Warfarin Sodium (Page 8 of 10)

15 REFERENCES

  • Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:160S-198S.
  • Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:454S-545S.
  • Singer DE, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:546S-592S.
  • Becker RC, Meade TW, Berger PB, et al. The primary and secondary prevention of coronary artery disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:776S-814S.
  • Salem DN, O’Gara PT, Madias C, Pauker SG. Valvular and structural heart disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:593S-629S.
  • Monagle P, Chalmers E, Chan A, et al. Antithrombotic therapy in neonates and children. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:887S-968S.

16 HOW SUPPLIED/STORAGE AND HANDLING

Warfarin Sodium Tablets, USP are available containing 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg of warfarin sodium, USP.

The 1 mg tablet is a dark pink round, scored tablet with “WF ” above the score and “1 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8801-01
bottles of 100 tablets

NDC 0378-8801-10
bottles of 1000 tablets

The 2 mg tablet is a lavender round, scored tablet with “WF ” above the score and “2 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8802-01
bottles of 100 tablets

NDC 0378-8802-10
bottles of 1000 tablets

The 2.5 mg tablet is a green round, scored tablet with “WF ” above the score and “2.5 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8825-01
bottles of 100 tablets

NDC 0378-8825-10
bottles of 1000 tablets

The 3 mg tablet is a beige round, scored tablet with “WF ” above the score and “3 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8803-01
bottles of 100 tablets

NDC 0378-8803-10
bottles of 1000 tablets

The 4 mg tablet is a blue round, scored tablet with “WF ” above the score and “4 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8804-01
bottles of 100 tablets

NDC 0378-8804-10
bottles of 1000 tablets

The 5 mg tablet is a peach round, scored tablet with “WF ” above the score and “5 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8805-01
bottles of 100 tablets

NDC 0378-8805-10
bottles of 1000 tablets

The 6 mg tablet is a greenish-blue round, scored tablet with “WF ” above the score and “6 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8806-01
bottles of 100 tablets

NDC 0378-8806-10
bottles of 1000 tablets

The 7.5 mg tablet is a yellow round, scored tablet with “WF ” above the score and “7.5 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8875-01
bottles of 100 tablets

NDC 0378-8875-10
bottles of 1000 tablets

The 10 mg tablet is a white to off-white round, scored tablet with “WF ” above the score and “10 ” below the score on one side and “G ” on the other side. They are available as follows:

NDC 0378-8810-01
bottles of 100 tablets

NDC 0378-8810-10
bottles of 1000 tablets

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

Protect from light.

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

PHARMACIST: Dispense a Medication Guide with each prescription.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

Advise patients to:

  • Tell their physician if they fall often as this may increase their risk for complications.
  • Strictly adhere to the prescribed dosage schedule. Do not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs and botanical (herbal) products except on advice of your physician.
  • Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness or weakness.
  • Contact their doctor
    • immediately if they think they are pregnant
    • to discuss pregnancy planning
    • if they are considering breast-feeding
  • Avoid any activity or sport that may result in traumatic injury.
  • Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy.
  • Carry identification stating that they are taking warfarin sodium tablets.
  • If the prescribed dose of warfarin sodium tablets is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium tablets the next day to make up for missed doses.
  • Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables.
  • Contact their physician to report any serious illness, such as severe diarrhea, infection or fever.
  • Be aware that if therapy with warfarin sodium tablets is discontinued, the anticoagulant effects of warfarin sodium tablets may persist for about 2 to 5 days.

MEDICATION GUIDE
WARFARIN SODIUM TABLETS, USP
(Crystalline)
(war′ far in soe′ dee um)

Read this Medication Guide before you start taking warfarin sodium tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about warfarin sodium tablets when you start taking it and at regular checkups.

What is the most important information I should know about warfarin sodium tablets?

Warfarin sodium tablets can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium tablets are a blood thinner medicine that lowers the chance of blood clots forming in your body.

  • You may have a higher risk of bleeding if you take warfarin sodium tablets and:
    • are 65 years of age or older
    • have a history of stomach or intestinal bleeding
    • have high blood pressure (hypertension)
    • have a history of stroke or “mini-stroke” (transient ischemic attack or TIA)
    • have serious heart disease
    • have a low blood count or cancer
    • have had trauma, such as an accident or surgery
    • have kidney problems
    • take other medicines that increase your risk of bleeding, including:
      • a medicine that contains heparin
      • other medicines to prevent or treat blood clots
      • non-steroidal anti-inflammatory drugs (NSAIDs)
    • take warfarin sodium for a long time. Warfarin sodium is the active ingredient in warfarin sodium tablets.

Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.

Many other medicines can interact with warfarin sodium tablets and affect the dose you need or increase warfarin sodium tablets side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.

