DIGOXIN- digoxin solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

Digoxin (UNII: 73K4184T59) (Digoxin - UNII:73K4184T59)

Beszerezhető a:

Precision Dose Inc.

INN (nemzetközi neve):

Digoxin

Összetétel:

Digoxin 0.05 mg in 1 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Digoxin Oral Solution, USP 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 increased exercise capacity and decreased 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. Digoxin increases myocardial contractility in pediatric patients with heart failure. Digoxin Oral Solution, USP is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation. Digoxin should not be used for the treatment of multifocal atrial tachycardia. Allergy to digoxin is rare. Digoxin is contraindicated in patients with a known hypersensitivity to digoxin or other forms of digitalis. Digitalis glycosides, such as digoxin, are contraindicated in ventricula

Termék összefoglaló:

Digoxin Oral Solution, USP 0.05 mg (50 mcg) per 1 mL is a clear, colorless solution available in one strength as follows: 0.05 mg per 1mL Oral Solution NDC 68094-751-62 2.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-752-62 5 mL per unit dose cup Thirty (30) cups per shipper Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

DIGOXIN- DIGOXIN SOLUTION
PRECISION DOSE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN ORAL SOLUTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN ORAL
SOLUTION, USP.
DIGOXIN ORAL SOLUTION, USP
INITIAL U.S. APPROVAL : 1982
INDICATIONS AND USAGE
In adults, digoxin is indicated for the treatment of mild to moderate
heart failure and for the control of resting ventricular
rate in patients with chronic atrial fibrillation. (1) In pediatric
patients with heart failure, digoxin increases myocardial
contractility.
DOSAGE AND ADMINISTRATION
Toxic levels of digoxin are only slightly higher than therapeutic
levels. The pharmacokinetics of digoxin are complex and
dose determination should take into account patient-specific factors
(age, lean body weight, renal function, etc.). (2.4)(2.5)
Patients should be monitored for toxicity and therapeutic effect and
doses should be adjusted, accordingly. (2.2)
DOSAGE FORMS AND STRENGTHS
Oral Solution: Each 1 mL contains 0.05 mg (50 mcg) of digoxin. (3)
CONTRAINDICATIONS
Known hypersensitivity to digoxin or other forms of digitalis. (4)
Ventricular fibrillation. (4)
WARNINGS AND PRECAUTIONS
Accessory AV Pathway: Increased risk of rapid ventricular response
leading to ventricular fibrillation. (5.1)
Sinus node disease and AV block: Digoxin use can exacerbate the
condition and may cause advanced or complete heart
block. (5.2)
Misidentification of digoxin toxicity: Signs and symptoms of digoxin
toxicity may be mistaken for worsening symptoms
of congestive heart failure. (5.3)
Preserved left ventricular systolic function: Patients with heart
failure with preserved left ventricular ejection fraction
may be more susceptible to digoxin toxicity. (5.4)
Impaired renal function: Renal impairment results in increased digoxin
exposure and requires dosage adjustments.
(5.5)
Electrolyte disorders: Toxicity is increased by hypokalemia,
hypomagnesemia, and hypercalcemia. (5.6)
Hypermetabolic s