Warfarin Sodium (Tablet)
Description: Warfarin sodium (crystalline), is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-��-Acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R-and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its molecular formula is CHNaO, its molecular weight is 330.31, and its structural formula may be represented by the following: Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether. Warfarin sodium tablets, for oral administration contain either 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium. In addition they also contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, stearic acid and, 1 mg tablets: FD&C Red # 40 Aluminum Lake 2 mg tablets: FD&C Blue # 2 Aluminum Lake and FD&C Red # 40 Aluminum Lake 2.5 mg tablets: D&C Yellow # 10 Aluminum Lake and FD&C Blue # 1 Aluminum Lake 3 mg tablets: FD&C Yellow # 6 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red #40 Aluminum Lake 4 mg tablets: FD&C Blue # 1 Aluminum Lake 5 mg tablets: FD&C Yellow # 6 Aluminum Lake 6 mg tablets: FD&C Blue # 1 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake 7.5 mg tablets: D&C Yellow # 10 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake 10 mg tablets: Dye Free
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation, such as: Pregnancy:Warfarin sodium tablets are contraindicated in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus in utero. Furthermore, there have been reports of birth malformations in children born to mothers who have been treated with warfarin during pregnancy. Embryopathy characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) has been reported in pregnant women exposed to warfarin during the first trimester. Central nervous system abnormalities also have been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, Dandy-Walker malformation, and midline cerebellar atrophy. Ventral midline dysplasia, characterized by optic atrophy, and eye abnormalities have been observed. Mental retardation, blindness, and other central nervous system abnormalities have been reported in association with second and third trimester exposure. Although rare, teratogenic reports following in utero exposureto warfarin include urinary tract anomalies such as single kidney, asplenia, anencephaly, spina bifida, cranial nerve palsy, hydrocephalus, cardiac defects and congenital heart disease, polydactyly, deformities of toes, diaphragmatic hernia, corneal leukoma, cleft palate, cleft lip, schizencephaly, and microcephaly. Spontaneous abortion and still birth are known to occur and a higher risk of fetal mortality is associated with the use of warfarin. Low birth weight and growth retardation have also been reported. Women of childbearing potential who are candidates for anticoagulant therapy should be carefully evaluated and the indications critically reviewed with the patient. If the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the possibility of termination of the pregnancy should be discussed in light of those risks. Hemorrhagic tendencies or blood dyscrasias. Recent or contemplated surgery of: (1) central nervous system; (2) eye; (3) traumatic surgery resulting in large open surfaces. Bleeding tendencies associated with active ulceration or overt bleeding of: (1) gastrointestinal, genitourinary or respiratory tracts; (2) cerebrovascular hemorrhage; (3) aneurysms-cerebral, dissecting aorta; (4) pericarditis and pericardial effusions; (5) bacterial endocarditis. Threatened abortion, eclampsia and preeclampsia. Inadequate laboratory facilities. Unsupervised patients with senility, alcoholism, or psychosis or other lack of patient cooperation. Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding. Miscellaneous: major regional, lumbar block anesthesia, malignant hypertension and known hypersensitivity to warfarin or to any other components of this product.
Non-proprietary / generic name: Warfarin Sodium
Potential adverse reactions to warfarin sodium may include: Rare events of tracheal or tracheobronchial calcification have been reported in association with long-term warfarin therapy. The clinical significance of this event is unknown. Priapism has been associated with anticoagulant administration, however, a causal relationship has not been established.
See also: http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3580