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.

General: DEMADEX tablets may be given at any time in relation to a meal, as convenient. Special dosage adjustment in the elderly is not necessary.

Because of the high bioavailability of DEMADEX, oral and intravenous doses are therapeutically equivalent, so patients may be switched to and from the intravenous form with no change in dose. DEMADEX intravenous injection should be administered either slowly as a bolus over a period of 2 minutes or administered as a continuous infusion.

If DEMADEX is administered through an IV line, it is recommended that, as with other IV injections, the IV line be flushed with Normal Saline (Sodium Chloride Injection, USP) before and after administration. DEMADEX injection is formulated above pH 8.3. Flushing the line is recommended to avoid the potential for incompatibilities caused by differences in pH which could be indicated by color change, haziness or the formation of a precipitate in the solution.

If DEMADEX is administered as a continuous infusion, stability has been demonstrated through 24 hours at room temperature in plastic containers for the following fluids and concentrations:

200 mg DEMADEX (10 mg/mL) added to:
    250 mL Dextrose 5% in water
    250 mL 0.9% Sodium Chloride
    500 mL 0.45% Sodium Chloride50 mg DEMADEX (10 mg/mL) added to:
    500 mL Dextrose 5% in water
    500 mL 0.9% Sodium Chloride
    500 mL 0.45% Sodium Chloride

Before administration, the solution of DEMADEX should be visually inspected for discoloration and particulate matter. If either is found, the ampul should not be used.

Congestive Heart Failure: The usual initial dose is 10 mg or 20 mg of once-daily oral or intravenous DEMADEX. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.

Chronic Renal Failure: The usual initial dose of DEMADEX is 20 mg of once-daily oral or intravenous DEMADEX. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.

Hepatic Cirrhosis: The usual initial dose is 5 mg or 10 mg of once-daily oral or intravenous DEMADEX, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied.

Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.

Hypertension: The usual initial dose is 5 mg once daily. If the 5 mg dose does not provide adequate reduction in blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive agent should be added to the treatment regimen.

DEMADEX for oral administration is available as white, scored tablets containing 5 mg, 10 mg, 20 mg, or 100 mg of torsemide.

The tablets are supplied in bottles and Tel-E-Dose^®* packages of 100 as follows:

Each tablet is debossed on the scored side with the Boehringer Mannheim logo and 102, 103, 104, or 105 (for 5 mg, 10 mg, 20 mg, or 100 mg, respectively). On the opposite side, the tablet is debossed with 5, 10, 20, or 100 to indicate the dose.

DEMADEX for intravenous injection is supplied in clear ampuls containing 2 mL (20 mg, NDC 0004-0267-06) or 5 mL (50 mg, NDC 0004-0268-06) of a 10 mg/mL sterile solution. The ampuls are supplied in boxes of 10.

Storage: Store all dosage forms at 15° to 30°C (59° to 86°F). Do not freeze.

*Tel-E-Dose is a registered trademark of Hoffmann-La Roche Inc.Rx only

Distributed by:
Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199

27897544-0401      
Revised: April 2001
Printed in USA
Copyright © 1998-2001 by Roche Laboratories Inc. All rights reserved.
Copyright © 2001 Hoffmann-La Roche Inc. All rights reserved.

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