COUMADIN (Page 2 of 9)

2.4 Monitoring to Achieve Optimal Anticoagulation

COUMADIN has a narrow therapeutic range (index), and its action may be affected by factors such as other drugs and dietary vitamin K. Therefore, anticoagulation must be carefully monitored during COUMADIN therapy. Determine the INR daily after the administration of the initial dose until INR results stabilize in the therapeutic range. After stabilization, maintain dosing within the therapeutic range by performing periodic INRs. The frequency of performing INR should be based on the clinical situation but generally acceptable intervals for INR determinations are 1 to 4 weeks. Perform additional INR tests when other warfarin products are interchanged with COUMADIN, as well as whenever other medications are initiated, discontinued, or taken irregularly. Heparin, a common concomitant drug, increases the INR [see Dosage and Administration (2.8) and Drug Interactions (7)].

Determinations of whole blood clotting and bleeding times are not effective measures for monitoring of COUMADIN therapy.

2.5 Renal Impairment

No dosage adjustment is necessary for patients with renal failure. Monitor INR more frequently in patients with compromised renal function to maintain INR within the therapeutic range [see Warnings and Precautions(5.4) and Use in Specific Populations(8.6)].

2.6 Missed Dose

The anticoagulant effect of COUMADIN persists beyond 24 hours. If a patient misses a dose of COUMADIN at the intended time of day, the patient should take the dose as soon as possible on the same day. The patient should not double the dose the next day to make up for a missed dose.

2.7 Treatment During Dentistry and Sugery

Some dental or surgical procedures may necessitate the interruption or change in the dose of COUMADIN therapy. Consider the benefits and risks when discontinuing COUMADIN even for a short period of time. Determine the INR immediately prior to any dental or surgical procedure. In patients undergoing minimally invasive procedures who must be anticoagulated prior to, during, or immediately following these procedures, adjusting the dosage of COUMADIN to maintain the INR at the low end of the therapeutic range may safely allow for continued anticoagulation.

2.8 Conversion From Other Anticoagulants

Heparin

Since the full anticoagulant effect of COUMADIN is not achieved for several days, heparin is preferred for initial rapid anticoagulation. During initial therapy with COUMADIN, the interference with heparin anticoagulation is of minimal clinical significance. Conversion to COUMADIN may begin concomitantly with heparin therapy or may be delayed 3 to 6 days. To ensure therapeutic anticoagulation, continue full dose heparin therapy and overlap COUMADIN therapy with heparin for 4 to 5 days and until COUMADIN has produced the desired therapeutic response as determined by INR, at which point heparin may be discontinued.

As heparin may affect the INR, patients receiving both heparin and COUMADIN should have INR monitoring at least:

• 5 hours after the last intravenous bolus dose of heparin, or
• 4 hours after cessation of a continuous intravenous infusion of heparin, or• 24 hours after the last subcutaneous heparin injection.

COUMADIN may increase the activated partial thromboplastin time (aPTT) test, even in the absence of heparin. A severe elevation (>50 seconds) in aPTT with an INR in the desired range has been identified as an indication of increased risk of postoperative hemorrhage.

Other Anticoagulants

Consult the labeling of other anticoagulants for instructions on conversion to COUMADIN.

3 DOSAGE FORMS AND STRENGTHS

Tablets

COUMADIN Single-Scored Tablets
Strength Color Superimposed Imprint

1 mg

Pink

1

2 mg

Lavender

2

2.5 mg

Green

2-1/2

3 mg

Tan

3

4 mg

Blue

4

5 mg

Peach

5

6 mg

Teal

6

7.5 mg

Yellow

7-1/2

10 mg

White (dye-free)

10

4 CONTRAINDICATIONS

COUMADIN is contraindicated in:

• Pregnancy

COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)]. COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If COUMADIN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].

COUMADIN is contraindicated in patients with:

• Hemorrhagic tendencies or blood dyscrasias

• Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see Warnings and Precautions (5.8)]

• Bleeding tendencies associated with:

— Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract

— Central nervous system hemorrhage

— Cerebral aneurysms, dissecting aorta

— Pericarditis and pericardial effusions

— Bacterial endocarditis

• Threatened abortion, eclampsia, and preeclampsia

• Unsupervised patients with conditions associated with potential high level of non-compliance

• Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding

• Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [see Adverse Reactions (6)]

• Major regional or lumbar block anesthesia

• Malignant hypertension

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