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Coumadin

[Warfarin Sodium Tablets, USP]

Heparin-induced thrombocytopenia:

COUMADIN should be used with caution in patients with heparin-induced thrombocytopenia and deep venous thrombosis. Cases of venous limb ischemia, necrosis, and gangrene have occurred in patients with heparin-induced thrombocytopenia and deep venous thrombosis when heparin treatment was discontinued and warfarin therapy was started or continued. In some patients sequelae have included ampu-tation of the involved area and/ or death (Warkentin et al, 1997).

A severe elevation (> 50 seconds) in activated partial thromboplastin time (aPTT) with a PT/ INR in the desired range has been identified as an indication of increased risk of postoperative hemorrhage.

Text Continues Below



The decision to administer anticoagulants in the following conditions must be based upon clinical judgment in which the risks of anticoagulant therapy are weighed against the benefits:

Lactation:

Based on very limited published data, warfarin has not been detected in the breast milk of mothers treated with warfarin. The same limited published data reports that some breastfed infants, whose mothers were treated with warfarin, had prolonged prothrombin times, although not as prolonged as those of the mothers. The decision to breastfeed should be undertaken only after careful consideration of the available alternatives. Women who are breastfeeding and anticoagulated with warfarin should be very carefully monitored so that recommended PT/ INR values are not exceeded. It is prudent to perform coagulation tests and to evaluate vitamin K status in infants at risk for bleeding tendencies before advising women taking warfarin to breast-feed. Effects in premature infants have not been evaluated.

Severe to moderate hepatic or renal insufficiency.
Infectious diseases or disturbances of intestinal flora: sprue, antibiotic therapy.
Trauma which may result in internal bleeding.
Surgery or trauma resulting in large exposed raw surfaces.
Indwelling catheters.
Severe to moderate hypertension.
Known or suspected deficiency in protein C mediated anticoagulant response:

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