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

sun pharma anz pty ltd - fenofibrate, quantity: 48 mg - tablet - excipient ingredients: sucrose; pregelatinised maize starch; silicon dioxide; sodium lauryl sulfate; sodium stearylfumarate; hypromellose; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

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

sun pharma anz pty ltd - fenofibrate, quantity: 145 mg - tablet - excipient ingredients: pregelatinised maize starch; sodium stearylfumarate; crospovidone; sodium lauryl sulfate; silicon dioxide; microcrystalline cellulose; hypromellose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

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

sandoz pty ltd - fenofibrate, quantity: 145 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; hypromellose; magnesium stearate; croscarmellose sodium; sucrose; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate sandoz is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes. fenofibrate sandoz is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. fenofibrate sandoz does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

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

viatris pty ltd - fenofibrate, quantity: 48 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; lactose monohydrate; sucrose; hypromellose; docusate sodium; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; xanthan gum; polyvinyl alcohol; quinoline yellow aluminium lake; lecithin; indigo carmine aluminium lake - fenofibrate viatris is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

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

viatris pty ltd - fenofibrate, quantity: 145 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; sodium lauryl sulfate; crospovidone; hypromellose; magnesium stearate; lactose monohydrate; docusate sodium; microcrystalline cellulose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate viatris is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

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

sun pharmaceutical industries, inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 54 mg - fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 d

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

ncs healthcare of ky, inc dba vangard labs - fenofibrate (unii: u202363uos) (fenofibrate - unii:u202363uos) - fenofibrate 200 mg - fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of ldl-c, total-c, triglycerides and apo b in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of feno

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

glenmark pharmaceuticals inc., usa - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 67 mg - fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of ldl-c, total-c, triglycerides and apo b in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. drug therapy is not indicated for patients with type i hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (vldl). inspection of plasma refrigerated for 14 hours is helpful in distinguishing types i, iv and v hyperlipoproteinemia2 . the initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. physical exercise can be an important ancillary measure. diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. in such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. the use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. if the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see error! hyperlink reference not valid. and error! hyperlink reference not valid. ). fredrickson classification of hyperlipoproteinemias lipid elevation type lipoprotein elevated major minor i (rare) chylomicrons tg ↑↔c iia ldl c - iib ldl, vldl c tg iii (rare) idl c, tg - iv vldl tg ↑↔c v (rare) chylomicrons, vldl tg ↑↔ ldl-cholesterol mg/dl (mmol/l) definite atherosclerotic disease1 two or more other risk factors2 initiation level goal no no ≥ 190 (≥ 4.9) < 160 (< 4.1) no yes ≥ 160 (≥ 4.1) < 130 (< 3.4) yes yes or no ≥ 1303 (≥ 3.4) < 100 (< 2.6) 1 coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). 2 other risk factors for coronary heart disease (chd) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature chd; current cigarette smoking; hypertension; confirmed hdl-c < 35 mg/dl (< 0.91 mmol/l); and diabetes mellitus. subtract 1 risk factor if hdl-c is ≥ 60 mg/dl (≥ 1.6 mmol/l). 3 in chd patients with ldl-c levels 100 to 129 mg/dl, the physician should exercise clinical judgment in deciding whether to initiate drug treatment. fenofibrate capsules are contraindicated in patients who exhibit hypersensitivity to fenofibrate. fenofibrate capsules are contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality. fenofibrate capsules are contraindicated in patients with preexisting gallbladder disease (see warnings ).

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

avpak - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 134 mg - fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of ldl-c, total-c, triglycerides and apo b in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of feno

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

lupin pharmaceuticals, inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 54 mg - fenofibrate tablet usp is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate tablet usp is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet usp was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see warnings and precautions (5.1)] . fenofibrate is contraindicated in: - patients with severe renal impairment, including those receiving dialysis [see clinical pharmacology (12.3)] . - patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see warnings and precautions (5.2)] . - patients with preexisting gallbladder disease [see warnings and precautions (5.5)] . - nursing mothers [see use in specific populations (8.2)] - patients with known hypersensitivity to fenofibrate or fenofibric acid [see warnings and precautions (5.9)]. risk summary limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 160 mg daily, based on body surface area (mg/m2 ). adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see data). fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 animal data in pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [mrhd] of 300 mg fenofibrate daily, equivalent to 160 mg fenofibrate tablets daily, based on body surface area comparisons). increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the mrhd) that significantly suppressed maternal body weight gain. in pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the mrhd, based on body surface area comparisons). aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the mrhd) that suppressed maternal body weight gain. in pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the mrhd, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the mrhd) in the presence of maternal toxicity (decreased weight gain). decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the mrhd), which was associated with decreased maternal body weight gain/maternal neglect. risk summary there is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk. because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibrate and for 5 days after the final dose [see  contraindications (4)] . safety and effectiveness have not been established in pediatric patients. fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. fenofibric acid exposure is not influenced by age. since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see dosage and administration (2.5) and clinical pharmacology (12.3)] . elderly patients with normal renal function should require no dose modifications. consider monitoring renal function in elderly patients taking fenofibrate. the use of fenofibrate should be avoided in patients who have severe renal impairment [see contraindications (4)] . dose reduction is required in patients with mild to moderate renal impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. monitoring renal function in patients with renal impairment is recommended. the use of fenofibrate has not been evaluated in subjects with hepatic impairment [see contraindications (4) and clinical pharmacology (12.3)].