DIGOXIN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Amneal Pharmaceuticals of New York LLC

INN (Tên quốc tế):

DIGOXIN

Thành phần:

DIGOXIN 250 ug

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets increase left ventricular ejection fraction and improve 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 tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin tablets increase myocardial contractility in pediatric patients with heart failure. Digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin tablets are 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. Risk Summary Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. Untreated underlying maternal conditions, such as heart failure and atrial fibrillation, during pregnancy pose a risk to the mother and fetus (see Clinical Consideration) . Animal reproduction studies have not been conducted with digoxin. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with heart failure are at increased risk for preterm birth. Clinical classification of heart disease may worsen with pregnancy and lead to maternal or fetal death. Pregnant women with atrial fibrillation are at an increased risk of delivering a low birth weight infant. Atrial fibrillation may worsen with pregnancy and can lead to maternal or fetal death. Fetal/neonatal adverse reactions Digoxin has been shown to cross the placenta and is found in amniotic fluid. Monitor neonates for signs and symptoms of digoxin toxicity, including vomiting, and cardiac arrhythmias [see Warnings and Precautions (5.3)]. Dose adjustments during pregnancy and the postpartum period Digoxin requirements may increase during pregnancy and decrease in the postpartum period. Monitor serum digoxin levels during pregnancy and the postpartum period [see Dosage and Administration (2.5)]. Labor or Delivery Risk of arrhythmias may increase during the labor and delivery. Monitor patients continuously during labor and delivery [see Warnings and Precautions (5.1 and 5.2)]. Risk Summary The digoxin dose received through breastfeeding is up to 4% of the neonatal maintenance dosage, which is unlikely to be clinically relevant. There are no data on the effects of digoxin on the breastfed infant or the effects on milk production. Data Based on data from two lactation studies in a total of 13 breastfed infants, the digoxin concentrations in breast milk were between 0.4 ng/mL to 1.0 ng/mL following 0.25 mg once daily dose of digoxin in the lactating mother. Thus, the amount of digoxin ingested daily by the infants is estimated to be between 0.03 to 0.16 mcg/kg/day. This translates to a relative infant dose of digoxin between 1% to 7% of the maternal weight-adjusted dose and about 0.2% to 4% of the neonatal maintenance dose. The safety and effectiveness of digoxin tablets in the control of ventricular rate in children with atrial fibrillation have not been established. The safety and effectiveness of digoxin tablets 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. Tables 3 and 5 provide 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.

Tóm tắt sản phẩm:

Digoxin tablets USP, 125 mcg (0.125 mg) are light yellow, round, flat-faced beveled edge tablets debossed with “981” on top of bisect on one side and plain on the other side. Bottles of 100:                                                NDC 0115-9811-01 Bottles of 500:                                                NDC 0115-9811-02 Bottles of 1000:                                              NDC 0115-9811-03 Digoxin tablets USP, 250 mcg (0.25 mg) are off-white to light tan, round, convex tablets debossed with “982” on top of bisect on one side and plain on the other side. Bottles of 100:                                                NDC 0115-9822-01 Bottles of 500:                                                NDC 0115-9822-02 Bottles of 1000:                                              NDC 0115-9822-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tightly-closed, light-resistant container as defined in the USP, with child-resistant closure, as required.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DIGOXIN- DIGOXIN TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN TABLETS.
DIGOXIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin tablets are a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart
failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial
fibrillation in adults. (1.3)
DOSAGE AND ADMINISTRATION
Digoxin tablets 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)
DOSAGE FORMS AND STRENGTHS
Scored Tablets 125 mcg and 250 mcg (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 tablets in patients with myocarditis. (5.6)
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. (6.1)
TO REPORT SUSPECTED A