    • in adults with primary hyperlipidemia.
    • in adults and children aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). This is an inherited condition that causes high levels of bad cholesterol.
  • along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). This is an inherited condition that causes high levels of bad cholesterol.
  • along with diet for the treatment of adults with:
    • primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat).
    • hypertriglyceridemia.

It is not known if atorvastatin calcium tablets are safe and effective in children younger than 10 years of age with HeFH or HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH).

Do not take atorvastatin calcium tablets if you:

  • have liver problems (acute liver failure or decompensated cirrhosis)
  • are allergic to atorvastatin or any of the ingredients.in atorvastatin calcium tablets. Stop using atorvastatin calcium tablets and get medical help right away if you have symptoms of a serious allergic reaction including:
    • swelling of your face, lips, tongue or throat
    • problems breathing or swallowing
    • fainting or feeling dizzy
    • very rapid heartbeat
    • severe skin rash or itching
    • flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain

See the end of this leaflet for a complete list of ingredients in atorvastatin calcium tablets.

Before you take atorvastatin calcium tablets, tell your doctor about all of your medical conditions, including if you:

  • have unexplained muscle aches or weakness
  • drink more than 2 glasses of alcohol daily
  • have diabetes
  • have thyroid problems
  • have kidney problems
  • had a stroke
  • are pregnant or plan to become pregnant. Atorvastatin may harm your unborn baby. If you become pregnant, stop taking atorvastatin calcium tablets and call your doctor right away.
  • are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take atorvastatin calcium tablets or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take atorvastatin calcium tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can increase the risk of muscle problem or other side effects. Especially tell your doctor if you take medicines for:

  • your immune system (cyclosporine)
  • cholesterol (gemfibrozil)
  • infections (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole)
  • birth control pills
  • heart failure (digoxin)
  • gout (colchicine)
  • niacin
  • fibrates
  • viruses that treat HIV AIDS, or hepatitis C (anti-virals)
    • tipranavir plus ritonavir
    • glecaprevir plus pibrentasvir
    • ledipasvir plus sofosbuvir
    • simeprevir
    • saquinavir plus ritonavir
    • darunavir plus ritonaviro
    • fosamprenavir
    • fosamprenavir plus ritonavir
    • elbasvir plus grazoprevir
    • letermovir
    • nelfinavir

Ask your doctor or pharmacist for a list of medicines if you are not sure. Know all the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I take atorvastatin calcium tablets?

  • Take atorvastatin calcium tablets exactly as your doctor tells you to take it.
  • 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. Atorvastatin calcium tablets can be taken with or without food.
  • Your doctor should start you on a cholesterol lowering 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 2 doses of atorvastatin calcium tablets at the same time. If you take too much atorvastatin calcium or overdose, call your doctor or Poison Control Center at 1-800-222-1222. or go to the nearest emergency room right away.

What should I avoid while taking atorvastatin calcium tablets?

  • Avoid drinking more than 1.2 liters of grapefruit juice each day.

What are the possible side effects of atorvastatin calcium tablets?

Atorvastatin calcium tablets may cause serious side effects including:

  • Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and, rarely, cause kidney damage that can lead to death. Tell your doctor right away if you have:
    • unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take atorvastatin calcium tablets.
    • muscle problems that do not go away after your doctor has told you to stop taking atorvastatin calcium tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.

    • are taking certain other medicines while you take atorvastatin calcium tablets
    • drink large amounts of grapefruit juice
    • are 65 years of age or older
    • have thyroid problems (hypothyroidism) that are not controlled
    • have kidney problems
    • are taking higher doses of 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
    • nausea or vomiting
    • loss of appetite
    • upper belly pain
    • dark amber colored urine
    • yellowing of your skin or the whites of your eyes
  • Increase in blood sugar level. Your blood sugar level may increase while you are taking atorvastatin calcium tablets. Exercise regularly and make healthy food choices to maintain healthy body weight.

The most common side effects of atorvastatin calcium tablets include:

  • nasal congestion, sore throat, runny nose
  • muscle and joint pain
  • diarrhea
  • pain in extremity
  • urinary tract infection
  • upset stomach
  • nausea
  • musculoskeletal pain
  • muscle spasms
  • trouble sleeping
  • throat pain

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

How do I store atorvastatin calcium tablets ?

  • Store atorvastatin calcium tablets at room temperature, 68°F to 77°F (20°C to 25°C).
  • 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.

General information about the safe and effective use of atorvastatin calcium tablets.

Medicines are sometimes prescribed for purposes other than listed in patient information leaflet. 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 symptoms that you have. It may harm them. If you would like more information about atorvastatin calcium tablets, talk with your doctor. You can ask your pharmacist or doctor for information about atorvastatin calcium tablets that is written for health professionals.

What are the ingredients in atorvastatin calcium tablets?

Active Ingredient: atorvastatin calcium

Inactive Ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.

Manufactured For Manufactured By
Northstar Rx LLC Apotex Inc.
Memphis, TN 38141 Toronto, Ontario
Canada M9L 1T9

Revised: June 2023

Rev. 22

This Patient Package Information has been approved by the U.S. Food and Drug Administration 06/2023

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