United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. 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

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 3 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. 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

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. 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 risk summary warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see warnings and precautions ( 5.7)] . warfarin sodium can cause fetal harm. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. because these data were not collected in adequate and well-controlled studies, this incidence of major birth defects is not an adequate basis for comparison to the estimated incidences in the control group or the u.s. general population and may not reflect the incidences observed in practice. consider the benefits and risks of warfarin sodium and possible risks to the fetus when prescribing warfarin sodium to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions in humans, warfarin crosses the placenta, and concentrations in fetal plasma approach the maternal values. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. warfarin embryopathy is characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) and growth retardation (including low birth weight). central nervous system and eye abnormalities have also been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, dandy-walker malformation, midline cerebellar atrophy, and ventral midline dysplasia characterized by optic atrophy. mental retardation, blindness, schizencephaly, microcephaly, hydrocephalus, and other adverse pregnancy outcomes have been reported following warfarin exposure during the second and third trimesters of pregnancy [see contraindications ( 4)] . risk summary warfarin was not present in human milk from mothers treated with warfarin from a limited published study. because of the potential for serious adverse reactions, including bleeding in a breastfed infant, consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for warfarin sodium and any potential adverse effects on the breastfed infant from warfarin sodium or from the underlying maternal condition before prescribing warfarin sodium to a lactating woman. clinical considerations monitor breastfeeding infants for bruising or bleeding. data human data based on published data in 15 nursing mothers, warfarin was not detected in human milk. among the 15 full-term newborns, 6 nursing infants had documented prothrombin times within the expected range. prothrombin times were not obtained for the other 9 nursing infants. effects in premature infants have not been evaluated. pregnancy testing warfarin sodium can cause fetal harm [see use in specific populations ( 8.1)] . verify the pregnancy status of females of reproductive potential prior to initiating warfarin sodium therapy. contraception females advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the final dose of warfarin sodium. adequate and well-controlled studies with warfarin sodium have not been conducted in any pediatric population, and the optimum dosing, safety, and efficacy in pediatric patients is unknown. pediatric use of warfarin sodium is based on adult data and recommendations, and available limited pediatric data from observational studies and patient registries. pediatric patients administered warfarin sodium should avoid any activity or sport that may result in traumatic injury. the developing hemostatic system in infants and children results in a changing physiology of thrombosis and response to anticoagulants. dosing of warfarin in the pediatric population varies by patient age, with infants generally having the highest, and adolescents having the lowest milligram per kilogram dose requirements to maintain target inrs. because of changing warfarin requirements due to age, concomitant medications, diet, and existing medical condition, target inr ranges may be difficult to achieve and maintain in pediatric patients, and more frequent inr determinations are recommended. bleeding rates varied by patient population and clinical care center in pediatric observational studies and patient registries. infants and children receiving vitamin k-supplemented nutrition, including infant formulas, may be resistant to warfarin therapy, while human milk-fed infants may be sensitive to warfarin therapy. of the total number of patients receiving warfarin sodium in controlled clinical trials for which data were available for analysis, 1885 patients (24.4%) were 65 years and older, while 185 patients (2.4%) were 75 years and older. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients 60 years or older appear to exhibit greater than expected inr response to the anticoagulant effects of warfarin [see clinical pharmacology ( 12.3)] . warfarin sodium is contraindicated in any unsupervised patient with senility. conduct more frequent monitoring for bleeding with administration of warfarin sodium to elderly patients in any situation or with any physical condition where added risk of hemorrhage is present. consider lower initiation and maintenance doses of warfarin sodium in elderly patients [see dosage and administration ( 2.2, 2.3)] . renal clearance is considered to be a minor determinant of anticoagulant response to warfarin. no dosage adjustment is necessary for patients with renal impairment. instruct patients with renal impairment taking warfarin to monitor their inr more frequently [see warnings and precautions ( 5.4)] . hepatic impairment can potentiate the response to warfarin through impaired synthesis of clotting factors and decreased metabolism of warfarin. conduct more frequent monitoring for bleeding when using warfarin sodium in these patients.

