DIGOXIN injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

HF Acquisition Co LLC, DBA HealthFirst

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

DIGOXIN INJECTION, USP is supplied in the following dosage forms. NDC 51662-1217-1 DIGOXIN INJECTION, USP 500mcg/2mL 0.5/2mL (250mcg/mL) AMP NDC 51662-1217-2 Pouch containing a single DIGOXIN INJECTION, USP 500mcg/2mL 0.5/2mL (250mcg/mL) AMP NDC 51662-1217-3 Case of 25 pouches - DIGOXIN INJECTION, USP 500mcg/2mL 0.5/2mL (250mcg/mL) AMP HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms Digoxin Injection, USP is available as: 500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s (NDC 0641-1410-35) Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [see USP Controlled Room Temperature]. Protect from light.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DIGOXIN- DIGOXIN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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DIGOXIN INJECTION, USP 500MCG/2ML 0.5/2ML (250MCG/ML) AMP
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 to