Atorvastatin Calcium (Page 11 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atorvastatin Calcium Tablets, USP are available containing atorvastatin calcium, USP equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin.

The 10 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 10 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3950-77
bottles of 90 tablets

NDC 0378-3950-05
bottles of 500 tablets

The 20 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 20 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3951-77
bottles of 90 tablets

NDC 0378-3951-05
bottles of 500 tablets

The 40 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 40 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3952-77
bottles of 90 tablets

NDC 0378-3952-05
bottles of 500 tablets

The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 80 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3953-77
bottles of 90 tablets

NDC 0378-3953-05
bottles of 500 tablets

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

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

Patients taking atorvastatin calcium tablets should be advised 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.

Patients should be advised about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium tablets.

17.1 Muscle Pain

All patients starting therapy with atorvastatin calcium tablets should be advised of the risk of myopathy and told 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 atorvastatin calcium tablets. 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.

17.2 Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of atorvastatin calcium tablets and if signs or symptoms of liver injury occur. All patients treated with atorvastatin calcium tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

17.3 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 [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

17.4 Lactation

Advise women not to breastfeed during treatment with atorvastatin calcium tablets [see Contraindications (4) and Use in Specific Populations (8.2)].

The brands listed are trademarks of their respective owners.

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 them 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 medicine that lowers cholesterol in your blood. They lower the LDL-C (“bad” cholesterol) and triglycerides in your blood. They 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 start 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 breastfeeding. Atorvastatin can pass into your breast milk and may harm your baby.
have liver problems.
are allergic to atorvastatin calcium tablets or any of their ingredients. The active ingredient is atorvastatin. See the end of this leaflet for a complete list of ingredients in atorvastatin calcium tablets.

Atorvastatin calcium tablet dosing has 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 2 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
anti-virals

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 2 doses of atorvastatin calcium tablets at the same time.
If you take too many 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.

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, 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 they were not prescribed. Do not give atorvastatin calcium tablets to other people, even if they have the same problem you have. They 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. Or you can call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in atorvastatin calcium tablets?

Active Ingredient: atorvastatin calcium

Inactive Ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India

75076260

Revised: 6/2020
MX:ATOR:R14ppt/MX:PL:ATOR:R10p/MX:PL:ATOR:R10pt

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 0378-3950-77

Atorvastatin
Calcium
Tablets, USP
10 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
atorvastatin calcium, USP
equivalent to 10 mg of atorvastatin.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RM3950MM2

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Atorvastatin Calcium Tablets 10 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 0378-3951-77

Atorvastatin
Calcium
Tablets, USP
20 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
atorvastatin calcium, USP
equivalent to 20 mg of atorvastatin.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RM3951MM3

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Atorvastatin Calcium Tablets 20 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg

NDC 0378-3952-77

Atorvastatin
Calcium
Tablets, USP
40 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
atorvastatin calcium, USP
equivalent to 40 mg of atorvastatin.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RM3952MM2

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Atorvastatin Calcium Tablets 40 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg

NDC 0378-3953-77

Atorvastatin
Calcium
Tablets, USP
80 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
atorvastatin calcium, USP
equivalent to 80 mg of atorvastatin.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RM3953MM2

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Atorvastatin Calcium Tablets 80 mg Bottle Label
(click image for full-size original)
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3950
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SODIUM CARBONATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
ARGININE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3950-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3950-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3950-09 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3950-07 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091226 09/19/2013
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3951
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
ANHYDROUS LACTOSE
SODIUM CARBONATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
ARGININE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3951-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3951-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3951-09 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3951-07 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091226 09/19/2013
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3952
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
ANHYDROUS LACTOSE
SODIUM CARBONATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
ARGININE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3952-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3952-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3952-09 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3952-07 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091226 05/29/2012
ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3953
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SODIUM CARBONATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
ARGININE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code 80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3953-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3953-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3953-09 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3953-07 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091226 09/19/2013
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 06/2020 Mylan Pharmaceuticals Inc.

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