Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/342
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EDECRIN (Tablet)
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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.<br/>Oral Use: EDECRIN is available for oral use as 25 mg tablets.<br/>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 once daily 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 : The initial dose
should be 25 mg. Careful stepwise increments in dosage of 25 mg should be
made to achieve effective maintenance.<br/>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 prolongedperiods 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.<br/>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 1.0mg 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.
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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 303.14. Ethacrynic acid is a white,
or practically white, crystalline powder, very slightly soluble in water,
but soluble in most organic solvents such as alcohols, chloroform, and benzene.
Its empirical formula is CHClOand
its structural formula is: Ethacrynate sodium, the sodium salt
of ethacrynic acid, is soluble in water at 25��C to the extent of about
7 percent. Solutions of the sodium salt are relatively stable at about pH
7 at room temperature for short periods, but as the pH or temperature increases
the solutions are less stable. The molecular weight of ethacrynate sodium
is 325.12. Its empirical formula is CHClNaOand
its structural formula is: EDECRIN is supplied as 25 mg tablets
for oral use. The tablets contain the following inactive ingredients: colloidal
silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous
SODIUM EDECRIN(Ethacrynate Sodium) is a sterile
freeze-dried powder and is supplied in a vial containing: Ethacrynate
sodium equivalentto ethacrynic acid...............................................................................50.0
mg Inactive ingredient:Mannitol..............................................................................................62.5
mg
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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 fluid accumulation. Water and electrolyte
excretion may be increased several times over that observed with thiazide
diuretics, since EDECRIN inhibits reabsorption of amuch greater proportion
of filtered sodium than most other diuretic agents. Therefore, EDECRIN is
effective in many patients who have significant degrees of renal insufficiency
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EDECRIN has little or no effect on glomerular filtration or on renal blood
flow, except following pronounced reductions in plasma volume when associated
with rapid diuresis. The electrolyte excretion pattern
of ethacrynic acid varies from that of the thiazides and mercurial diuretics.
Initial sodium and chloride excretion is usually substantial and chloride
loss exceeds that of sodium. With prolonged administration, chloride excretion
declines, and potassium and hydrogen ion excretion may increase. EDECRIN is
effective whether or not there is clinical acidosis or alkalosis. Although
EDECRIN, in carefully controlled studies in animals and experimental subjects,produces a more favorable sodium/potassium excretion ratio than the thiazides,
in patients with increased diuresis excessive amounts of potassium may be
excreted. Onset of action is rapid, usually within 30
minutes after an oral dose of EDECRIN or within 5 minutes after an intravenous
injection of SODIUM EDECRIN. After oral use, diuresis peaks in about 2 hours
and lasts about 6 to 8 hours. The sulfhydryl binding
propensity of ethacrynic acid differs somewhat from that of the organomercurials.
Its mode of action is not by carbonic anhydrase inhibition. Ethacrynic
acid does not cross the blood-brain barrier.
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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 diuretic
should be discontinued. In a few patients this diuretic
has produced severe, watery diarrhea. If this occurs, it should be discontinued
and not used again. Until further experience in infants
is accumulated, therapy with oral and parenteral EDECRIN is contraindicated. Hypersensitivity
to any component of this product.
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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. 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.<br/>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]. MERCK&CO., Inc., Whitehouse Station,
NJ 08889, USA Issued February 2005 Printed
in USA 9350230
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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 lavage performed. Correct dehydration, electrolyte imbalance, hepatic
coma, and hypotension by established procedures. If required, give oxygen
or artificial respiration for respiratory impairment. In
the mouse, the oral LDof ethacrynic acid is 627 mg/kg and the
intravenous LDof ethacrynate sodium is 175 mg/kg.
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ethacrynic acid
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EDECRIN (Tablet)
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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 therapy. A few patients
have had sudden onset of profuse, watery diarrhea. Discontinue EDECRIN if
diarrhea is severe and do not give it again. Gastrointestinal bleeding has
occurred in some patients. Rarely, acute pancreatitis has been reported.<br/>Metabolic: Reversible hyperuricemia and acute gout have been reported.
Acute symptomatic hypoglycemia with convulsions occurred in two uremic patients
who received doses above those recommended. Hyperglycemia has been reported.
Rarely, jaundice and abnormal liver function tests have been reported in seriously
ill patients receiving multiple drug therapy, including EDECRIN.<br/>Hematologic: Agranulocytosis or severe neutropenia has been reported in
a few critically ill patients also receiving agents known to produce this
effect. Thrombocytopenia has been reported rarely. Henoch-Sch��nlein purpura
has been reported rarely in patients with rheumatic heart disease receiving
multiple drug therapy, including EDECRIN.<br/>Special Senses: Deafness,
tinnitus and vertigo with a sense of fullness in the ears, and blurred vision
have occurred.<br/>Central Nervous System: Headache, fatigue, apprehension, confusion.<br/>Miscellaneous: Skin rash, fever, chills, hematuria. SODIUM
EDECRIN occasionally has caused local irritation and pain after intravenous
use.
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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 throughout
the treatment period, by careful adjustment of dosage, by initiating treatment
with small doses, and by using the drug on an intermittent schedule when possible.
When excessive diuresis occurs, the drug should be withdrawn until homeostasis
is restored. When excessive electrolyte loss occurs, the dosage should be
reduced or the drug temporarily withdrawn. Initiation
of diuretic therapy with EDECRIN in the cirrhotic patient with ascites is
best carried out in the hospital. When maintenance therapy has been established,
the individual can be satisfactorily followed as an outpatient. EDECRIN
should be given with caution to patients with advanced cirrhosis of the liver,
particularly those with a history of previous episodes of electrolyte imbalance
or hepatic encephalopathy. Like other diuretics it may precipitate hepatic
coma and death. Too vigorous a diuresis, as evidenced
by rapid and excessive weight loss, may induce an acute hypotensive episode.
In elderly cardiac patients, rapid contraction of plasma volume and the resultant
hemoconcentration should be avoided to prevent the development of thromboembolic
episodes, such as cerebral vascular thromboses and pulmonary emboli which
may be fatal. Excessive loss of potassium in patients receiving digitalis
glycosides may precipitate digitalis toxicity. Care should also be exercised
in patients receiving potassium-depleting steroids. A
number of possibly drug-related deaths have occurred in critically ill patients
refractory to other diuretics. These generally have fallen into two categories:
(1) patients with severe myocardial disease who have been receiving digitalis
and presumably developed acute hypokalemia with fatal arrhythmia; (2) patients
with severely decompensated hepatic cirrhosis with ascites, with or without
accompanying encephalopathy, who were in electrolyte imbalance and died because
of intensification of the electrolyte defect. Deafness,
tinnitus, and vertigo with a sense of fullness in the ears have occurred,
most frequently in patients with severe impairment of renal function. These
symptoms have been associated most often with intravenous administration and
with doses in excess of those recommended. The deafness has usually been reversible
and of short duration (one to 24 hours). However, in some patients the hearing
loss has been permanent. A number of these patients were also receiving drugs
known to be ototoxic. EDECRIN may increase the ototoxic potential of other
drugs . Lithium
generally should not be given with diuretics (see PRECAUTIONS,
Drug Interactions).
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EDECRIN is indicated for treatment of edema when an agent
with greater diuretic potential than those commonly employed is required.
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EDECRIN
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