Pronunciation:

eth-a-KRIN-ik AS-id

Brand Names:

• Edecrin

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Diuretic, Loop

Uses of This Medicine:

Ethacrynic acid belongs to a group of medicines called loop diuretics or "water pills." Ethacrynic acid is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ethacrynic acid in children below 2 years of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ethacrynic acid in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dosage in patients receiving ethacrynic acid .

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Albuterol
• Amikacin
• Amikacin Liposome
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Bepridil
• Bromfenac
• Bufexamac
• Buprenorphine
• Celecoxib
• Choline Salicylate
• Clonixin
• Codeine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Dipyrone
• Dofetilide
• Droperidol
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Foscarnet
• Furosemide
• Gentamicin
• Ibuprofen
• Indomethacin
• Kanamycin
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Lithium
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metolazone
• Morniflumate
• Nabumetone
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oliceridine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sotalol
• Streptomycin
• Sufentanil
• Sulindac
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Tramadol
• Valdecoxib
• Vonoprazan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Benazepril
• Captopril
• Cilazapril
• Cortisone
• Enalapril
• Enalaprilat
• Fosinopril
• Germanium
• Ginseng
• Gossypol
• Licorice
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Trandolapril
• Zofenopril

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anuria (not able to form urine) or
• Electrolyte imbalance (low or high amounts of minerals in the blood), severe or
• Watery diarrhea, severe—Should not use in patients with these conditions .

• Diabetes—This medicine may increase the amount of sugar in the blood .

• Hearing problems or
• Hypochloremia (low chloride in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Hypovolemia (low blood volume) or
• Liver disease (cirrhosis), advanced—Use with caution. This medicine may make these conditions worse .

• Hypoproteinemia (low protein in the blood)—May decrease the effect of the medicine in the body .

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of This Medicine:

It is best to take this medicine after meals .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For edema:
    • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children 2 to 18 years of age—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children below 2 years of age—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. You may also need to weigh yourself daily and record your weight .

This medicine may cause you to lose more potassium from your body than normal. Your doctor will monitor the potassium in your blood while you are taking this medicine. To prevent the loss of too much water and potassium, tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea. Check with your doctor right away if you have one or more of these symptoms: dry mouth; increased thirst; muscle cramps; or nausea or vomiting .

This medicine may cause changes in your blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor .

Side Effects of This Medicine:

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:

Rare

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

Incidence not determined

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:

Symptoms of overdose

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:

Incidence not determined

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.