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - pregnancy warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromb

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 5 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. 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

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 10 mg - warfarin sodium tablets,usp are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets, usp have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. - pregnancy warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precau

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - fluvastatin sodium 20 mg - therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see national cholesterol education program [ncep] treatment guidelines, below). lescol® (fluvastatin sodium) and lescol® xl (fluvastatin sodium) are indicated to reduce elevated total cholesterol (total-c), ldl-c, tg and apo b levels, and to increase hdl-c in patients with primary hypercholesterolemia and mixed dyslipidemia (fredrickson type iia and iib) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate. lescol and lescol xl are indicated as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia whose response to dietary restriction has not been adequate and the following findings are present: - ldl-c remains > 190 mg/dl or - ldl-c remains > 160 mg/dl and:

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 5 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. 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 risk summary warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see warnings and precautions (5.7)] . warfarin sodium can cause fetal harm. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. because these data were not collected in adequate and well-controlled studies, this incidence of major birth defects is not an adequate basis for comparison to the estimated incidences in the control group or the u.s. general population and may not reflect the incidences observed in practice. consider the benefits and risks of warfarin sodium and possible risks to the fetus when prescribing warfarin sodium to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions in humans, warfarin crosses the placenta, and concentrations in fetal plasma approach the maternal values. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. warfarin embryopathy is characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) and growth retardation (including low birth weight). central nervous system and eye abnormalities have also been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, dandy-walker malformation, midline cerebellar atrophy, and ventral midline dysplasia characterized by optic atrophy. mental retardation, blindness, schizencephaly, microcephaly, hydrocephalus, and other adverse pregnancy outcomes have been reported following warfarin exposure during the second and third trimesters of pregnancy [see contraindications (4)] . risk summary warfarin was not present in human milk from mothers treated with warfarin from a limited published study. because of the potential for serious adverse reactions, including bleeding in a breastfed infant, consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for warfarin sodium and any potential adverse effects on the breastfed infant from warfarin sodium or from the underlying maternal condition before prescribing warfarin sodium to a lactating woman. clinical considerations monitor breastfeeding infants for bruising or bleeding. data human data based on published data in 15 nursing mothers, warfarin was not detected in human milk. among the 15 full-term newborns, 6 nursing infants had documented prothrombin times within the expected range. prothrombin times were not obtained for the other 9 nursing infants. effects in premature infants have not been evaluated. pregnancy testing warfarin sodium can cause fetal harm [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to initiating warfarin sodium therapy. contraception females advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the final dose of warfarin sodium. adequate and well-controlled studies with warfarin sodium have not been conducted in any pediatric population, and the optimum dosing, safety, and efficacy in pediatric patients is unknown. pediatric use of warfarin sodium is based on adult data and recommendations, and available limited pediatric data from observational studies and patient registries. pediatric patients administered warfarin sodium should avoid any activity or sport that may result in traumatic injury. the developing hemostatic system in infants and children results in a changing physiology of thrombosis and response to anticoagulants. dosing of warfarin in the pediatric population varies by patient age, with infants generally having the highest, and adolescents having the lowest milligram per kilogram dose requirements to maintain target inrs. because of changing warfarin requirements due to age, concomitant medications, diet, and existing medical condition, target inr ranges may be difficult to achieve and maintain in pediatric patients, and more frequent inr determinations are recommended. bleeding rates varied by patient population and clinical care center in pediatric observational studies and patient registries. infants and children receiving vitamin k-supplemented nutrition, including infant formulas, may be resistant to warfarin therapy, while human milk-fed infants may be sensitive to warfarin therapy. of the total number of patients receiving warfarin sodium in controlled clinical trials for which data were available for analysis, 1885 patients (24.4%) were 65 years and older, while 185 patients (2.4%) were 75 years and older. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients 60 years or older appear to exhibit greater than expected inr response to the anticoagulant effects of warfarin [see clinical pharmacology (12.3)] . warfarin sodium is contraindicated in any unsupervised patient with senility. conduct more frequent monitoring for bleeding with administration of warfarin sodium to elderly patients in any situation or with any physical condition where added risk of hemorrhage is present. consider lower initiation and maintenance doses of warfarin sodium in elderly patients [see dosage and administration (2.2, 2.3)] . renal clearance is considered to be a minor determinant of anticoagulant response to warfarin. no dosage adjustment is necessary for patients with renal impairment. instruct patients with renal impairment taking warfarin to monitor their inr more frequently [see warnings and precautions (5.4)] . hepatic impairment can potentiate the response to warfarin through impaired synthesis of clotting factors and decreased metabolism of warfarin. conduct more frequent monitoring for bleeding when using warfarin sodium in these patients.

