COUMADIN 5MG TAB (TABLET)

Dosage / Direction for Use: Individualized dosage & duration of treatment. Initially 2-5 mg daily. Maintenance: 2-10 mg daily. Overdosage: Symptoms: Suspected or overt abnormal bleeding (ie, appearance of blood in stools or urine, hematuria, excessive menstrual bleeding, melena, petechiae, excessive bruising or persistent oozing from superficial injuries) are early manifestations of anticoagulation beyond a safe and satisfactory level. Treatment: Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing Coumadin therapy and if necessary, by administration of oral or parenteral vitamin K1. (See recommendations accompanying vitamin K1 preparations prior to use.) Such use of vitamin K1 reduces response to subsequent Coumadin therapy. Patients may return to a pre-treatment thrombotic status following the rapid reversal of a prolonged PT. Resumption of Coumadin administration reverses the effect of vitamin K1 and a therapeutic PT can again be obtained by careful dosage adjustment. If rapid anticoagulation is indicated, heparin may be preferable for initial therapy. If minor bleeding progresses to major bleeding, give 5-25 mg (rarely up to 50 mg) parenteral vitamin K1. In emergency situations of severe hemorrhage, clotting factors can be returned to normal by administering 200-500 mL of fresh whole blood or fresh frozen plasma, or by giving commercial Factor IX complex. A risk of hepatitis and other viral diseases is associated with the use of these blood products; Factor IX complex is also associated with an increased risk of thrombosis. Therefore, these preparations should be used only in exceptional or life-threatening bleeding episodes secondary to Coumadin overdosage. Purified Factor IX preparations should not be used because they cannot increase the levels of prothrombin, Factor VII and Factor X which are also depressed along with the levels of Factor IX as a result of Coumadin treatment. Packed red blood cells may also be given if significant blood loss has occurred. Infusions of blood or plasma should be monitored carefully to avoid precipitating pulmonary edema in elderly patients or patients with heart disease. Administration: May be taken with or without food. Contraindications: Hypersensitivity. Hemorrhagic tendency or blood dyscrasias. Recent or contemplated surgery of CNS, eye or traumatic surgery resulting in large open surfaces. Bleeding tendencies associated w/ active ulceration or overt bleeding of GI, genitourinary or resp tracts; cerebrovascular hemorrhage; cerebral aneurysms, dissecting aorta; pericarditis & pericardial effusions; bacterial endocarditis. Threatened abortion, eclampsia & preeclampsia. Unsupervised patients w/ senility, alcoholism, psychosis or lack of patient cooperation. Spinal puncture. Major regional, lumbar block anesth, malignant HTN. Pregnancy. Warnings: The most serious risks associated with anticoagulant therapy with warfarin sodium are hemorrhage in any tissue or organ and, less frequently, necrosis and/or gangrene of skin and other tissues. The risk of hemorrhage is related to the level of intensity and the duration of anticoagulant therapy. Hemorrhage and necrosis have, in some cases, been reported to result in death or permanent disability. Necrosis appears to be associated with local thrombosis and usually appears within a few days of the start of anticoagulant therapy. In severe cases of necrosis, treatment through debridement or amputation of the affected tissue, limb, breast or penis has been reported. Careful diagnosis is required to determine whether necrosis is caused by an underlying disease. Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation. Although various treatments have been attempted, no treatment for necrosis has been considered uniformly effective. The following information on predisposing conditions. These and other risks associated with anticoagulant therapy must be weighed against the risk of thrombosis or embolization in untreated cases. It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. Dosage should be controlled by periodic determinations of prothrombin time (PT) or other suitable coagulation tests. Determinations of whole blood clotting and bleeding times are not effective measures for control of therapy. Heparin prolongs the 1-stage PT. When heparin and Coumadin are administered concomitantly, refer to conversion from heparin therapy for recommendations. Caution should be observed when Coumadin is administered in any situation or in the presence of any predisposing condition where added risk of hemorrhage or necrosis is present. Anticoagulation therapy with Coumadin may enhance the release of atheromatous plaque emboli, thereby increasing the risk of complications from systemic cholesterol microembolization, including