États-Unis - anglais - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets increase myocardial contractility in pediatric patients with heart failure. digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin tablets are contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually

États-Unis - anglais - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 250 ug - digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets increase myocardial contractility in pediatric patients with heart failure. digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin tablets are contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin. risk summary experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. untreated underlying maternal conditions, such as heart failure and atrial fibrillation, during pregnancy pose a risk to the mother and fetus (see clinical consideration) . animal reproduction studies have not been conducted with digoxin. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 disease-associated maternal and/or embryo/fetal risk pregnant women with heart failure are at increased risk for preterm birth. clinical classification of heart disease may worsen with pregnancy and lead to maternal or fetal death. pregnant women with atrial fibrillation are at an increased risk of delivering a low birth weight infant. atrial fibrillation may worsen with pregnancy and can lead to maternal or fetal death. fetal/neonatal adverse reactions digoxin has been shown to cross the placenta and is found in amniotic fluid. monitor neonates for signs and symptoms of digoxin toxicity, including vomiting, and cardiac arrhythmias [see warnings and precautions (5.3)]. dose adjustments during pregnancy and the postpartum period digoxin requirements may increase during pregnancy and decrease in the postpartum period. monitor serum digoxin levels during pregnancy and the postpartum period [see dosage and administration (2.5)]. labor or delivery risk of arrhythmias may increase during the labor and delivery. monitor patients continuously during labor and delivery [see warnings and precautions (5.1 and 5.2)]. risk summary the digoxin dose received through breastfeeding is up to 4% of the neonatal maintenance dosage, which is unlikely to be clinically relevant. there are no data on the effects of digoxin on the breastfed infant or the effects on milk production. data based on data from two lactation studies in a total of 13 breastfed infants, the digoxin concentrations in breast milk were between 0.4 ng/ml to 1.0 ng/ml following 0.25 mg once daily dose of digoxin in the lactating mother. thus, the amount of digoxin ingested daily by the infants is estimated to be between 0.03 to 0.16 mcg/kg/day. this translates to a relative infant dose of digoxin between 1% to 7% of the maternal weight-adjusted dose and about 0.2% to 4% of the neonatal maintenance dose. the safety and effectiveness of digoxin tablets in the control of ventricular rate in children with atrial fibrillation have not been established. the safety and effectiveness of digoxin tablets in the treatment of heart failure in children have not been established in adequate and well-controlled studies. however, in published literature of children with heart failure of various etiologies (e.g., ventricular septal defects, anthracycline toxicity, patent ductus arteriosus), treatment with digoxin has been associated with improvements in hemodynamic parameters and in clinical signs and symptoms. newborn infants display considerable variability in their tolerance to digoxin. premature and immature infants are particularly sensitive to the effects of digoxin, and the dosage of the drug must not only be reduced but must be individualized according to their degree of maturity. the majority of clinical experience gained with digoxin has been in the elderly population. this experience has not identified differences in response or adverse effects between the elderly and younger patients. however, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, which should be based on renal function, and it may be useful to monitor renal function [see dosage and administration (2.1)] . the clearance of digoxin can be primarily correlated with the renal function as indicated by creatinine clearance. tables 3 and 5 provide the usual daily maintenance dose requirements for digoxin based on creatinine clearance [see dosage and administration (2.3)] . digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin [see dosage and administration (2.3)] . because of the prolonged elimination half-life, a longer period of time is required to achieve an initial or new steady-state serum concentration in patients with renal impairment than in patients with normal renal function. if appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function. plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects. the absorption of digoxin is reduced in some malabsorption conditions such as chronic diarrhea.

États-Unis - anglais - NLM (National Library of Medicine)

major pharmaceuticals - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets increase myocardial contractility in pediatric patients with heart failure. digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin tablets are contraindicated in patients with: pregnancy risk summary experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fet

États-Unis - anglais - NLM (National Library of Medicine)

northstar rx llc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin is indicated for the treatment of mild to moderate heart failure in adults. digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin increases myocardial contractility in pediatric patients with heart failure. digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is contraindicated in patients with: risk summary experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. untreated underlying maternal conditions, suc

