Hoa Kỳ - Tiếng Anh - 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

Hoa Kỳ - Tiếng Anh - 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.

Hoa Kỳ - Tiếng Anh - 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

Hoa Kỳ - Tiếng Anh - 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

Israel - Tiếng Anh - 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.

Úc - Tiếng Anh - 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.

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

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

Canada - Tiếng Anh - Health Canada

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

Úc - Tiếng Anh - 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.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

aspen pharma pty ltd - digoxin, quantity: 25 microgram/ml - injection, solution - excipient ingredients: ethanol; propylene glycol; citric acid; dibasic sodium phosphate; water for injections - 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.