Ethacrynate sodium (Intravenous)

Ethacrynate sodium injection is part of a group of medicines known as loop diuretics or "water pills." Ethacrynate sodium is used to help treat fluid retention (edema) and swelling caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by affecting the kidneys to increase urine flow.

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

Your doctor will only give you a few doses of this medicine until your condition improves, and then you will be switched to another medicine that works the same way. If you have any concerns about this, talk to your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ethacrynate sodium injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies done so far have not shown any problems specific to older adults that would limit the usefulness of ethacrynate sodium injection in this age group. However, older patients are more likely to have kidney problems related to aging, which may require a dosage adjustment for those receiving ethacrynate sodium injection.

Breast Feeding

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

Interactions with Medicines

Although some medicines should not be used together, there are cases where two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are selected based on 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 necessary 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
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sotalol
• Streptomycin
• Sulindac
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may increase the 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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having 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 worsen these conditions.

• 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 the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 the 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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
• irritation, or pain at injection site
• 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.

In the U.S.

• Edecrin Sodium

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Ethacrynic Acid

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.