Warfarin Sodium (Page 2 of 10)

2.4 Monitoring to Achieve Optimal Anticoagulation

Warfarin sodium tablets have 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 warfarin sodium tablets 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 warfarin sodium tablets 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 warfarin sodium tablets 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 warfarin sodium tablets persists beyond 24 hours. If a patient misses a dose of warfarin sodium tablets 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 Surgery

Some dental or surgical procedures may necessitate the interruption or change in the dose of warfarin sodium tablets therapy. Consider the benefits and risks when discontinuing warfarin sodium tablets 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 warfarin sodium tablets 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 warfarin sodium tablets is not achieved for several days, heparin is preferred for initial rapid anticoagulation. During initial therapy with warfarin sodium tablets, the interference with heparin anticoagulation is of minimal clinical significance. Conversion to warfarin sodium tablets 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 warfarin sodium tablets therapy with heparin for 4 to 5 days and until warfarin sodium tablets 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 warfarin sodium tablets 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.

Warfarin sodium tablets 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 warfarin sodium tablets.

3 DOSAGE FORMS AND STRENGTHS

Warfarin Sodium Tablets USP, 1 mg are supplied as pink to light pink, oval shaped uncoated scored tablets with debossing ‘761’ and ‘1’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 2 mg are supplied as lavender to light lavender, oval shaped uncoated scored tablets with debossing ‘762’ and ‘2’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 2½ mg are supplied as green to light green, oval shaped uncoated scored tablets with debossing ‘763’ and ‘2½’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 3 mg are supplied as tan to light tan, oval shaped uncoated scored tablets with debossing ‘764’ and ‘3’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 4 mg are supplied as blue to light blue, oval shaped uncoated scored tablets with debossing ‘765’ and ‘4’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 5 mg are supplied as peach to light peach, oval shaped uncoated scored tablets with debossing ‘766’ and ‘5’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 6 mg are supplied as teal to light teal, oval shaped uncoated scored tablets with debossing ‘767’ and ‘6’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 7½ mg are supplied as yellow to light yellow, oval shaped uncoated scored tablets with debossing ‘768’ and ‘7½’ on either side of the breakline on one side and ‘AN’ on the other side.

Warfarin Sodium Tablets USP, 10 mg are supplied as white to off white, oval shaped uncoated scored tablets with debossing ‘769’ and ‘10’ on either side of the breakline on one side and ‘AN’ on the other side.

4 CONTRAINDICATIONS

Warfarin sodium is contraindicated in:

  • Pregnancy

Warfarin sodium 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)]. Warfarin sodium can cause fetal harm when administered to a pregnant woman. Warfarin sodium 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 warfarin sodium 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) ].

Warfarin sodium 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

5 WARNINGS AND PRECAUTIONS

5.1 Hemorrhage

Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors [see Clinical Pharmacology (12.5)], certain concomitant drugs [see Drug Interactions (7)], and long duration of warfarin therapy.

Perform regular monitoring of INR in all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shortest duration of therapy appropriate for the clinical condition. However, maintenance of INR in the therapeutic range does not eliminate the risk of bleeding.

Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. Perform more frequent INR monitoring when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs [see Drug Interactions (7)].

Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17)].

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