Lipitor (Page 10 of 10)

16 HOW SUPPLIED/STORAGE AND HANDLING

10 mg tablets (10 mg of atorvastatin): coded “PD 155″ on one side and “10″ on the other.

NDC 55289-870-30 bottles of 30

Storage

Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP].

17 PATIENT COUNSELING INFORMATION

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

Patients taking LIPITOR 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 LIPITOR.

17.1 Muscle Pain

All patients starting therapy with LIPITOR 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 LIPITOR. 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 LIPITOR and if signs or symptoms of liver injury occur. All patients treated with LIPITOR 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 LIPITOR [see Contraindications (4) and Use in Specific Populations (8.2)].

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0021-35.0

PATIENT INFORMATION

LIPITOR ®
atorvastatin calcium
tablets

(LIP-ih-tore))

Read the Patient Information that comes with LIPITOR 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 LIPITOR, ask your doctor or pharmacist.

What is LIPITOR?

LIPITOR is a prescription medicine 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. LIPITOR is for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.

LIPITOR 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.

LIPITOR 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.

LIPITOR 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 LIPITOR?

Do not take LIPITOR if you:

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

LIPITOR dosing has not been established in children under 10 years of age.

Before You Start LIPITOR

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 LIPITOR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. LIPITOR 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 LIPITOR?

  • Take LIPITOR exactly as prescribed by your doctor. Do not change your dose or stop LIPITOR without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with LIPITOR. Your dose of LIPITOR may be changed based on these blood test results.
  • Take LIPITOR each day at any time of day at about the same time each day. LIPITOR can be taken with or without food.
    Don’t break LIPITOR tablets before taking.
  • Your doctor should start you on a low-fat diet before giving you LIPITOR. Stay on this low-fat diet when you take LIPITOR.
  • If you miss a dose of LIPITOR, take it as soon as you remember. Do not take LIPITOR 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 LIPITOR at the same time.
  • If you take too much LIPITOR or overdose, call your doctor or Poison Control Center right away. Or go to the nearest emergency room.

What Should I Avoid While Taking LIPITOR?

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

What are the Possible Side Effects of LIPITOR?

LIPITOR 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 LIPITOR is stopped. These serious side effects include:

  • Muscle problems. LIPITOR 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 LIPITOR.
  • Liver problems. Your doctor should do blood tests to check your liver before you start taking LIPITOR and if you have symptoms of liver problems while you take LIPITOR. 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 LIPITOR. 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 LIPITOR: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.

The following additional side effects have been reported with LIPITOR:

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 LIPITOR. Ask your doctor or pharmacist for a complete list.

How do I store LIPITOR

  • Store LIPITOR at room temperature, 68 to 77°F (20 to 25°C).
  • Do not keep medicine that is out of date or that you no longer need.
  • Keep LIPITOR 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 LIPITOR

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

This leaflet summarizes the most important information about LIPITOR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LIPITOR that is written for health professionals. Or you can go to the LIPITOR website at www.lipitor.com.

What are the Ingredients in LIPITOR?

Active Ingredient: atorvastatin calcium

Inactive Ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.

LAB-0348-10.0
April 2019

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

Lipitor ®
(atorvastatin calcium) tablets

10 mg*

Rx only

55289870 Label
(click image for full-size original)
LIPITOR atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-870(NDC:0071-0155)
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
CALCIUM CARBONATE
CANDELILLA WAX
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape OVAL (elliptical) Size 10mm
Flavor Imprint Code PD;155;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-870-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020702 12/17/1996
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-870)

Revised: 08/2019 PD-Rx Pharmaceuticals, Inc.

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