the "purple toes syndrome." Discontinuation of Coumadin therapy is recommended when such phenomena are observed. Systemic atheroemboli and cholesterol microemboli can present with a variety of signs and symptoms including purple toes syndrome, livedo reticularis, rash, gangrene, abrupt and intense pain in the leg, foot or toes, foot ulcers, myalgia, penile gangrene, abdominal pain, flank or back pain, hematuria, renal insufficiency, hypertension, cerebral ischemia, spinal cord infarction, pancreatitis, symptoms stimulating polyarteritis, or any other sequelae of vascular compromise due to embolic occlusion. The most commonly involved visceral organs are the kidneys followed by the pancreas, spleen and liver. Some cases have progressed to necrosis or death. Purple toes syndrome is a complication of oral anticoagulation characterized by a dark, purplish or mottled color of the toes, usually occurring between 3-10 weeks, or later, after the initiation of therapy with warfarin or related compounds. Major features of this syndrome include purple color of plantar surfaces and sides of the toes that blanches on moderate pressure and fades with elevation of the legs; pain and tenderness of the toes; waxing and waning of the color over time. While the purple toes syndrome is reported to be reversible, some cases progress to gangrene or necrosis which may require debridement of the affected area or may lead to amputation. 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. Use in lactation: Coumadin appears in the milk of nursing mothers in an inactive form. Infants nursed by Coumadin-treated mothers had no change in prothrombin times (PTs). Effects in premature infants have not been evaluated. Severe to moderate hepatic or renal insufficiency. Infectious diseases or disturbances of gastrointestinal 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: This hereditary or acquired condition, which should be suspected if there is a history of recurrent episodes of thromboembolic disorders in the patient or in the family, has been associated with an increased risk of developing necrosis following warfarin administration. Tissue necrosis may occur in the absence of protein C deficiency. It has been reported that concurrent anticoagulation therapy with heparin for 5-7 days during initiation of therapy with Coumadin may minimize the incidence of this reaction. Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation. Miscellaneous: Polycythemia vera, vasculitis, severe diabetes, severe allergic and anaphylactic disorders. Patients with congestive heart failure may become more sensitive to Coumadin, thereby requiring more frequent laboratory monitoring and reduced doses of Coumadin. Concurrent use of anticoagulants with streptokinase or urokinase is not recommended and may be hazardous. (Please note recommendations accompanying these preparations.) Special Precautions: Any predisposing condition where added risk of hemorrhage, necrosis &/or gangrene is present. Determine prothrombin time/INR or other suitable coagulation tests periodically. Known or suspected hereditary, familial or clinical deficiency in protein has been associated w/ an increased risk of developing necrosis during warfarin administration. Discontinue use when systemic cholesterol microembolization including "purple toes syndrome" occurs. Patients w/ heparin-induced thrombocytopenia & DVT. Severe elevation in activated partial thromboplastin time (>50 sec). Severe to moderate HTN, hepatic or renal insufficiency. Infectious diseases or disturbances of intestinal flora. Surgery or trauma. Indwelling catheters. Polycythemia vera, vasculitis & severe diabetes. CHF. Concomitant use w/ streptokinase or urokinase. Women of childbearing potential. Use in children: Safety and effectiveness in children <18 years have not been established. Use in pregnancy: Pregnancy Category X: See Contraindications. Use in lactation: Coumadin appears in the milk of nursing mothers in an inactive form. Infants nursed by Coumadin-treated mothers had no change in prothrombin times (PTs). Effects in premature infants have not been evaluated. Side Effects / Adverse Reactions: Fatal or non-fatal hemorrhage, bleeding, necrosis of skin & other tissues. Interactions: Antiarrhythmics, oral aminoglycosides, parenteral cephalosporins, macrolides, high-dose IV penicillins, quinolones, long-acting sulfonamides, tetracyclines, anticonvulsants, antidepressants, antineoplastics, antithyroid drugs, diuretics, systemic fungal medications, gastric acidity & peptic ulcer agents, hypnotics, bile acid binding resins, adrenocortical steroids, TB agents, vit. Bromelains, danshen, dong quai (Angelica sinensis), garlic, Ginkgo biloba, ginseng, cranberry products; co-enzyme Q10 & St. John's wort.