Ecodurex tablets

Ecodurex

  • Active Ingredient: Amiloride
  • 45 mg
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What is Ecodurex?

The active ingredient of Ecodurex brand is amiloride. Amiloride is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. Each tablet for oral administration contains 5 mg of Amiloride HCI, calculated on the anhydrous basis. Each tablet contains the following inactive ingredients: corn starch, crospovidone, lactose, magnesium stearate, microcrystalline cellulose and povidone. Amiloride HCl is not an aldosterone antagonist and its effects are seen even in the absence of aldosterone. Amiloride exerts its potassium sparing effect through the inhibition of sodium reabsorption at the distal convoluted tubule, cortical collecting tubule and collecting duct; this decreases the net negative potential of the tubular lumen and reduces both potassium and hydrogen secretion and their subsequent excretion. This mechanism accounts in large part for the potassium sparing action of Amiloride. Amiloride usually begins to act within 2 hours after an oral dose. Its effect on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about 24 hours. Peak plasma levels are obtained in 3 to 4 hours and the plasma half-life varies from 6 to 9 hours. Effects on electrolytes increase with single doses of Amiloride HCl up to approximately 15 mg. Amiloride HCl is not metabolized by the liver but is excreted unchanged by the kidneys. About 50 percent of a 20 mg dose of Amiloride HCl is excreted in the urine and 40 percent in the stool within 72 hours. Amiloride has little effect on glomerular filtration rate or renal blood flow. Because Amiloride HCl is not metabolized by the liver, drug accumulation is not anticipated in patients with hepatic dysfunction, but accumulation can occur if the hepatorenal syndrome develops. a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl tablets have little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride HCl tablets should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including Amiloride HCl tablets, result in an increased risk of hyperkalemia (approximately 10% with Amiloride). Amiloride HCl tablets should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes. Amiloride HCl tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Antikaliuretic Therapy or Potassium Supplementation Amiloride HCl tablets should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with Amiloride HCl tablets except in severe and/or refractory cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Impaired Renal Function Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of Amiloride HCl tablets. Patients with evidence of renal functional impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia. Hypersensitivity Amiloride HCl tablets are contraindicated in patients who are hypersensitive to this product. WARNINGS

Used for

Ecodurex is used to treat diseases such as: Ascites, Edema, Heart Failure, High Blood Pressure.

Side Effect

Possible side effects of Ecodurex include: wrinkled skin; fever; nervousness; trembling or shaking of the hands or feet; trouble concentrating.

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Before taking Ecodurex,

  • tell your doctor and pharmacist if you are allergic to Ecodurex, any other medications, or any of the ingredients in Ecodurex. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking spironolactone (Aldactone, in Aldactazide), other medications containing triamterene, or potassium supplements or potassium-containing medication supplements. Your doctor will probably tell you not to take Ecodurex if you are taking one or more of these medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin II receptor antagonists (ARB) such as azilsartan (Edarbi, Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, Benicar HCT), telmisartan (Micardis, in Micardis HCT), and valsartan (Diovan, in Diovan HCT, Exforge); cyclosporine (Gengraf, Neoral, Sandimmune); lithium (Lithobid); or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin), and naproxen (Aleve, Naprosyn, others); or tacrolimus (Astagraf XL, Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have kidney disease. Your doctor may tell you not to take Ecodurex.
  • tell your doctor if you have or have ever had diabetes or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Ecodurex, call your doctor immediately.

Why is this medication prescribed?

The combination of Ecodurex and hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure and heart failure in patients who have low amounts of potassium in their bodies or for whom low potassium levels in the body could be dangerous. Ecodurex and hydrochlorothiazide are in a class of medications called diuretics ('water pills'). They work by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Ecodurex and hydrochlorothiazide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • upset stomach
  • diarrhea
  • loss of appetite
  • stomach pain
  • gas
  • headache

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking Ecodurex and hydrochlorothiazide.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Precautions

See Also Warning section.

Before taking Ecodurex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent these effects and dehydration. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.

This drug may increase the potassium levels in your blood. Limit foods high in potassium such as bananas and orange juice. Consult your doctor or pharmacist before using any products containing potassium (such as potassium supplements, salt substitutes).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

How should I take Ecodurex?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Ecodurex with food.

Your doctor may recommend you eat certain foods or take supplements to keep your potassium from getting too low. Follow the diet and medication plan created for you by your doctor or nutrition counselor.

While using Ecodurex, you will need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Ecodurex. You may need to stop taking Ecodurex at least 3 days before having a glucose tolerance test.

Store at room temperature away from moisture, heat, or freezing temperatures.

Introduction

Ecodurex is a potassium-sparing diuretic used in the therapy of edema often in combination with thiazide diuretics. Ecodurex has been linked to rare cases of clinically apparent drug induced liver disease.

How to use Ecodurex-Hydrochlorothiazide

Take this medication by mouth with food, usually once or twice daily or as directed by your doctor.

If you take this drug too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. If you have any questions about how and when to take this medication, ask your doctor or pharmacist.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.

Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).

