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

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

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 - 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

Canada - English - Health Canada

sandoz canada incorporated - fluvastatin (fluvastatin sodium) - capsule - 20mg - fluvastatin (fluvastatin sodium) 20mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

sandoz canada incorporated - fluvastatin (fluvastatin sodium) - capsule - 40mg - fluvastatin (fluvastatin sodium) 40mg - hmg-coa reductase inhibitors

Canada - English - Health Canada

sandoz canada incorporated - fluvastatin (fluvastatin sodium) - tablet (extended-release) - 80mg - fluvastatin (fluvastatin sodium) 80mg - hmg-coa reductase inhibitors

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

physicians total care, inc. - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - fluvastatin sodium 80 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)

novartis pharmaceuticals corporation - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - fluvastatin 80 mg - lescol xl is indicated: lescol xl is contraindicated in patients with: risk summary discontinue lescol xl when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. lescol xl decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, lescol xl 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 lescol xl 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 lescol xl, 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 lescol xl [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 lescol xl 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 lescol xl 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 lescol xl 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 lescol xl-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 lescol xl 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 lescol xl 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)] . lescol xl is contraindicated in patients with acute liver failure or decompensated cirrhosis [see contraindications (4), warnings and precautions (5.3)] .

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

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - fluvastatin sodium, quantity: 84.24 mg (equivalent: fluvastatin, qty 80 mg) - tablet, modified release - excipient ingredients: hypromellose; hyprolose; potassium bicarbonate; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; macrogol 8000; iron oxide yellow - hypercholesterolaemia: prior to initiating therapy with fluvastatin for treating hypercholesterolaemia, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. adults: as an adjunct to diet in the treatment of hypercholesterolaemia. heterozygous familial hypercholesterolaemia in paediatric patients: as an adjunct to diet in adolescent boys and in adolescent girls who are at least one year post-menstruation, 10-16 years of age, with heterozygous familial hypercholesterolaemia whose response to dietary restriction has not been adequate and in whom the following findings are present: 1. ldl-c remains greater than or equal to 4.9 mmol/l (190 mg/dl) or 2. ldl-c remains greater than or equal to 4.1 mmol/l (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. secondary prevention of cardiac events: for the prevention of major adverse cardiac events in adult patients with coronary heart disease who have undergone successful coronary transcatheter therapy.