Stati Uniti - Ingliż - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24), simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. ezetimibe and simvastatin tablets are contraindicated in the following conditions: ezetimibe and simvastatin tablets the safety and effectiveness of ezetimibe in combination with a statin 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 ezetimibe and simvastatin tablets for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with hefh [see clinical studies (14)]. in this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females. the safety and effectiveness of ezetimibe and simvastatin 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. in a clinical trial in which patients at high risk of cvd were treated with simvastatin 40 mg/day (median follow-up 3.9 years), the incidence of myopathy was approximately 0.05% for non-chinese patients (n=7367) compared with 0.24% for chinese patients (n=5468). in this trial the incidence of myopathy for chinese patients on simvastatin 40 mg/day or ezetimibe and simvastatin 10/40 mg/day coadministered with extended-release niacin 2 g/day was 1.24%. chinese patients may be at higher risk for myopathy, monitor these patients appropriately. coadministration of ezetimibe and simvastatin tablets with lipid-modifying doses of niacin-containing products (≥1 g/day niacin) is not recommended in chinese patients [see warnings and precautions ( 5.1) and drug interactions ( 7.1 )] .

Stati Uniti - Ingliż - NLM (National Library of Medicine)

golden state medical supply - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - therapy with lovastatin tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin tablets are indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology , clinical studies in adults .) lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-c and ldl-c to target levels. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. lovastatin tablets are indicated as an adjunct to diet for the reduction of elevated total-c and ldl-c levels in patients with primary hypercholesterolemia (types iia and iib 2 ), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. 2 classification of hyperlipoproteinemias lipid elevations type lipoproteins elevated major minor i 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 ↑→c idl = intermediate-density lipoprotein. lovastatin tablets are indicated as an adjunct to diet to reduce total-c, ldl-c and apolipoprotein b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh if after an adequate trial of diet therapy the following findings are present: - ldl-c remains > 189 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 cvd risk factors are present in the adolescent patient prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-c, hdl-c, and tg. for patients with tg less than 400 mg/dl (< 4.5 mmol/l), ldl-c can be estimated using the following equation: ldl-c = total-c - [0.2 x (tg) + hdl-c] for tg levels > 400 mg/dl (> 4.5 mmol/l), this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases, lovastatin tablets are not indicated. the national cholesterol education program (ncep) treatment guidelines are summarized below: risk category ldl goal (mg/dl) ldl level at which to initiate therapeutic lifestyle changes (mg/dl) ldl level at which to consider drug therapy (mg/dl) chd 1 or chd risk equivalents (10 year risk > 20%) < 100 ≥ 100 ≥ 130 (100 to 129: drug optional) 2 2+ risk factors (10 year risk ≤ 20%) < 130 ≥ 130 10 year risk 10 to 20%: ≥ 130 10 year risk < 10%: ≥ 160 0 to 1 risk factor 3 < 160 ≥ 160 ≥ 190 (160 to 189: ldl-lowering drug optional) - chd, coronary heart disease - some authorities recommend use of ldl-lowering drugs in this category if an ldl-c level of < 100 mg/dl cannot be achieved by therapeutic lifestyle changes. others prefer use of drugs that primarily modify triglycerides and hdl-c, e.g., nicotinic acid or fibrate. clinical judgment also may call for deferring drug therapy in this subcategory. - almost all people with 0 to 1 risk factor have a 10 year risk < 10%; thus, 10 year risk assessment in people with 0 to 1 risk factor is not necessary. after the ldl-c goal has been achieved, if the tg is still ≥ 200 mg/dl, non-hdl-c (total-c minus hdl-c) becomes a secondary target of therapy. non-hdl-c goals are set 30 mg/dl higher than ldl-c goals for each risk category. at the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the ldl-c is ≥ 130 mg/dl (see ncep treatment guidelines above). since the goal of treatment is to lower ldl-c, the ncep recommends that ldl-c levels be used to initiate and assess treatment response. only if ldl-c levels are not available, should the total-c be used to monitor therapy. although lovastatin tablets may be useful to reduce elevated ldl-c levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (type iib hyperlipoproteinemia), it has 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). 2 the ncep classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below: category total-c (mg/dl) ldl-c (mg/dl) acceptable < 170 < 110 borderline 170 to 199 110 to 129 high ≥ 200 ≥ 130 children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for ldl-c. hypersensitivity to any component of this medication. active liver disease or unexplained persistent elevations of serum transaminases (see warnings ). concomitant administration with strong cyp3a4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, hiv protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and cobicistat-containing products) (see warnings , myopathy/rhabdomyolysis ). (see precautions , pregnancy and nursing mothers .) 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. moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. because of the ability of inhibitors of hmg-coa reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. if the patient becomes pregnant while taking this drug, lovastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see precautions , pregnancy ).

