Sodium Edecrin

Name: Sodium Edecrin

What do I need to tell my doctor BEFORE I take Sodium Edecrin?

For all patients taking Sodium Edecrin (ethacrynic acid injection):

  • If you have an allergy to ethacrynic acid or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are not able to pass urine.
  • If Sodium Edecrin caused very loose stools (diarrhea) before.
  • If you are breast-feeding or plan to breast-feed.

Children:

  • If your child is an infant. Do not give this medicine to an infant.

This is not a list of all drugs or health problems that interact with Sodium Edecrin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sodium Edecrin?

  • Tell all of your health care providers that you take Sodium Edecrin. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • This medicine is a strong fluid-lowering drug (diuretic). Sometimes too much water and major elements (potassium) in the blood may be lost. This can lead to serious health problems. Your doctor will follow you closely to change the dose to match your body's needs.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • You may need extra potassium. Talk with your doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Sodium Edecrin with your other drugs.
  • If you are taking this medicine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Watch for gout attacks.
  • If you are 65 or older, use Sodium Edecrin with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Very bad dizziness or passing out.
  • Ringing in ears.
  • Change in eyesight.
  • Fever or chills.
  • Very loose stools (diarrhea).
  • A burning, numbness, or tingling feeling that is not normal.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Black, tarry, or bloody stools.
  • Blood in the urine.
  • Feeling confused.
  • Hearing loss has rarely happened in people taking this medicine. This most often goes back to normal. The chance may be higher if you have kidney problems or if you take high doses of Sodium Edecrin (ethacrynic acid injection). Call your doctor right away if you have hearing problems like hearing loss.

Sodium Edecrin Description

Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is:

Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is:

EDECRIN is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous Sodium Edecrin (Ethacrynate Sodium) is a sterile freeze-dried powder and is supplied in a vial containing:

Ethacrynate sodium equivalent to ethacrynic acid...... 50.0 mg

Inactive ingredient:

Mannitol......................62.5 mg

Sodium Edecrin - Clinical Pharmacology

Pharmacokinetics and Metabolism

EDECRIN acts on the ascending limb of the loop of Henle and on the proximal and distal tubules. Urinary output is usually dose dependent and related to the magnitude of fluid accumulation. Water and electrolyte excretion may be increased several times over that observed with thiazide diuretics, since EDECRIN inhibits reabsorption of a much greater proportion of filtered sodium than most other diuretic agents. Therefore, EDECRIN is effective in many patients who have significant degrees of renal insufficiency (see WARNINGS concerning deafness). EDECRIN has little or no effect on glomerular filtration or on renal blood flow, except following pronounced reductions in plasma volume when associated with rapid diuresis.

The electrolyte excretion pattern of ethacrynic acid varies from that of the thiazides and mercurial diuretics. Initial sodium and chloride excretion is usually substantial and chloride loss exceeds that of sodium. With prolonged administration, chloride excretion declines, and potassium and hydrogen ion excretion may increase. EDECRIN is effective whether or not there is clinical acidosis or alkalosis.

Although EDECRIN, in carefully controlled studies in animals and experimental subjects, produces a more favorable sodium/potassium excretion ratio than the thiazides, in patients with increased diuresis excessive amounts of potassium may be excreted.

Onset of action is rapid, usually within 30 minutes after an oral dose of EDECRIN or within 5 minutes after an intravenous injection of Sodium Edecrin. After oral use, diuresis peaks in about 2 hours and lasts about 6 to 8 hours.

The sulfhydryl binding propensity of ethacrynic acid differs somewhat from that of the organomercurials. Its mode of action is not by carbonic anhydrase inhibition.

Ethacrynic acid does not cross the blood-brain barrier.

How is Sodium Edecrin Supplied

Tablets EDECRIN, 25 mg, are white, capsule shaped, scored tablets, coded VRX 205 on one side and EDECRIN on the other. They are supplied as follows:

NDC 25010-215-15
in bottles of 100.

Intravenous Sodium Edecrin is a dry white material either in a plug form or as a powder. It is supplied in vials containing ethacrynate sodium equivalent to 50 mg of ethacrynic acid,

NDC 25010-210-27.

Storage

Store in a tightly closed container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

EDECRIN®Tablets (ethacrynic acid)

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Steinbach, MB R5G1Z7, Canada

Made in Canada

Sodium Edecrin®Intravenous (ethacrynate sodium)

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Patheon Manufacturing Services LLC

Greenville, NC 27834 USA

© 2014 Valeant Pharmaceuticals International, Inc. or its affiliates

Rev. 12/14

9435700

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