EDECRIN Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

25010-215 25010-210

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BOXED WARNING SECTION

EDECRIN (ethacrynic acid) is a potent diuretic which, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, ...

1. Description

Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of ...

2. Clinical Pharmacology

Pharmacokinetics and Metabolism EDECRIN acts on the ascending limb of the loop of Henle and on the proximal and distal tubules. Urinary output is usually dose dependent and related to the magnitude of ...

3. Indications and Usage

EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. Treatment of the edema associated with congestive heart failure, cirrhosis ...

4. Contraindications

All diuretics, including ethacrynic acid, are contraindicated in anuria. If increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the ...

5. Warnings

The effects of EDECRIN on electrolytes are related to its renal pharmacologic activity and are dose dependent. The possibility of profound electrolyte and water loss may be avoided by weighing the patient ...

6.1. General

Weakness, muscle cramps, paresthesias, thirst, anorexia, and signs of hyponatremia, hypokalemia, and/or hypochloremic alkalosis may occur following vigorous or excessive diuresis and these may be accentuated ...

6.3. Laboratory Tests

Frequent serum electrolyte, CO2 and BUN determinations should be performed early in therapy and periodically thereafter during active diuresis. Any electrolyte abnormalities should be corrected ...

6.4. Drug Interactions

Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of a tumorigenic effect in a 79-week oral chronic toxicity study in rats at doses up to 45 times the human dose. Ethacrynic acid had no effect on fertility in a two-litter study in ...

6.7. Pregnancy

Reproduction studies in the mouse and rabbit at doses up to 50 times the human dose showed no evidence of external abnormalities of the fetus due to EDECRIN. In a two-litter study in the dog and rat, oral ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from EDECRIN, a ...

6.10. Pediatric Use

There are no well-controlled clinical trials in pediatric patients. The information on oral dosing in pediatric patients, other than infants, is supported by evidence from empiric use in this age group. ...

6.11. Geriatric Use

Of the total number of subjects in clinical studies of EDECRIN/SODIUM EDECRIN, approximately 224 patients (21%) were 65 to 74 years of age, while approximately 100 patients (9%) were 75 years of age and ...

7. Adverse Reactions

Gastrointestinal Anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting, and diarrhea have occurred. These are more frequent with large doses or after one to three months of continuous ...

9. Overdosage

Overdosage may lead to excessive diuresis with electrolyte depletion and dehydration. In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric ...

10. Dosage and Administration

Dosage must be regulated carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary. The magnitude of diuresis and natriuresis is largely dependent ...

11. 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 25010-215-15 in bottles of 100. Intravenous SODIUM ...

12. Storage and Handling

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