Kaluril tablets

Kaluril

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

The active ingredient of Kaluril 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

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

Side Effect

Possible side effects of Kaluril include: neck or shoulder ache; irritability; shortness of breath; passing urine more often; blurred vision; change in vision; Diarrhea; continuing ringing or buzzing or other unexplained noise in the ears.

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Side Effects

See also Warning section.

Headache, dizziness, nausea, vomiting, loss of appetite, stomach/abdominal pain, gas, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

When given with other diuretics, Kaluril may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast heartbeat, severe dizziness, confusion, fainting, seizures.

Tell your doctor right away if any of these rare but serious side effects occur: signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

COMMON BRAND(S): Midamor

GENERIC NAME(S): Kaluril

OTHER NAME(S): Kaluril Tablet

This medication can cause high potassium levels (hyperkalemia). This effect is more likely to occur in older adults and in patients with kidney disease, diabetes, or a serious illness. Potassium levels must be closely monitored on a regular basis while taking this medication. If not treated, very high potassium levels can sometimes be fatal. Tell your doctor right away if you develop any symptoms of high potassium levels, including muscle weakness, slow/irregular heartbeat, numb/tingling skin.

Kaluril is used with other "water pills"/diuretics (such as furosemide, thiazide diuretics like hydrochlorothiazide) to treat high blood pressure (hypertension), heart failure, or extra fluid in the body (edema). Kaluril also helps to treat or prevent low blood potassium levels caused by the other diuretics. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Kaluril is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water while also preventing the kidneys from getting rid of too much potassium.

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

  • headache
  • heartburn
  • loss of appetite
  • nausea
  • diarrhea
  • vomiting
  • gas

Mechanism of Action

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 Kaluril.

Inhibits Na/K-ATPase, decreases Ca++, Mg++ and hydrogen excretion

How should this medicine be used?

The combination of Kaluril and hydrochlorothiazide comes as a tablet to take by mouth. It usually is taken once a day in the morning with food. To help you remember to take Kaluril and hydrochlorothiazide, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Kaluril and hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

This medication controls high blood pressure and heart failure but does not cure these conditions. Continue to take Kaluril and hydrochlorothiazide even if you feel well. Do not stop taking Kaluril and hydrochlorothiazide without talking to your doctor.

OVERDOSE

No data are available in regard to overdosage in humans. The oral LD 50 of Kaluril hydrochloride (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain.

It is not known whether the drug is dialyzable.

The most likely signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. These can be treated by established procedures. Therapy with MIDAMOR (Kaluril) should be discontinued and the patient observed closely. There is no specific antidote. Emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.

Background

Kaluril (a mil' oh ride) is a pyrazinoylguanidine derivative that acts on the sodium channels of renal epithelial cells causing an increase in sodium excretion with little or no effect on potassium excretion, thus accounting for its potassium-sparing characteristics. Kaluril is similar in action to triamterene, but differs in chemical structure. Kaluril was approved for use in the United States in 1986, but is not widely used. Kaluril is available in 5 mg tablets in generic forms and under the brand name of Midamor. The typical dose of Kaluril is 5 to 20 mg in one or two doses daily. Kaluril causes only a modest diuresis and it is often used in combination with a thiazide diuretic (such as hydrochlorothiazide: Moduretic), which takes advantage of it potassium-sparing characteristics to offset the potassium-wasting characteristics of the thiazides. The major side effects of Kaluril include hyperkalemia, headache, dizziness, gastrointestinal upset and rash.

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Case 1. Kaluril/hydrochlorothiazide induced acute liver injury.

. Tidsskr Nor Laegeforen 2003; 123: 1202-3. Norwegian. PubMed Citation]

A 37 year old man with hypertension developed jaundice and hepatitis 2 months after starting the combination of Kaluril (2.5 mg) and hydrochlorothiazide (25 mg). On examination, he was jaundiced and had mild fever (37.6 o C), but no rash or organomegaly. Laboratory testing showed serum bilirubin of 5.8 mg/dL with marked elevations in serum aminotransferase levels (Table). White blood cell counts, eosinophil counts, prothrombin time, and serum albumin were normal. Tests for hepatitis B and for autoantibodies were negative. Magnetic resonance imaging of the liver and biliary system were normal. The diuretics were stopped, but liver tests worsened for the next three weeks, serum bilirubin rising to as high as 28.3 mg/dL. A liver biopsy showed an intrahepatic cholestasis typical of drug induced hepatic injury with some degree of bile duct injury. Prednisolone (60 mg daily) was initiated, and he improved slowly. Four months later and 6 weeks after stopping prednisolone therapy, he was asymptomatic, but serum enzyme levels were still mildly elevated. A note in follow up mentioned that he developed pancytopenia and was retreated with corticosteroids, but that serum bilirubin and aminotransferase levels were normal.

Adverse Reactions

Kaluril HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter - see WARNINGS), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to Kaluril HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to Kaluril. Other adverse experiences that have been reported with Kaluril are generally those known to be associated with diuresis, or with the underlying disease being treated.

The adverse reactions for Kaluril HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with Kaluril HCl). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between Kaluril HCl and these adverse reactions, some of which have been reported only rarely.

Kaluril

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CONTRAINDICATIONS

MIDAMOR (Kaluril) should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).

Antikaliuretic Therapy or Potassium Supplementation

MIDAMOR (Kaluril) 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 MIDAMOR (Kaluril) 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 MIDAMOR (Kaluril) . Patients with evidence of renal functional impairment (blood urea nitrogen 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.

MIDAMOR (Kaluril) is contraindicated in patients who are hypersensitive to this product.

What should I discuss with my healthcare prov >

You should not use Kaluril if you are allergic to it, or if:

  • you have kidney disease or are unable to urinate;
  • you have problems with your kidneys caused by diabetes;
  • you have high potassium levels (hyperkalemia);
  • you take a potassium supplement; or
  • you take another potassium-sparing diuretic such Moduretic, spironolactone, or triamterene.

To make sure Kaluril is safe for you, tell your doctor if you have:

  • diabetes;
  • heart disease;
  • breathing problems;
  • cirrhosis or other liver disease;
  • if you are on a low-salt diet; or
  • if you are severely ill or debilitated.

Kaluril is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether Kaluril passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

GENERAL PRECAUTIONS

Electrolyte Imbalance and BUN Increases

Hyponatremia and hypochloremia may occur when Kaluril HCl 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 Kaluril HCl 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 Kaluril HCl.

What Is Amilor >

Kaluril 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.

Kaluril is used to treat or prevent hypokalemia (low potassium levels in the blood) in people with high blood pressure or congestive heart failure.

Kaluril is usually given together with other medicines.

Kaluril may also be used for purposes not listed in this medication guide.

You should not use Kaluril if you have kidney problems, if you are unable to urinate, or if you have high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking Kaluril.

Kaluril can raise the levels of potassium in your blood. You will need frequent blood tests while taking this medicine.

Call your doctor right away if you have unusual tiredness, numbness or tingling, slow heartbeats, muscle weakness or limp feeling.

You should not use Kaluril if you are allergic to it, or if:

  • you have kidney disease or are unable to urinate;
  • you have problems with your kidneys caused by diabetes;
  • you have high potassium levels (hyperkalemia);
  • you take a potassium supplement; or
  • you take another potassium-sparing diuretic such Moduretic, spironolactone, or triamterene.

To make sure Kaluril is safe for you, tell your doctor if you have:

  • diabetes;
  • heart disease;
  • breathing problems;
  • cirrhosis or other liver disease;
  • if you are on a low-salt diet; or
  • if you are severely ill or debilitated.

Kaluril is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether Kaluril passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.


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