United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - fluvastatin sodium - oral capsule - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - fluvastatin sodium - oral capsule - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - fluvastatin sodium - oral capsule - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - fluvastatin sodium - oral capsule - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

torrent pharma (uk) ltd - fluvastatin sodium - oral capsule - 40mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - fluvastatin sodium 84,48 mg - eq. fluvastatin 80 mg - prolonged-release tablet - 80 mg - fluvastatin sodium 84.48 mg - fluvastatin

Canada - English - Health Canada

teva canada limited - fluvastatin (fluvastatin sodium) - capsule - 20mg - fluvastatin (fluvastatin sodium) 20mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

teva canada limited - fluvastatin (fluvastatin sodium) - capsule - 40mg - fluvastatin (fluvastatin sodium) 40mg - hmg-coa reductase inhibitors

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

lannett company, inc. - 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 sodium extended-release tablets 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, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: ldl-c remains ≥ 190 mg/dl or ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - ldl-c remains ≥ 190 mg/dl or - ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - there is a positive family history of premature cardiovascular disease or - two or more other cardiovascular disease risk factors are present the ncep classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cvd is summarized below. children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. in patients with clinically evident chd, fluvastatin sodium extended-release tablets are indicated to: - reduce the risk of undergoing coronary revascularization procedures - slow the progression of coronary atherosclerosis fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, vldl, or idl (i.e., hyperlipoproteinemia types i, iii, iv, or v). fluvastatin sodium extended-release tablets are contraindicated in patients with hypersensitivity to any component of this medication. fluvastatin sodium extended-release tablets are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see warnings and precautions (5.2)] . fluvastatin sodium extended-release tablets are contraindicated in women who are pregnant or may become pregnant. serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. fluvastatin may cause fetal harm when administered to pregnant women. 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 hypercholesterolemia. fluvastatin sodium extended-release tablets should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards . if the patient becomes pregnant while taking this drug, fluvastatin sodium extended-release tablets should be discontinued and the patient should be apprised of the potential hazard to the fetus [see use in specific populations (8.1)] . fluvastatin is secreted into the breast milk of animals and because hmg-coa reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with fluvastatin sodium extended-release tablets should be advised not to breastfeed their infants [see use in specific populations (8.3)] . pregnancy category x fluvastatin is contraindicated in women who are or may become pregnant [see contraindications (4)] . lipid lowering drugs are contraindicated during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. serum cholesterol and triglycerides increase during normal pregnancy. atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. there are no adequate and well-controlled studies of use with fluvastatin during pregnancy. rare reports of congenital anomalies have been received following intrauterine exposure to other statins. in a review 2 of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. the number of cases is adequate only to exclude a 3- to 4-fold increase in congenital anomalies over background incidence. in 89% of prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.   teratology studies with fluvastatin in rats and rabbits showed maternal toxicity at high dose levels, but there was no evidence of embryotoxic or teratogenic potential [see non-clinical toxicology (13)] .  fluvastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. if a woman becomes pregnant while taking fluvastatin sodium extended-release tablets, the drug should be discontinued and the patient advised again as to the potential hazards to the fetus. based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin [see contraindications (4)] . the safety and efficacy of fluvastatin in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials for a duration of two years. the most common adverse events observed were influenza and infections. in these limited uncontrolled studies, there was no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls [see clinical studies (14.2), adverse reactions (6.3) and dosage and administration (2.2)] . adolescent females should be counseled on appropriate contraceptive methods while on fluvastatin therapy [see contraindications (4)] . fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥ 65 years) [see clinical pharmacology (12.3)] . since advanced age ( > 65 years) is a predisposing factor for myopathy, fluvastatin should be prescribed with caution in the elderly. fluvastatin is contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see clinical pharmacology (12.3)] . 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 caution should be exercised when treating such patients at higher doses [see clinical pharmacology (12.3)] .

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)] .