DIGOXIN injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)

Tilgængelig fra:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DIGOXIN

Sammensætning:

DIGOXIN 0.25 mg in 1 mL

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Digoxin Injection, USP is available as: 500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s (NDC 0641-1410-35) Store at 20˚ to 25˚C (68˚ to 77˚F), excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Protect from light.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DIGOXIN- DIGOXIN INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN
INJECTION.
DIGOXIN INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin is a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Control of resting ventricular rate in adults with chronic atrial
fibrillation. (1.2)
DOSAGE AND ADMINISTRATION
Digoxin dose is based on patient-specific factors (age, lean body
weight, renal function, etc.). See full
prescribing information. Monitor for toxicity and therapeutic effect.
(2)
Intravenous administration is preferable to intramuscular. Avoid bolus
administration. (2)
DOSAGE FORMS AND STRENGTHS
Digoxin Injection: Ampuls containing 500 mcg (0.5 mg) in 2 mL. (3)
CONTRAINDICATIONS
Ventricular fibrillation. (4)
Known hypersensitivity to digoxin or other forms of digitalis. (4)
WARNINGS AND PRECAUTIONS
Risk of rapid ventricular response leading to ventricular fibrillation
in patients with AV accessory
pathway. (5.1)
Risk of advanced or complete heart block in patients with sinus node
disease and AV block. (5.2)
Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances,
and cardiac arrhythmias. Advanced
age, low body weight, impaired renal function and electrolyte
abnormalities predispose to toxicity. (5.3)
Risk of ventricular arrhythmias during electrical cardioversion. (5.4)
Not recommended in patients with acute myocardial infarction (5.5)
Avoid digoxin in patients with myocarditis. (5.6)
ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5-20%, with 15-20% of
adverse events considered serious. Cardiac toxicity accounts for about
one-half, gastrointestinal
disturbances for about one-fourth, and CNS and other toxicity for
about one-fourth of these adverse
events. (6.1)
TO REPO