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

sandoz inc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 250 ug in 1 ml - digoxin injection is indicated for the treatment of mild to moderate heart failure in adults. digoxin injection 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 injection should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin injection increases myocardial contractility in pediatric patients with heart failure. digoxin injection is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin injection 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

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

hikma pharmaceuticals usa inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.25 mg in 1 ml - 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 is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is 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. digoxin should be given to a pregnant woman only if clearly needed.  it is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. animal reproduction studies have not been conducted with digoxin. there are not enough data from clinical trials to determine the safety and efficacy of digoxin during labor and delivery. studies have shown that digoxin distributes into breast milk and that the milk-to-serum concentration ratio is approximately 0.6-0.9. however, the estimated exposure of a nursing infant to digoxin via breastfeeding is far below the usual infant maintenance dose. therefore, this amount should have no pharmacologic effect upon the infant. the safety and effectiveness of digoxin in the control of ventricular rate in children with atrial fibrillation have not been established. the safety and effectiveness of digoxin 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. table 3 provides 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.

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

cardinal health 107, llc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.25 mg in 1.0 ml - 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 is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is contraindicated in patients with: digoxin should be given to a pregnant woman only if clearly needed.  it is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. animal reproduction studies have not been conducted with digoxin. there are not enough data from clinical trials to determine the safety and efficacy of digoxin during labor and delivery. studies have shown t

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

general injectables and vaccines, inc - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.25 mg in 1 ml - 1.1 heart failure in adults digoxin is indicated for the treatment of mild to moderate heart failure in adults. digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by 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. 1.2 atrial fibrillation in adults digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is 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 cont

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

hikma pharmaceuticals usa inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - 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 is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is 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. digoxin should be given to a pregnant woman only if clearly needed.  it is also not know

Israel - English - Ministry of Health

perrigo israel agencies ltd - digoxin - solution for injection - digoxin 0.5 mg / 2 ml - digoxin - digoxin - for management of chronic cardiac failure,and certain supraventricular arrhythmias.

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

hf acquisition co llc, dba healthfirst - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - 1.1 heart failure in adults 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. 1.2 atrial fibrillation in adults digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is contraindicated in patients with: ventricular fibrillation [see warnings & 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. 8.1 pregnancy pregnancy category c. digoxin should be given to a pregnant woman only if clearly needed. it is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. animal reproduction studies have not been conducted with digoxin. 8.2 labor and delivery there are not enough data from clinical trials to determine the safety and efficacy of digoxin during labor and delivery. 8.3 nursing mothers studies have shown that digoxin distributes into breast milk and that the milk-to-serum concentration ratio is approximately 0.6-0.9. however, the estimated exposure of a nursing infant to digoxin via breastfeeding is far below the usual infant maintenance dose. therefore, this amount should have no pharmacologic effect upon the infant. 8.4 pediatric use the safety and effectiveness of digoxin in the control of ventricular rate in children with atrial fibrillation have not been established. the safety and effectiveness of digoxin 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. 8.5 geriatric use 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 & administration (2.1)]. 8.6 renal impairment the clearance of digoxin can be primarily correlated with the renal function as indicated by creatinine clearance. table 3 provides the usual daily maintenance dose requirements for digoxin based on creatinine clearance [see dosage & 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 & 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. 8.7 hepatic impairment plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects. 8.8 malabsorption the absorption of digoxin is reduced in some malabsorption conditions such as chronic diarrhea.

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

henry schein, inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - 1.1 heart failure in adults digoxin is indicated for the treatment of mild to moderate heart failure in adults. digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by 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. 1.2 atrial fibrillation in adults digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is 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 cont

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

phebra pty ltd - digoxin-specific antibody fragment f(ab) (ovine), quantity: 40 mg - injection, powder for - excipient ingredients: mannitol; sodium acetate - digoxin-specific antibody fragment f(ab) (ovine) digifab is indicated for the treatment of known (or strongly suspected) life-threatening digoxin toxicity associated with ventricular arrhythmias, progressive bradycardia, or second or third degree heart block not responsive to atropine, and where additional measures besides withdrawal of digoxin and correction of serum electrolyte abnormalities are considered necessary. consequences of multiple dosing with digifab have not been evaluated.

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

american health packaging - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 125 ug - digoxin tablets, usp are indicated for the treatment of mild to moderate heart failure in adults. digoxin tablets, usp 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, usp should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin tablets, usp increase myocardial contractility in pediatric patients with heart failure. digoxin tablets, usp 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 ot