United States - English - NLM (National Library of Medicine)

sandoz inc - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - fluvastatin sodium extended-release tablets are indicated: fluvastatin sodium extended-release tablets are contraindicated in patients with: risk summary discontinue fluvastatin sodium extended-release tablets when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. fluvastatin sodium extended-release tablets decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, fluvastatin sodium extended-release tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with fluvastatin sodium extended-release tablets’ use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data) . in animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered fluvastatin during the period of organogenesis at doses that resulted in 2 and 5 times, respectively, the human exposure at the maximum recommended human dosage of 40 mg/day, based on body surface area (mg/m2 ) (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders, including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% ci: 0.85 to 1.37) after controlling for confounders, particularly preexisting diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data fluvastatin sodium given to rats during organogenesis at doses of 12 mg/kg/day and in rabbits at doses of 10 mg/kg/day produced delays in skeletal development. these doses resulted in 2 times (rat at 12 mg/kg) or 5 times (rabbit at 10 mg/kg) the 40 mg human exposure based on mg/m2 surface area. malaligned thoracic vertebrae were seen in rats at 36 mg/kg, a dose that produced significant maternal toxicity. a study in which female rats were given fluvastatin during the third trimester at 12 and 24 mg/kg/day resulted in maternal mortality at or near term and postpartum. in addition, fetal and neonatal lethality were apparent. no effects on the dam or fetus occurred at 2 mg/kg/day. a second study at levels of 2, 6, 12 and 24 mg/kg/day confirmed the findings in the first study with neonatal mortality beginning at 6 mg/kg. rats were given fluvastatin from gestation day 15 to lactation day 21 at doses of 12 or 24 mg/kg/day with or without the presence of concurrent supplementation with mevalonic acid, a product of hmg-coa reductase which is essential for cholesterol biosynthesis. the concurrent administration of mevalonic acid completely prevented the maternal and neonatal mortality but did not prevent low body weights in pups at 24 mg/kg on days 0 and 7 postpartum. risk summary there is no information about the presence of fluvastatin in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. studies in rats have shown that fluvastatin and/or its metabolites are present in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data) . statins, including fluvastatin sodium extended-release tablets, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with fluvastatin sodium extended-release tablets [see use in specific populations (8.1), clinical pharmacology (12.1)] . data following a single oral administration of 1 mg/kg of radioactive fluvastatin to lactating rats, the concentration of total radioactivity was determined. fluvastatin and/or its metabolites were measured in the breast milk at a 2:1 ratio (milk:plasma). the safety and effectiveness of fluvastatin sodium extended-release tablets as an adjunct to diet to reduce ldl-c have been established in pediatric patients 10 years of age and older with hefh. use of fluvastatin sodium extended-release tablets for this indication is based on open-label, uncontrolled clinical trials in 114 pediatric patients 9 years of age and older with hefh. in these limited uncontrolled studies, there was no significant effect on growth or sexual maturation in the males or females, or on menstrual cycle length in females. the safety and effectiveness of fluvastatin sodium extended-release tablets have not been established in pediatric patients younger than 10 years of age with hefh or in pediatric patients with other types of hyperlipidemia (other than hefh). fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥ 65 years) [see clinical pharmacology (12.3)] . advanced age (≥ 65 years) is a risk factor for fluvastatin sodium extended-release tablets -associated myopathy and rhabdomyolysis. dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving fluvastatin sodium extended-release tablets for the increased risk of myopathy [see warnings and precautions (5.1)] . renal impairment is a risk factor for myopathy and rhabdomyolysis. dose adjustments for mild to moderate renal impairment are not necessary. fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore, use fluvastatin sodium extended-release tablets with caution in patients with severe renal impairment. monitor all patients with renal impairment for development of myopathy [see warnings and precautions (5.1), clinical pharmacology (12.3)] . fluvastatin sodium extended-release tablets are contraindicated in patients with acute liver failure or decompensated cirrhosis [see contraindications (4), warnings and precautions (5.3)] .

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. fluvastatin capsules are indicated - as an adjunct to diet to reduce elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), triglyceride (tg) and apolipoprotein b (apo b) levels, and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia and mixed dyslipidemia (fredrickson type iia and iib). - as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present