EDECRIN (Page 3 of 3)

Maintenance Therapy

It is usually possible to reduce the dosage and frequency of administration once dry weight has been achieved.

EDECRIN (Ethacrynic Acid) may be given intermittently after an effective diuresis is obtained with the regimen outlined above. Dosage may be on an alternate daily schedule or more prolonged periods of diuretic therapy may be interspersed with rest periods. Such an intermittent dosage schedule allows time for correction of any electrolyte imbalance and may provide a more efficient diuretic response.

The chloruretic effect of this agent may give rise to retention of bicarbonate and a metabolic alkalosis. This may be corrected by giving chloride (ammonium chloride or arginine chloride). Ammonium chloride should not be given to cirrhotic patients.

EDECRIN has additive effects when used with other diuretics. For example, a patient who is on maintenance dosage of an oral diuretic may require additional intermittent diuretic therapy, such as an organomercurial, for the maintenance of basal weight. The intermittent use of EDECRIN orally may eliminate the need for injections of organomercurials. Small doses of EDECRIN may be added to existing diuretic regimens to maintain basal weight. This drug may potentiate the action of carbonic anhydrase inhibitors, with augmentation of natriuresis and kaliuresis. Therefore, when adding EDECRIN the initial dose and changes of dose should be in 25 mg increments, to avoid electrolyte depletion. Rarely, patients who failed to respond to ethacrynic acid have responded to older established agents.

While many patients do not require supplemental potassium, the use of potassium chloride or potassium-sparing agents, or both, during treatment with EDECRIN is advisable, especially in cirrhotic or nephrotic patients and in patients receiving digitalis.

Salt liberalization usually prevents the development of hyponatremia and hypochloremia. During treatment with EDECRIN, salt may be liberalized to a greater extent than with other diuretics. Cirrhotic patients, however, usually require at least moderate salt restriction concomitant with diuretic therapy.

Intravenous Use

Intravenous SODIUM EDECRIN is for intravenous use when oral intake is impractical or in urgent conditions, such as acute pulmonary edema.

The usual intravenous dose for the average sized adult is 50 mg, or 0.5 to 1.0 mg per kg of body weight. Usually only one dose has been necessary; occasionally a second dose at a new injection site, to avoid possible thrombophlebitis, may be required. A single intravenous dose not exceeding 100 mg has been used in critical situations.

Insufficient pediatric experience precludes recommendation for this age group.

To reconstitute the dry material, add 50 mL of 5 percent Dextrose Injection, or Sodium Chloride Injection to the vial. Occasionally, some 5 percent Dextrose Injection solutions may have a low pH (below 5). The resulting solution with such a diluent may be hazy or opalescent. Intravenous use of such a solution is not recommended. Inspect the vial containing Intravenous SODIUM EDECRIN for particulate matter and discoloration before use.

The solution may be given slowly through the tubing of a running infusion or by direct intravenous injection over a period of several minutes. Do not mix this solution with whole blood or its derivatives. Discard unused reconstituted solution after 24 hours.

SODIUM EDECRIN should not be given subcutaneously or intramuscularly because of local pain and irritation.

HOW SUPPLIED

Tablets EDECRIN, 25 mg, are white, capsule shaped, scored tablets, coded VRX 205 on one side and EDECRIN on the other. They are supplied as follows:

  • NDC 0179-0126-70 in Unit Dose Box of 30.

Storage

Store in a tightly closed container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Tablets EDECRIN® (Ethacrynic Acid)
manufactured for:

Aton Pharma, Inc. (division of Valeant
Pharmaceuticals North America LLC)
Bridgewater, NJ 08807

by:
Valeant Pharmaceuticals International, Inc.
Steinbach, MB R5G 1Z7
Canada

COPYRIGHT © 2011 ATON PHARMA, INC.:
(division of Valeant Pharmaceuticals North
America LLC)
All rights reserved

November 2011
LB0089-00

Repackaged by:
KAISER FOUNDATION HOSPITALS
Livermore, CA 94551

PRINCIPAL DISPLAY PANEL — 25 mg Label

Edecrin ®
(Ethacrynic Acid)

25 mg

Manufactured by:
Valeant Pharmaceuticals International, Inc.
Steinbach, MB R5G 1Z7 Canada

Each tablet contains 25 mg of ethacrynic
acid. Store in a tightly closed container at
25° C (77° F); excursions permitted to
15-30° C (59-86° F).
[See USP Controlled Room Temperature]

30 Unit DoseTablets

Repackaged by:
KAISER FOUNDATION HOSPITALS Livermore, CA 94551

Principal Display Panel -- 25 mg Label
(click image for full-size original)
EDECRIN ethacrynic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0126(NDC:25010-215)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHACRYNIC ACID (ETHACRYNIC ACID) ETHACRYNIC ACID 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE, UNSPECIFIED FORM (ANHYDROUS LACTOSE)
MAGNESIUM STEARATE
TALC
Product Characteristics
Color white Score 2 pieces
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code VRX;205;EDECRIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0179-0126-70 30 TABLET in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016092 01/10/2013 02/28/2019
Labeler — KAISER FOUNDATION HOSPITALS (053052619)
Establishment
Name Address ID/FEI Operations
KAISER FOUNDATION HOSPITALS 053052619 repack (0179-0126)

Revised: 11/2018 KAISER FOUNDATION HOSPITALS

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