DIGOXIN solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Hikma Pharmaceuticals USA Inc.

INN (Medzinárodný Name):

DIGOXIN

Zloženie:

DIGOXIN 0.05 mg in 1 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Digoxin Oral Solution 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 is indicated to increase myocardial contractility in pediatric patients with heart failure. Digoxin Oral Solution 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 ventricular fibrillation. Teratogenic Effects Animal reproduction studies have not been conducted with digoxin. It is also not known whether digoxin can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Digoxin should be given to a pregnant woman only if clearly needed. There is not enough data from clinical trials to determine the safety and efficacy of digoxin during labor and delivery. Digoxin levels in human milk are lower than those in maternal serum. The estimated exposure that a nursing infant would be expected to receive via breastfeeding would be far below the usual infant maintenance dose. Therefore, this amount should have no pharmacologic effect upon the infant. Nevertheless, caution should be exercised when digoxin is administered to a nursing woman. Digoxin increases myocardial contractility in pediatric patients with congestive heart failure. There are no clinical efficacy studies demonstrating benefit in pediatric patients with heart failure. There are no controlled randomized studies of digoxin in pediatric patients with atrial tachyarrhythmias [see Clinical Studies (14.2)] . 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 (2.4)] . No clinically significant gender differences in digoxin pharmacokinetics have been reported. The clearance of digoxin can be primarily correlated with renal function as indicated by creatinine clearance. Table 3 provides the usual daily maintenance dose requirements of solution based on creatinine clearance (per 70 kg or per 1.73 m2 ) [see Dosage and Administration (2.4) ]. For pediatric patients with known or suspected renal dysfunction, lower starting doses should be considered combined with frequent monitoring of digoxin levels. Plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects. In hyperthyroidism, lower serum digoxin concentrations have been reported because of decreased absorption. Hypothyroid patients may require smaller doses of digoxin. Race differences in digoxin pharmacokinetics have not been formally studied, but are not expected. The absorption of digoxin is reduced in some malabsorption conditions such as chronic diarrhea. INSTRUCTIONS FOR USE Digoxin Oral Solution, USP Oral Syringe Important information about measuring Digoxin Oral Solution 1. Insert the tip of the oral syringe into the medicine bottle. 2. Pull back the plunger to the line that matches the dose prescribed by your healthcare provider. 3. Remove the oral syringe from the medicine bottle. 4. Take your medicine by slowly pushing the plunger until the oral syringe is empty. Figure 1 Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000480/01 Revised August 2023

Prehľad produktov:

Digoxin Oral Solution, USP 0.05 mg (50 mcg) per 1 mL is supplied as a (lime-flavored) clear, colorless solution. NDC 0054-0057-46: Bottle of 60 mL with a calibrated oral syringe Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

DIGOXIN- DIGOXIN SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN ORAL SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN
ORAL SOLUTION.
DIGOXIN ORAL SOLUTION
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Digoxin is a cardiac glycoside indicated in adults for the treatment
of mild to moderate heart failure and
for the control of resting ventricular rate in patients with chronic
atrial fibrillation. (1.1, 1.3) In pediatric
patients with heart failure, digoxin is indicated to increase
myocardial contractility. (1.2)
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
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5% to 20%, with 15% to 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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Known hypersensitivity to digoxin or other forms of digitalis. (4)
Ventricular fibrillation. (4)
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 o