Warfarin Sodium (Page 7 of 8)

HOW SUPPLIED

Warfarin sodium tablets USP are available as follows:

1 mg: (dark pink, round, flat-faced, beveled-edged tablets with “WF” scoreline “1″ on one side and “G” on theother side)

bottles of 100 NDC 15330-100-01

bottles of 1000 NDC 15330-100-10

2 mg: (lavender, round, flat-faced, beveled-edged tablets with “WF” scoreline “2″ on one side and “G” on the other side)

bottles of 100 NDC 15330-101-01

bottles of 1000 NDC 15330-101-10

2.5 mg: (green, round, flat-faced, beveled-edged tablets with “WF” scoreline “2.5″ on one side and “G” on the other side)

bottles of 100 NDC 15330-102-01

bottles of 1000 NDC 15330-102-10

3 mg: (brown, round, flat-faced, beveled-edged tablets with “WF” scoreline “3″ on one side and “G” on the other side)

bottles of 100 NDC 15330-266-01

4 mg: (blue, round, flat-faced, beveled-edged tablets with “WF” scoreline “4″ on one side and

“G” on the other side)

bottles of 100 NDC 15330-267-01

5 mg: (peach, round, flat-faced, beveled-edged tablets with “WF” scoreline “5″ on one side and

“G” on the other side)

bottles of 100 NDC 15330-268-01

bottles of 1000 NDC 15330-268-10

6 mg: (dark green, round, flat-faced, beveled-edged tablets with “WF” scoreline “6″ on one side

and “G” on the other side)

bottles of 100 NDC 15330-106-01

7.5 mg: (yellow, round, flat-faced, beveled-edged tablets with “WF” scoreline “7.5″ on one side

and “G” on the other side)

bottles of 100 NDC 15330-107-01

10 mg: (white, round, flat-faced, beveled-edged tablets with “WF” scoreline “10″ on one side and

“G” on the other side)

bottles of 100 NDC 15330-108-01

Protect from light. Store at controlled room temperature (59°-86°F, 15°-30°C).

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

REFERENCES

1. Hurlen M, Abdelnoor M, Smith P, Erikssen J, Arnesen H. Warfarin, aspirin, or both after myocardial infarction. N Engl J Med. 2002;347:969-974.

2. Mok CK, Boey J,Wang R, et al.Warfarin versus dipyridamole-aspirin and pentoxifylline-aspirin for prevention of prosthetic valve thromboembolism: a prospective randomized clinical trial. Circ. 1985;72:1059-1063.

3. Saour JN, Sieck JO, Mamo LA, Gallus AS. Trial of different intensities of anticoagulation in patients with prosthetic heart valves. N Engl J Med. 1990;322:428-432.

4. Turpie AG, Hirsh J, Gunstensen J, Nelson H, Gent M. Randomized comparison to two intensities of oral anticoagulant therapy after tissue heart valve replacement. Lancet. 1988;331:1242-1245.

5. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126:401S-428S.

6. Warkentin TE, Elavathil LJ, Hayward CPM, Johnston MG, Russett JI, Kelton JG. The pathogenesis of venous limb gangrene associated with heparin-induced thrombocytopenia. Ann Intern Med. 1997;127:804-812.

7. COUMADIN Medication Guide. Princeton, NJ: Bristol-Myers Squibb Company; 2006.

8. Salem DN, Stein PD, Al-Ahmad A, et al. Antithrombotic therapy in valvular heart disease–native and prosthetic. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126:457S-482S.

9. American Geriatrics Society Clinical Practice Guidelines. The use of oral anticoagulants (warfarin) in older people. J Amer Geriatr Soc. 2000;48:224-227.

10. Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126:429S-456S.

11. Jaffer AK, Bragg L. Practical tips for warfarin dosing and monitoring. Cleveland Clinic J Med. 2003;70:361-371.

12. Jaffer AK, Brotman DJ, Chukwumerije N. When patients on warfarin need surgery. Cleveland Clinic J Med. 2003;70:973-984.

13. Kearon C, Ginsberg JS, Kovacs MJ, et al, for the Extended Low-Intensity Anticoagulation for Thrombo-Embolism Investigators. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med. 2003;349:631-639.

14. Schulman S, Granqvist S, Holmström M, et al, and the Duration of Anticoagulation Trial Study Group. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med.1997;336:393-398.

15. Ridker PM, Goldhaber SZ, Danielson E, et al, for the PREVENT Investigators. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med. 2003;348:1425-1434.

16. Harrington RA, Becker RC, Ezekowitz M, et al. Antithrombotic therapy for coronary artery disease. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126:513S-548S.

17. Ansell J, Hirsh J, Pollen L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest . 2004;126:204S-233S.

18. Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006;367:404-411.

Manufactured For:

Genpharm, L.P.

Napa, CA 94558

Manufactured by:

Genpharm Inc.

Mississauga, ON L5T 1T5

Canada

Printed in Canada

012-140 REV.#02 Issue date: November 2006

MEDICATION GUIDE WARFARIN

Warfarin Sodium Tablets, USP Crystalline

Read this Medication Guide before you start taking WARFARIN (Warfarin Sodium) 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 when you start taking it and at regular checkups.

What is the most important information I should know about WARFARIN?

Take your WARFARIN exactly as prescribed to lower the chance of bloodclots forming in your body. (See “What is WARFARIN?”).

WARFARIN is very important for your health, but it can cause serious and life-threatening bleeding problems. To benefit from WARFARIN and also lower your chance for bleeding problems, you must:

Get your regular blood test to check for your response to WARFARIN.

This blood test is called a PT/INR test. The PT/INR test checks to see how fast your blood clots. Your healthcare provider will decide what PT/INR numbers are best for you. Your dose of WARFARIN will be adjusted to keep your PT/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)

• nose bleeds

• 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

Many other medicines, including prescription and non-prescription

medicines, vitamins and herbal supplements can interact with WARFARIN

and:

affect the dose you need, or

increase WARFARIN side effects.

Tell your healthcare provider about all the medicines you take. Do not stop medicines or take anything new unless you have talked to your healthcare provider. Keep a list of your medicines with you at all times to show your healthcare provider and pharmacist.

• Do not take other medicines that contain warfarin. Warfarin is the activeingredient in WARFARIN.

Some foods can interact with WARFARIN and affect your treatment anddose.

Eat a normal, balanced diet. Talk to your doctor 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.

Avoid drinking cranberry juice or eating cranberry products.

Avoid drinking alcohol.

Always tell all of your healthcare providers that you take WARFARIN.

Wear or carry information that you take WARFARIN.

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