What other drugs will affect Ecodurex?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • lithium;
  • medicine to prevent organ transplant rejection --cyclosporine, tacrolimus;
  • an ACE inhibitor (angiotensin converting enzyme) --benazepril, captopril, enalapril, fosinipril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril;
  • heart or blood pressure medication --azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan; or
  • NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with Ecodurex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

PRECAUTIONS

Electrolyte Imbalance and BUN Increases: Hyponatremia and hypochloremia may occur when MIDAMOR (Ecodurex) is used with other diuretics and increases in BUN levels have been reported. These increases usually have accompanied vigorous fluid elimination, especially when diuretic therapy was used in seriously ill patients, such as those who had hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema. Therefore, when MIDAMOR (Ecodurex) is given with other diuretics to such patients, careful monitoring of serum electrolytes and BUN levels is important. In patients with pre-existing severe liver disease, hepatic encephalopathy, manifested by tremors, confusion, and coma, and increased jaundice, have been reported in association with diuretics, including Ecodurex HCl.

Carcinogenicity, Mutagenicity, Impairment of Fertility

There was no evidence of a tumorigenic effect when Ecodurex HCl was administered for 92 weeks to mice at doses up to 10 mg/kg/day (25 times the maximum daily human dose). Ecodurex HCl has also been administered for 104 weeks to male and female rats at doses up to 6 and 8 mg/kg/day (15 and 20 times the maximum daily dose for humans, respectively) and showed no evidence of carcinogenicity.

Ecodurex HCl was devoid of mutagenic activity in various strains of Salmonella typhimurium with or without a mammalian liver microsomal activation system (Ames test).

Pregnancy Category B: Teratogenicity studies with Ecodurex HCl in rabbits and mice given 20 and 25 times the maximum human dose, respectively, revealed no evidence of harm to the fetus, although studies showed that the drug crossed the placenta in modest amounts. Reproduction studies in rats at 20 times the expected maximum daily dose for humans showed no evidence of impaired fertility. At approximately 5 or more times the expected maximum daily dose for humans, some toxicity was seen in adult rats and rabbits and a decrease in rat pup growth and survival occurred.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Studies in rats have shown that Ecodurex is excreted in milk in concentrations higher than those found in blood, but it is not known whether MIDAMOR (Ecodurex) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from MIDAMOR (Ecodurex) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of (Midamor (Ecodurex) /Moduretic) did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CONTRAINDICATIONS, Impaired Renal Function.)

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to Ecodurex. Your doctor may order certain lab tests to check your body's response to Ecodurex.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Amilor >Ecodurex HCl is a potassium-conserving (antikaliuretic) drug that possesses weak (compared with thiazide diuretics) natriuretic, diuretic, and antihypertensive activity. These effects have been partially additive to the effects of thiazide diuretics in some clinical studies. When administered with a thiazide or loop diuretic, Ecodurex has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone. Ecodurex has potassium-conserving activity in patients receiving kaliureticdiuretic agents.

Ecodurex HCl is not an aldosterone antagonist and its effects are seen even in the absence of aldosterone.

Ecodurex exerts its potassium sparing effect through the inhibition of sodium reabsorption at the distal convoluted tubule, cortical collecting tubule and collecting duct; this decreases the net negative potential of the tubular lumen and reduces both potassium and hydrogen secretion and their subsequent excretion. This mechanism accounts in large part for the potassium sparing action of Ecodurex.

Ecodurex usually begins to act within 2 hours after an oral dose. Its effect on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about 24 hours. Peak plasma levels are obtained in 3 to 4 hours and the plasma half-life varies from 6 to 9 hours. Effects on electrolytes increase with single doses of Ecodurex HCl up to approximately 15 mg.

Ecodurex HCl is not metabolized by the liver but is excreted unchanged by the kidneys. About 50 percent of a 20 mg dose of Ecodurex HCl is excreted in the urine and 40 percent in the stool within 72 hours. Ecodurex has little effect on glomerular filtration rate or renal blood flow. Because Ecodurex HCl is not metabolized by the liver, drug accumulation is not anticipated in patients with hepatic dysfunction, but accumulation can occur if the hepatorenal syndrome develops.

What are the possible s >

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking Ecodurex and call your doctor at once if you have:

  • increased thirst, decreased urination;
  • heavy sweating, or hot and dry skin;
  • tremors, confusion, loss of consciousness;
  • jaundice (yellowing of the skin or eyes);
  • high potassium --tiredness, numbness or tingling, slow or unusual heart rate, muscle weakness or limp feeling; or
  • low levels of sodium in the body --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

  • nausea, stomach pain, gas, loss of appetite;
  • headache; or
  • rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Indications and Usage for Amilor >Ecodurex HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:

  • help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic.
  • prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Ecodurex HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.

Ecodurex HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including Ecodurex HCl, result in an increased risk of hyperkalemia (approximately 10% with Ecodurex). Ecodurex HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • dry mouth; thirst; numbness and tingling; confusion; muscle weakness, stomach pain, or cramps; fast heartbeat and other signs of dehydration and electrolyte imbalance
  • yellowing of the skin or eyes
  • chest pain
  • rash
  • itching
  • hives
  • difficulty breathing or swallowing

Ecodurex may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).


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