DEMADEX SUMMARY
DEMADEX®
(torsemide)
TABLETS
INJECTION
DEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class.
DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.
DEMADEX intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical.
DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
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NEWS HIGHLIGHTS
Published Studies Related to Demadex (Torsemide)
Torsemide versus furosemide after continuous renal replacement therapy due to acute renal failure in cardiac surgery patients. [2005]
Diuretic therapy in ARF (acute renal failure) is mainly done with loop diuretics, first of all furosemide... Serum creatinine and blood urea nitrogen elimination were less pronounced in the furosemide group.
Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure. [2001.11]
PURPOSE: Because the bioavailability of oral furosemide is erratic and often incomplete, we tested the hypothesis that patients with heart failure who were treated with torsemide, a predictably absorbed diuretic, would have more favorable clinical outcomes than would those treated with furosemide... CONCLUSIONS: Compared with furosemide-treated patients, torsemide-treated patients were less likely to be readmitted for heart failure and for all cardiovascular causes, and were less fatigued. If our results are confirmed by blinded trials, torsemide may be the preferred loop diuretic for patients with chronic heart failure.
Long-term efficacy of torsemide compared with frusemide in cirrhotic patients with ascites. [2001.03]
BACKGROUND: Torsemide is a new loop diuretic that has shown, in short-term studies, to induce a longer and higher diuretic and natriuretic action than frusemide. However, torsemide long-term effects and complications have not been sufficiently investigated. The aim was to compare the efficacy and safety of torsemide versus frusemide in cirrhotic patients with uncomplicated ascites... CONCLUSIONS: These results show that torsemide is as effective and safe as frusemide for long-term treatment of cirrhotic patients with ascites.
Pharmacodynamics of torsemide administered as an intravenous injection and as a continuous infusion to patients with congestive heart failure. [1996.03]
The natriuretic and diuretic effects of a 100-mg dose of torsemide administered as a continuous infusion of torsemide and as a single bolus were compared in a group of patients with stable mild-to-moderate congestive heart failure (CHF). Patients received in random order 100 mg of torsemide as an intravenous bolus and as a 75-mg infusion over 24 hours started simultaneously with a 25-mg loading bolus...
Bioavailability, pharmacokinetics, and pharmacodynamics of torsemide and furosemide in patients with congestive heart failure. [1995.06]
The bioavailability, pharmacokinetics, and pharmacodynamics of torsemide (10 mg orally and intravenously) and furosemide (40 mg orally and 20 mg intravenously) were determined in a randomized crossover clinical trial in 16 patients with compensated congestive heart failure.Assessment of the clinical relevance, if any, of the difference in the variability of absorption warrants further study.
Clinical Trials Related to Demadex (Torsemide)
Bioavailability Study of Torsemide Tablets Under Fed Conditions [Completed]
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Bioavailability Study of Torsemide Tablets Under Fasting Conditions [Completed]
To compare the single-dose bioavailability of Torsemide tablets with Demadex
Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension. [Completed]
Primary objective: To demonstrate the no-inferiority in efficacy of treatment with
Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.
Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.
Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure. [Recruiting]
Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment
of oedema associated to heart failure, kidney or liver disease and either in the treatment of
arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been
developed a new formulation of Torasemide (Torasemide prolonged release).
The aim of this trial is to study the effects of Torasemide prolonged released in comparison
with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart
failure (Class II-IV of the New York Heart Association Classification.
Bioequivalency Study of Torsemide Tablets Under Fasting Conditions [Completed]
The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide
Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a
single-dose, 2-treatment, 2-period, crossover design.
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