LANOXICAPS SUMMARY
LANOXICAPS® (digoxin solution in capsules) mcg (0.1 mg) I.D. Imprint B2C (yellow) 200 mcg (0.2 mg) I.D. Imprint C2C (green)
LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence“glycosides”).
Heart Failure
LANOXIN is indicated for the treatment of mild to moderate heart failure. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these 3 drugs cannot be specified.
Atrial Fibrillation
LANOXIN is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.
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NEWS HIGHLIGHTSMedia Articles Related to Lanoxicaps (Digoxin)
Heart Drug Digoxin May Raise Death Risk for Some Patients: Study Source: MedicineNet digoxin Specialty [2017.03.23] Title: Heart Drug Digoxin May Raise Death Risk for Some Patients: Study Category: Health News Created: 3/22/2017 12:00:00 AM Last Editorial Review: 3/23/2017 12:00:00 AM
Congestive Heart Failure (CHF) Symptoms, Stages, and Prognosis Source: MedicineNet Amyloidosis Specialty [2017.08.11] Title: Congestive Heart Failure (CHF) Symptoms, Stages, and Prognosis Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 8/11/2017 12:00:00 AM
Published Studies Related to Lanoxicaps (Digoxin)
Darexaban (YM150), an oral direct factor Xa inhibitor, has no effect on the
pharmacokinetics of digoxin. [2014] To investigate the impact of the direct Factor Xa inhibitor darexaban
administered in a modified-release formulation (darexaban-MR) on the
pharmacokinetic (PK) profile of digoxin. In this Phase I, randomized,
double-blind, two-period crossover study (8 days for each treatment, 10 days
washout), 24 healthy subjects received darexaban-MR 120 mg once/day (qd) +
digoxin 0.25 mg qd in one treatment period, and placebo + digoxin 0.25 mg qd in
the other treatment period...
Effect of lacosamide on the steady-state pharmacokinetics of digoxin: results
from a phase I, multiple-dose, double-blind, randomised, placebo-controlled,
crossover trial. [2014] with lacosamide or placebo... CONCLUSION: Co-administration of steady-state digoxin (0.25 mg/day) with
The study of antiarrhythmic medications in infancy (SAMIS): a multicenter,
randomized controlled trial comparing the efficacy and safety of digoxin versus
propranolol for prophylaxis of supraventricular tachycardia in infants. [2012] CONCLUSIONS: There was no difference in SVT recurrence in infants treated with
Evaluation of the pharmacokinetic interaction after multiple oral doses of linagliptin and digoxin in healthy volunteers. [2011.03] The aim of this study was to investigate whether multiple doses of the oral and highly selective dipeptidyl peptidase-4 inhibitor linagliptin affect the steady-state pharmacokinetics of the P-glycoprotein substrate digoxin. This single-center, open-label, two-period cross-over study involved healthy subjects (n = 20), randomized to treatment sequence AB or BA, where A comprised 0.25 mg digoxin qd for 5 days, then 0.25 mg digoxin qd plus 5 mg linagliptin qd for 6 days, and B comprised 0.25 mg digoxin qd for 11 days...
Digoxin for preventing or treating neonatal respiratory distress syndrome. [2011.01.19] CONCLUSIONS: Although hemodynamic disturbances play a role in the overall pathogenesis of respiratory distress syndrome, the specific contribution of early congestive heart failure (unrelated to hemodynamically significant patent ductus arteriosus) does not appear to be a significant factor in RDS. Treatment with digoxin has no proven value in infants solely affected with RDS.
Clinical Trials Related to Lanoxicaps (Digoxin)
Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care [Completed]
Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in
decades despite evidence in recent years suggesting that blood levels of digoxin achieved
with traditional dosing practices may increase the risk of adverse events. We developed a
simple dosing tool that targets lower blood levels of digoxin that have been associated with
improved outcomes compared to higher blood levels. The aim of this study is to determine if
this simplified dosing tool is more effective than standard digoxin dosing practices at
achieving lower blood levels and also to determine if digoxin dosing may be further
optimized by incorporating patients' genetic information believed to influence the drug's
properties.
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects [Completed]
The purpose of this study is to evaluate the effect of steady state solifenacin and
mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will
also evaluate the safety and tolerability of the combined steady state administration of
solifenacin, mirabegron and digoxin.
Drug Interaction Study of Isavuconazole and Digoxin [Completed]
A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults [Completed]
The primary objective of this study is to determine the effect of repeat oral doses of
eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the
pharmacokinetics (PK) of orally administered digoxin 0. 25 mg in healthy adult subjects. This
will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects.
The study will comprise a screening period (between Day - 45 and Day -2), treatment period 1
(Day - 1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day
24 ± 1). There will be a 10-day washout between dosing of study drug in Period 1 and Period
2. The duration of each subject's participation in the study, inclusive of the screening and
follow-up visits, will be approximately 10 weeks.
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers [Completed]
The aim of this trial is to investigate the effect of multiple doses of flibanserin on the
single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a
narrow therapeutic index drug for which a large number of relevant drug-drug interactions
are known. Flibanserin is now under evaluation in postmenopausal women which increases the
likelihood that flibanserin and digoxin will be administered together in the clinical
setting.
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