Ethacrynic acid (oral route)


    Brand Name

    US Brand Name

    Edecrin


    Description

    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 .

    This product is available in the following dosage forms:

    • Tablet

    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 ethacrynic acid in children below 2 years of age. 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 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 .

    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

    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
    • Benzhydrocodone
    • Bepridil
    • Bromfenac
    • Bufexamac
    • Buprenorphine
    • Cefepime
    • Celecoxib
    • Choline Salicylate
    • Clonixin
    • Codeine
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Digitoxin
    • Dihydrocodeine
    • Dipyrone
    • Dofetilide
    • Droperidol
    • Droxicam
    • Epinephrine
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Felbinac
    • Fenoprofen
    • Fentanyl
    • Fepradinol
    • Feprazone
    • Floctafenine
    • Flufenamic Acid
    • Flurbiprofen

    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

    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

    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

    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.






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