Do not take other medicines that contain warfarin sodium while taking warfarin sodium tablets.

  • Get your regular blood test to check for your response to warfarin sodium tablets. This blood test is called an INR test. The INR test checks to see how fast your blood clots. Your healthcare provider will decide what INR numbers are best for you. Your dose of warfarin sodium tablets will be adjusted to keep your INR in a target range for you.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
    • pain, swelling or discomfort
    • headaches, dizziness or weakness
    • unusual bruising (bruises that develop without known cause or grow in size)
    • nosebleeds
    • bleeding gums
    • bleeding from cuts takes a long time to stop
    • menstrual bleeding or vaginal bleeding that is heavier than normal
    • pink or brown urine
    • red or black stools
    • coughing up blood
    • vomiting blood or material that looks like coffee grounds
  • Some foods and beverages can interact with warfarin sodium tablets and affect your treatment and dose.
    • Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of warfarin sodium tablets.
  • Always tell all of your healthcare providers that you take warfarin sodium tablets.
  • Wear or carry information that you take warfarin sodium tablets.

See “What are the possible side effects of warfarin sodium tablets?” for more information about side effects.

What are warfarin sodium tablets?

Warfarin sodium tablets are prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack or other serious conditions if they form in the legs or lungs.

It is not known if warfarin sodium tablets are safe and effective in children.

Who should not take warfarin sodium tablets?

Do not take warfarin sodium tablets if:

  • your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if warfarin sodium tablets are right for you. Talk to your healthcare provider about all of your health conditions.
  • you are pregnant unless you have a mechanical heart valve. Warfarin sodium tablets may cause birth defects, miscarriage or death of your unborn baby.
  • you are allergic to warfarin or any of the other ingredients in warfarin sodium tablets. See the end of this leaflet for a complete list of ingredients in warfarin sodium tablets.

What should I tell my healthcare provider before taking warfarin sodium tablets?

Before you take warfarin sodium tablets, tell your healthcare provider if you:

  • have bleeding problems
  • fall often
  • have liver or kidney problems
  • have high blood pressure
  • have a heart problem called congestive heart failure
  • have diabetes
  • plan to have any surgery or a dental procedure
  • have any other medical conditions
  • are pregnant or plan to become pregnant. See “Who should not take warfarin sodium tablets?”
  • are breast-feeding. You and your healthcare provider should decide if you will take warfarin sodium tablets and breast-feed.

Tell all of your healthcare providers and dentists that you are taking warfarin sodium tablets. They should talk to the healthcare provider who prescribed warfarin sodium tablets for you before you have any surgery or dental procedure. Your warfarin sodium tablets may need to be stopped for a short time or your may need your dose adjusted.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way warfarin sodium tablets work. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about warfarin sodium tablets?”

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take warfarin sodium tablets?

  • Take warfarin sodium tablets exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to warfarin sodium tablets.
  • You must have regular blood tests and visits with your healthcare provider to monitor your condition.
  • If you miss a dose of warfarin sodium tablets, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of warfarin sodium tablets the next day to make up for a missed dose.
  • Call your healthcare provider right away if you:
    • take too much warfarin sodium tablets
    • are sick with diarrhea, an infection or have a fever
    • fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you

What should I avoid while taking warfarin sodium tablets?

  • Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of warfarin sodium tablets?

Warfarin sodium tablets may cause serious side effects including:

  • See “What is the most important information I should know about warfarin sodium tablets?”
    • Death of skin tissue (skin necrosis or gangrene). This can happen soon after starting warfarin sodium tablets. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
    • “Purple toes syndrome.” Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the side effects of warfarin sodium tablets. For more information, ask your healthcare provider or pharmacist.

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

How should I store warfarin sodium tablets?

  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
  • Keep warfarin sodium tablets in a tightly closed container.
  • Protect from light.

Keep warfarin sodium tablets and all medicines out of the reach of children.

General information about warfarin sodium tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use warfarin sodium tablets for a condition for which it was not prescribed. Do not give warfarin sodium tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about warfarin sodium tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about warfarin sodium tablets that is written for healthcare professionals.

If you would like more information, talk to your healthcare provider or call Mylan Pharmaceuticals Inc. toll free at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in warfarin sodium tablets, USP?

Active ingredient: warfarin sodium, USP

Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, stearic acid and,

1 mg tablets: FD&C Red No. 40 Aluminum Lake

2 mg tablets: FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake

2.5 mg tablets: D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake

3 mg tablets: FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake

4 mg tablets: FD&C Blue No. 1 Aluminum Lake

5 mg tablets: FD&C Yellow No. 6 Aluminum Lake

6 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake

7.5 mg tablets: D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake

10 mg tablets: Dye Free

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED DECEMBER 2011
WARF:R3mpbmt/MG:WARF:R2

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