Edecrin Sodium

Ethacrynate sodium 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 .

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ethacrynate sodium injection 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 ethacrynate sodium injection .

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Arsenic Trioxide


• Bepridil


• Digitoxin


• Dofetilide


• Droperidol


• Furosemide


• Ketanserin


• Levomethadyl


• Lithium


• Metolazone


• Sotalol

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.

• Aceclofenac


• Acemetacin


• Alacepril


• Alclofenac


• Apazone


• Benazepril


• Benoxaprofen


• Bromfenac


• Bufexamac


• Captopril


• Carprofen


• Celecoxib


• Cilazapril


• Clometacin


• Clonixin


• Cortisone


• Delapril


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fosinopril


• Gentamicin


• Germanium


• Ginseng


• Gossypol


• Ibuprofen


• Imidapril


• Indomethacin


• Indoprofen


• Isoxicam


• Kanamycin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentopril


• Perindopril


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Quinapril


• Ramipril


• Rofecoxib


• Spirapril


• Streptomycin


• Sulindac


• Suprofen


• Temocapril


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Trandolapril


• Valdecoxib


• Zofenopril


• Zomepirac

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, severea€”Should not use in patients with these conditions .

• Diabetesa€”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), advanceda€”Use with caution. This medicine may make these conditions worse .

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

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

Proper Use

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 .

Precautions

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 .

Side Effects

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 or nurse 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


• 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.