nce-daily oral 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 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.
HOW SUPPLIED
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 of 100 as follows:
Dose Shape Bottle
5 mg elliptical NDC 0037-5005-01
10 mg elliptical NDC 0037-5010-01
20 mg elliptical NDC 0037-5020-01
100 mg capsule shaped NDC 0037-5001-01
Each tablet is debossed on the scored side with the logo BM 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.
Storage
Store at 15° to 30°C (59° to 86°F).
Rx only
Manufactured By: Roche Farma S.A., Leganes Spain
For: Meda Pharmaceuticals
Meda Pharmaceuticals Inc.
Somerset, NJ 08873-4120
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Printed in USA
©2009 Meda Pharmaceuticals Inc.
IN-0455-02 Rev. 5/09
Package Label - Principal Display Panel – 100-Count Bottle, 5 mg Tablets
NDC 0037-5005-01
100 Tablets
DEMADEX®
(torsemide)
5 mg Rx only
Meda Pharmaceuticals™
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
Dispense in tight containers as defined by USP/NF.
Store at 15°-30°C (59°-86°F).
MADE IN SPAIN
LB-455050-01
Rev. 10/08
Each tablet contains 5 mg torsemide.
Usual dosage: See package insert.
Manufactured by:
Roche Farma S.A. Leganes, Spain
for Meda Pharmaceuticals Inc.
Package Label - Principal Display Panel – 100-Count Bottle, 10 mg Tablets
NDC 0037-5010-01
100 Tablets
DEMADEX®
(torsemide)
10 mg Rx only
Meda Pharmaceuticals™
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
Dispense in tight containers as defined by USP/NF.
Store at 15°-30°C (59°-86°F).
MADE IN SPAIN
LB-455101-01
Rev. 10/08
Each tablet contains 10 mg torsemide.
Usual dosage: See package insert.
Manufactured by:
Roche Farma S.A. Leganes, Spain
for Meda Pharmaceuticals Inc.
Package Label - Principal Display Panel – 100-Count Bottle, 20 mg Tablets
NDC 0037-5020-01
100 Tablets
DEMADEX®
(torsemide)
2
