INDICATIONS
EDECRIN is indicated for treatment of edema when an agent
with greater diuretic potential than those commonly employed
is required.
1. Treatment of the edema associated with congestive
heart failure, cirrhosis of the liver, and renal disease,
including the nephrotic syndrome.
2. Short- term management of ascites due to malignancy,
idiopathic edema, and lymphedema.
3. Short- term management of hospitalized pediatric patients,
other than infants, with congenital heart disease or the
nephrotic syndrome.
4. Intravenous SODIUM EDECRIN is indicated when a rapid
onset of diuresis is desired, e.g., in acute pulmonary
edema, or when gastrointestinal absorption is impaired
or oral medication is not practicable.
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 on the degree of fluid
accumulation present in the patient. Similarly, the extent
of potassium excretion is determined in large measure
by the presence and magnitude of aldosteronism.
Oral Use
EDECRIN is available for oral use as 25 mg and 50 mg
tablets.
Dosage: To Initiate Diuresis
In Adults: The smallest dose required
to produce gradual weight loss (about 1 to 2 pounds per
day) is recommended. Onset of diuresis usually occurs
at 50 to 100 mg for adults. After diuresis has been achieved,
the minimally effective dose (usually from 50 to 200 mg
daily) may be given on a continuous or intermittent dosage
schedule. Dosage adjustments are usually in 25 to 50 mg
increments to avoid derangement of water and electrolyte
excretion.
The patient should be weighed under standard conditions
before and during the institution of diuretic therapy with
this compound. Small alterations in dose should effectively
prevent a massive diuretic response. The following schedule
may be helpful in determining the smallest effective dose.
Day 1 — 50 mg (single dose) after a meal
Day 2 — 50 mg twice daily after meals, if necessary
Day 3 — 100 mg in the morning and 50 to 100 mg following
the afternoon or evening meal, depending upon response
to the morning dose.
A few patients may require initial and maintenance doses
as high as 200 mg twice daily. These higher doses, which
should be achieved gradually, are most often required
in patients with severe, refractory edema.
In Pediatric Patients (excluding infants, see CONTRA
INDICATIONS
): The initial dose should be 25 mg. Careful stepwise
increments in dosage of 25 mg should be made to achieve
effective maintenance.
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
No. 3321 — Tablets EDECRIN, 25 mg, are white, capsule
shaped, scored tablets, coded MSD 65 on one side and EDECRIN
on the other. They are supplied as follows:
NDC 0006-0065-68 in bottles of 100.
No. 3322 — Tablets EDECRIN, 50 mg, are green, capsule
shaped, scored tablets, coded MSD 90 on one side and EDECRIN
on the other. They are supplied as follows:
NDC 0006-0090-68 in bottles of 100
(6505-00-834-0473,50 mg bottles of 100).
No. 3620 — Intravenous SODIUM EDECRIN is a dry
white material either in a plug form or as a powder. It
is supplied in vials containing ethacrynate sodium equivalent
to 50 mg of ethacrynic acid, NDC 0006-3620-50.
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