Stati Uniti - Ingliż - NLM (National Library of Medicine)

eisai inc. - lemborexant (unii: 0k5743g68x) (lemborexant - unii:0k5743g68x) - dayvigo is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see clinical studies ( 14.1 )] . dayvigo is contraindicated in patients with narcolepsy. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to dayvigo during pregnancy. healthcare providers are encouraged to register patients in the dayvigo pregnancy registry, a part of the national pregnancy registry for psychiatric medications, at1-866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry. risk summary there are no available data on dayvigo use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of lemborexant to pregnant rats and rabbits during the period of organogenesis caused toxicities only at high multiples of the human exposure at the maximum recommended human dose (mrhd) based on auc. the no observed adverse effect levels (noael) are approximately >100 and 23 times the mrhd based on auc in rats and rabbits, respectively. similarly, oral administration of lemborexant to pregnant and lactating rats caused toxicities only at high multiples of the human exposure at the mrhd based on auc. the noael is 93 times the mrhd based on auc ( see data ) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data lemborexant was administered orally to pregnant rats during the period of organogenesis in 2 studies at doses of 60, 200, and 600 mg/kg/day or 20, 60, and 200 mg/kg/day, which are approximately 6 to >300 times the mrhd based on auc. lemborexant caused maternal toxicity, manifested by decreased body weight and food consumption, decreased mean fetal body weight, an increased number of dead fetuses, and skeletal, external and visceral malformations (omphalocele, cleft palate, and membranous ventricular septal defect) at >300 times the mrhd based on auc. the noael of 200 mg/kg/day is approximately 143 times the mrhd based on auc. lemborexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 10, 30, and 100 mg/kg/day, which are approximately 7 to 139 times the mrhd based on auc. lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and a higher incidence of skeletal variations (presence of cervical ribs and supernumerary lung lobes) at approximately 139 times the mrhd based on auc. the noael of 30 mg/kg/day is approximately 23 times the mrhd based on auc. lemborexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 100, and 300 mg/kg/day, which are approximately 15 to 206 times the mrhd based on auc. lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and toxicity to offspring consisting of decreased pup body weights, decreased femur length, and decreased acoustic startle responses at 206 times the mrhd based on auc. the noael of 100 mg/kg/day is approximately 93 times the mrhd based on auc. risk summary available data from a lactation study in 8 women indicates that lemborexant is transferred into the breastmilk of nursing mothers, and the results have established a mean daily infant dose of 0.0029 mg/kg/day and a relative infant dose of less than 2% of the maternal dose. these data support that transfer of lemborexant into breastmilk is low (see data). there are no data on the effects of lemborexant on the breastfed infant, or the effects on milk production. infants exposed to dayvigo through breastmilk should be monitored for excessive sedation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dayvigo and any potential adverse effects on the breastfed infant from dayvigo or from the underlying maternal condition. data a single dose milk-only lactation study was conducted in 8 healthy adult lactating women. the mean amount of lemborexant recovered in human milk was 0.0174 mg following a 10 mg maternal dose. the mean calculated daily infant oral dosage was 0.0029 mg/kg/day based on nominal infant body weight of 6 kg. approximately 70% of the total amount of lemborexant excreted in milk was excreted by 24 hours after a single maternal dose administration. there are no data on the effects of lemborexant on the breastfed infant, the effects on milk production, or infant exposure after repeated maternal dosing of lemborexant. the safety and effectiveness of dayvigo have not been established in pediatric patients. of the total number of patients treated with dayvigo (n=1418) in controlled phase 3 studies, 491 patients were 65 years and over, and 87 patients were 75 years and over. overall, efficacy results for patients <65 years of age were similar compared to patients ≥65 years. in a pooled analysis of study 1 (the first 30 days) and study 2, the incidence of somnolence in patients ≥65 years with dayvigo 10 mg was higher (9.8%) compared to 7.7% in patients <65 years. the incidence of somnolence with dayvigo 5 mg was similar in patients ≥65 years (4.9%) and <65 years (5.1%). the incidence of somnolence in patients treated with placebo was 2% or less regardless of age [see clinical studies ( 14.2 )].  because dayvigo can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see warning s and precautions ( 5.1 )] . exercise caution when using doses higher than 5 mg in patients ≥65 years old.  no dose adjustment is required in patients with mild, moderate, or severe renal impairment. dayvigo exposure (auc) was increased in patients with severe renal impairment. patients with severe renal impairment may experience an increased risk of somnolence [see clinical pharmacology ( 12.3 )]. dayvigo has not been studied in patients with severe hepatic impairment. use in this population is not recommended [see dosage and administration ( 2.3 ), clinical pharmacology ( 12.3 )].   