Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Digoxin (UNII: 73K4184T59) (Digoxin - UNII:73K4184T59)
Precision Dose Inc.
Digoxin
Digoxin 0.05 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
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 Baca dokumen lengkap