Ethacrynic acid

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ethacrynic acid falls into category B. There are no well-done studies that have been done in humans with ethacrynic acid. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

• Diuretics
• High Blood Pressure (Hypertension) Medications

Ethacrynic acid is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.

Ethacrynic acid is used to treat fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome.

Ethacrynic acid may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine after a meal, unless your doctor tells you otherwise.

Ethacrynic acid will make you urinate more often and you may get dehydrated easily. Follow your doctor's instructions about using potassium supplements or getting enough salt and potassium in your diet.

While using ethacrynic acid, you may need frequent blood tests and weight checks.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• digoxin, digitalis;

• lithium;

• blood pressure medications;

• an antibiotic (including those given through an IV);

• a blood thinner--warfarin, Coumadin, Jantoven;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine--prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with ethacrynic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

General

Edema

• Careful etiologic diagnosis should precede the use of any diuretic.b

• Hospitalization of the patient during initiation of therapy is advisable, especially for patients with hepatic cirrhosis and ascites or chronic renal failure.b

• In prolonged diuretic therapy, intermittent use of the drug (e.g., on 2-4 consecutive days each week) may be advisable.b

• For the management of fluid retention associated with heart failure (e.g., edema), experts state that diuretics should be administered at a dosage sufficient to achieve optimal volume status and relieve congestion without inducing an excessively rapid reduction in intravascular volume, which could result in hypotension, renal dysfunction, or both.524

Administration

Administer ethacrynic acid orally. 129 b Administer ethacrynate sodium by IV infusion or slow IV injection.129 b Do not administer ethacrynate sodium sub-Q or IM because of local pain and irritation.129 b

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Use IV administration when a rapid onset of diuresis is desired (e.g., acute pulmonary edema, impaired GI absorption, in patients unable to take the drug orally).129 b

Reconstitute vial containing ethacrynate sodium equivalent to 50 mg of ethacrynic acid with 50 mL of 5% dextrose injection or 0.9% sodium chloride injection to provide a solution containing 1 mg of ethacrynic acid per mL.129 b

Do not use if solution is hazy or opalescent, which may occur if reconstituted with 5% dextrose injection having a pH <5. 129

Infuse slowly over 20–30 minutes through the tubing of a running IV infusionb or by direct IV injection over several minutes.129 b

Dosage

Available as ethacrynic acid and ethacrynate sodium; dosage expressed in terms of ethacrynic acid.129 b

Select dosage carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary.129 (See Electrolyte, Fluid, and Renal Effects under Cautions.)

Weigh patients under standard conditions before initiating and during diuretic therapy.129

Adjust dosage according to patient’s requirements and response.b In adults, use smallest dosage required to produce gradual weight loss of 0.45–0.9 kg (1–2 pounds) daily.129

Some clinicians suggest not to give the drug for more than 2 consecutive days until the patient’s responsiveness is known.b

Pediatric Patients

Hospitalized pediatric patients excluding infants: Initially 25 mg.129 Increase with caution in 25-mg increments daily until desired effect is achieved.129 Once desired response is obtained, may reduce dosage to the minimum required for maintenance.b (See Pediatric Use under Cautions.)

Although manufacturer does not recommend IV use in pediatric patients,129 b some clinicians consider 1-mg/kg doses safe and effective in such patients.b

Adults

Day 1: 50 mg after a meal129 (preferably in the morning).b

Day 2: 50 mg twice daily after meals, if needed.129

Day 3: 100 mg in the morning and 50–100 mg after the noon or evening meal, depending on response to the morning dose.129 b

Some clinicians recommend a dosage of 50 mg daily for several days and then increasing dosage only if necessary.b

Adjust dosage gradually in increments of 25–50 mg daily to avoid alterations in electrolyte and water excretion.129 b Some patients (usually those with severe, refractory edema) may require up to 200 mg twice daily.129

When added to existing diuretic regimen, initial dose should be 25 mg; increase in increments of 25 mg. b

For maintenance therapy, use smallest effective dose once or twice daily.b May reduce frequency of administration after effective diuresis (dry weight) is achieved (usually with doses of 50–100 mg);129 may administer drug intermittently (e.g., on alternate days or less frequently).129 b

Average size adults: 50 mg or 0.5–1 mg/kg; single IV doses should not exceed 100 mg. 129 Usually only one dose is necessary; if a second dose is needed, use a new injection site to avoid possible thrombophlebitis. 129

Initial dosage of 25 mg daily and usual maximum dosage of 100 mg daily (in 2 or 3 divided doses) have been recommended;101 102 103 104 however, other antihypertensive agents are preferred.500 501 502 503 504 (See Hypertension under Uses.)

Prescribing Limits

Adults

Maximum 200 mg twice daily.129

Maximum 100 mg per dose. b

Special Populations

Hepatic Impairment

Initiate therapy in a hospital in cirrhotic patients with ascites. 129

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.129

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bleeding gums
• bloating
• clay-colored stools
• constipation
• darkened urine
• indigestion
• itching
• large, flat, blue or purplish patches in the skin
• loss of appetite
• nausea
• painful knees and ankles
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on skin
• raised red swellings on the skin, the buttocks, legs, or ankles
• skin rash
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

• Anxiety
• black, tarry stools
• blood in urine
• blurred vision
• cold sweats
• coma
• confusion
• convulsions (seizures)
• cool, pale skin
• cough or hoarseness
• depression
• dizziness
• dry mouth
• fast heartbeat
• fever with or without chills
• flushed, dry skin
• fruit-like breath odor
• general feeling of tiredness or weakness
• headache
• increased hunger
• increased thirst
• increased urination
• joint pain, stiffness, or swelling
• lower back, side, or stomach pain
• nausea
• nervousness
• nightmares
• painful or difficult urination
• pale skin
• shakiness
• shortness of breath
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swelling of the feet or lower legs
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• watery and severe diarrhea

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• increase in heart rate
• irregular heartbeat
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• rapid breathing
• sunken eyes
• thirst
• trembling
• weakness and heaviness of the legs
• wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Continuing ringing or buzzing or other unexplained noise in ears
• difficulty swallowing
• fear
• feeling of constant movement of self or surroundings
• feeling of fullness in the ears
• general feeling of discomfort or illness
• hearing loss
• mild diarrhea
• sensation of spinning
• stomach soreness or discomfort
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

(eth a KRIN ik AS id)

• Diuretic, Loop

Frequency not defined.

Cardiovascular: Thrombophlebitis (with intravenous use)

Central nervous system: Apprehension, brain disease (patients with preexisting liver disease), chills, confusion, fatigue, headache, vertigo

Dermatologic: IgA vasculitis (in patient with rheumatic heart disease), skin rash

Endocrine & metabolic: Abnormal phosphorus levels (variations), abnormal serum calcium (variations), gout, hyperglycemia, hyperuricemia (reversible), hypoglycemia (occurred in two uremic patients who received doses above those recommended), hyponatremia, variations in bicarbonate, variations in CO2 content

Gastrointestinal: Abdominal distress, abdominal pain, anorexia, diarrhea, dysphagia, gastrointestinal hemorrhage, malaise, nausea, vomiting, acute pancreatitis (rare)

Genitourinary: Hematuria

Hematologic & oncologic: Agranulocytosis, severe neutropenia, thrombocytopenia

Hepatic: Abnormal hepatic function tests, jaundice

Local: Local irritation, local pain

Ophthalmic: Blurred vision

Otic: Deafness (temporary or permanent), tinnitus

Renal: Increased serum creatinine

Miscellaneous: Fever