dayvigo exposure (auc and cmax ) and terminal half-life were increased in patients with moderate hepatic impairment (child-pugh class b). dosage adjustment is recommended in patients with moderate hepatic impairment (child-pugh class b) [see dosage and administration ( 2.3 ), clinical pharmacology ( 12.3 )].   dayvigo exposure (auc) was increased in patients with mild hepatic impairment (child-pugh class a), but the terminal half-life was not changed. patients with mild hepatic impairment may experience an increased risk of somnolence [see clinical pharmacology ( 12.3 )]. obstructive sleep apnea (osa) the respiratory depressant effect of dayvigo was evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 37 patients with mild osa (apnea-hypopnea index < 15 events per hour of sleep). following once daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the apnea-hypopnea index was -0.06 (95% ci: -1.95 to 1.83). dayvigo was also evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 33 patients with moderate to severe osa (apnea-hypopnea index ≥ 15 events per hour of sleep). following once daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the apnea-hypopnea index was -0.80 (95% ci: -4.88 to 3.29). due to study limitations, including the short duration of the study, clinically meaningful respiratory effects of dayvigo in osa cannot be excluded, including for long-term treatment [see warnings and precautions ( 5.4 )] . chronic obstructive pulmonary disease (copd) the respiratory depressant effect of dayvigo was evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 30 patients with moderate to severe copd (forced expiratory volume in the first second (fev1 )/forced vital capacity (fvc) ratio ≤ 70% and 30% ≤ fev1 < 80% of predicted). following once-daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the mean peripheral capillary oxygen saturation during sleep was 0.47 (95% ci: 0.07 to 0.87). dayvigo has not been studied in copd patients with a fev1 < 30% of predicted. clinically meaningful respiratory effects of dayvigo in patients with compromised respiratory function cannot be excluded [see warnings and precautions ( 5.4 )] . dayvigo contains lemborexant, a schedule iv controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study conducted in recreational sedative abusers (n=29), lemborexant 10 mg, 20 mg (two times the maximum recommended dose), and 30 mg (three times the maximum recommended dose) produced responses on positive subjective measures such as “drug liking,” “overall drug liking,” “take drug again,” and “good drug effects” that were statistically similar to those produced by the sedatives zolpidem (30 mg) and suvorexant (40 mg), and statistically greater than the responses on these measures that were produced by placebo. because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to dayvigo, follow such patients carefully. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. in animal studies and clinical trials evaluating physical dependence, chronic administration of lemborexant did not produce withdrawal signs or symptoms upon drug discontinuation. this suggests that lemborexant does not produce physical dependence.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

quallent pharmaceuticals health llc - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsu

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

astrazeneca limited - goserelin acetate 11.34mg equivalent to 10.8 mg goserelin;   - injection (depot) - 10.8 mg - active: goserelin acetate 11.34mg equivalent to 10.8 mg goserelin   excipient: polyglactin - zoladex 10.8 mg is indicated for the management of: 1. prostate cancer suitable for hormonal manipulation.

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

les laboratoires servier - perindopril arginine, indapamide, amlodipine besilate - film coated tablet - 10/2.5/10 milligram - ace inhibitors, other combinations

Stati Uniti - Ingliż - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 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 has 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, usp 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 precautions (5.

Stati Uniti - Ingliż - 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

Stati Uniti - Ingliż - NLM (National Library of Medicine)

avkare - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 10 mg - 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 nonpharmacologic measures alone has been inadequate. in hypercholesterolemic patients without clinically evident coronary heart disease (chd), pravastatin sodium tablets are indicated to: - reduce the risk of myocardial infarction (mi). - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. in patients with clinically evident chd, pravastatin sodium tablets are indicated to: - reduce the risk of total mortality by reducing coronary death. - reduce the risk of mi. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data ]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations ]. no adverse developmental effects were observe