États-Unis - anglais - NLM (National Library of Medicine)

cardinal health 107, llc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets increase myocardial contractility in pediatric patients with heart failure. digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin tablets are contraindicated in patients with: pregnancy risk summary experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. untreated underlying maternal conditions, such as heart failure and atrial fibrillation, during pregnancy pose a risk to the mother and fetus (see clinical consideration) . animal reproduction studies have not been conducted with digoxin. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with heart failure are at increased risk for preterm birth. clinical classification of heart disease may worsen with pregnancy and lead to maternal or fetal death. pregnant women with atrial fibrillation are at an increased risk of delivering a low birth weight infant. atrial fibrillation may worsen with pregnancy and can lead to maternal or fetal death. fetal/neonatal adverse reactions digoxin has been shown to cross the placenta and is found in amniotic fluid. monitor neonates for signs and symptoms of digoxin toxicity, including vomiting, and cardiac arrhythmias [see warnings and precautions (5.3)]. dose adjustments during pregnancy and the postpartum period digoxin requirements may increase during pregnancy and decrease in the postpartum period. monitor serum digoxin levels during pregnancy and the postpartum period [see dosage and administration (2.5)]. labor or delivery risk of arrhythmias may increase during the labor and delivery. monitor patients continuously during labor and delivery [see warnings and precautions (5.1 and 5.2)]. risk summary the digoxin dose received through breastfeeding is up to 4% of the neonatal maintenance dosage, which is unlikely to be clinically relevant. there are no data on the effects of digoxin on the breastfed infant or the effects on milk production. data based on data from two lactation studies in a total of 13 breastfed infants, the digoxin concentrations in breast milk were between 0.4 – 1.0 ng/ml following 0.25 mg once daily dose of digoxin in the lactating mother. thus, the amount of digoxin ingested daily by the infants is estimated to be between 0.03 to 0.16 μg/kg/day. this translates to a relative infant dose of digoxin between 1 to 7% of the maternal weight-adjusted dose and about 0.2 to 4% of the neonatal maintenance dose. the safety and effectiveness of digoxin tablets in the control of ventricular rate in children with atrial fibrillation have not been established. the safety and effectiveness of digoxin tablets in the treatment of heart failure in children have not been established in adequate and well-controlled studies. however, in published literature of children with heart failure of various etiologies (e.g., ventricular septal defects, anthracycline toxicity, patent ductus arteriosus), treatment with digoxin has been associated with improvements in hemodynamic parameters and in clinical signs and symptoms. newborn infants display considerable variability in their tolerance to digoxin. premature and immature infants are particularly sensitive to the effects of digoxin, and the dosage of the drug must not only be reduced but must be individualized according to their degree of maturity. the majority of clinical experience gained with digoxin has been in the elderly population. this experience has not identified differences in response or adverse effects between the elderly and younger patients. however, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, which should be based on renal function, and it may be useful to monitor renal function [see dosage and administration (2.1) ]. the clearance of digoxin can be primarily correlated with the renal function as indicated by creatinine clearance. tables 3 and 5 provide the usual daily maintenance dose requirements for digoxin based on creatinine clearance [see dosage and administration (2.3) ]. digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin [see dosage and administration (2.3) ]. because of the prolonged elimination half-life, a longer period of time is required to achieve an initial or new steady-state serum concentration in patients with renal impairment than in patients with normal renal function. if appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function. plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects. the absorption of digoxin is reduced in some malabsorption conditions such as chronic diarrhea.

États-Unis - anglais - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets increase myocardial contractility in pediatric patients with heart failure. digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin tablets are contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually

Irlande - anglais - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - digoxin - solution for injection - 0.25 percent volume/volume - digitalis glycosides; digoxin

Canada - anglais - Health Canada

sandoz canada incorporated - digoxin - liquid - 0.5mg - digoxin 0.5mg - cardiotonic agents

États-Unis - anglais - NLM (National Library of Medicine)

state of florida doh central pharmacy - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - heart failure: digoxin is indicated for the treatment of mild to moderate heart failure. digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. atrial fibrillation: digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation. digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. a hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

aspen pharma pty ltd - digoxin, quantity: 0.25 mg/ml - injection, solution - excipient ingredients: citric acid monohydrate; dibasic sodium phosphate; propylene glycol; water for injections; ethanol - indications as at 26 july 2000 : congestive heart failure - lanoxin is useful regardless of whether the failure is predominantly of the left or right ventricle, or involves both sides of the heart. it is particularly useful in heart failure resulting from chronic overload (hypertension, valvular lesions, atherosclerotic heart disease) in which the supply of energy is not impaired. lanoxin does not cause major benefit in situations in which the metabolic energy supply is compromised as in thyrotoxicosis, hypoxia, and severe thiamine deficiency. atrial fibrillation - because lanoxin depresses conduction in the atrioventricular bundle, producing a slower ventricular beat, it is valuable in atrial fibrillation. it will frequently convert atrial flutter into fibrillation and, upon withdrawal of the drug, normal sinus rhythm may be restored. paroxysmal atrial tachycardia - lanoxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous.