Co-Amilozide tablets

Co-Amilozide

  • Active Ingredient: Amiloride
  • 45 mg
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What is Co-Amilozide?

The active ingredient of Co-Amilozide 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

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

Side Effect

Possible side effects of Co-Amilozide include: sleeplessness; cough; lower back or side pain; loss in sexual ability, desire, drive, or performance; double vision; Abdominal pain.

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SIDE EFFECTS

MIDAMOR (Co-Amilozide) is usually well tolerated and except for hyperkalemia (serum potassium levels greater than 5.5 mEq per liter † see BOXED WARNING), 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 Co-Amilozide 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 Co-Amilozide. Other adverse experiences that have been reported with Co-Amilozide are generally those known to be associated with diuresis, or with the underlying disease being treated.

The adverse reactions for MIDAMOR (Co-Amilozide) 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 MIDAMOR (Co-Amilozide) ). 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 MIDAMOR (Co-Amilozide) and these adverse reactions, some of which have been reported only rarely.

** Reactions occurring in 3% to 8% of patients treated with MIDAMOR (Co-Amilozide) . (Those reactions occurring in less than 3% of the patients are unmarked.) *** See BOXED WARNING.

Causal Relationship Unknown: Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

Background

Co-Amilozide (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. Co-Amilozide is similar in action to triamterene, but differs in chemical structure. Co-Amilozide was approved for use in the United States in 1986, but is not widely used. Co-Amilozide is available in 5 mg tablets in generic forms and under the brand name of Midamor. The typical dose of Co-Amilozide is 5 to 20 mg in one or two doses daily. Co-Amilozide 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 Co-Amilozide include hyperkalemia, headache, dizziness, gastrointestinal upset and rash.

Amilor >Co-Amilozide 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, Co-Amilozide has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone. Co-Amilozide has potassium-conserving activity in patients receiving kaliureticdiuretic agents.

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

Co-Amilozide 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 Co-Amilozide.

Co-Amilozide 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 Co-Amilozide HCl up to approximately 15 mg.

Co-Amilozide HCl is not metabolized by the liver but is excreted unchanged by the kidneys. About 50 percent of a 20 mg dose of Co-Amilozide HCl is excreted in the urine and 40 percent in the stool within 72 hours. Co-Amilozide has little effect on glomerular filtration rate or renal blood flow. Because Co-Amilozide 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.

Nursing Mothers

Studies in rats have shown that Co-Amilozide is excreted in milk in concentrations higher than those found in blood, but it is not known whether Co-Amilozide 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 Co-Amilozide HCl, 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.

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, Co-Amilozide 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.

Co-Amilozide 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

Before taking Co-Amilozide,

  • tell your doctor and pharmacist if you are allergic to Co-Amilozide, any other medications, or any of the ingredients in Co-Amilozide. 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 Co-Amilozide 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 Co-Amilozide.
  • 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 Co-Amilozide, call your doctor immediately.

Before taking Co-Amilozide and hydrochlorothiazide,

  • tell your doctor and pharmacist if you are allergic to Co-Amilozide, hydrochlorothiazide, sulfonamide containing medications, any other medications, or any of the ingredients in Co-Amilozide and hydrochlorothiazide tablets. Ask your pharmacist or check the patient information for a list of the ingredients.
  • do not take Co-Amilozide and hydrochlorothiazide if you are taking spironolactone (Aldactone, in Aldactazide), other medications containing triamterene, or potassium supplements or potassium-containing medication supplements.
  • 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); barbiturates such as phenobarbital and secobarbital (Seconal); corticosteroids such as betamethasone (Celestone), budesonide (Entocort), cortisone (Cortone), dexamethasone (Decadron, others), fludrocortisone (Floriner), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, others), prednisone (Rayos), and triamcinolone (Aristocort, Azmacort); corticotropin (ACTH H.P., Acthar Gel); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); insulin and oral medications for diabetes; lithium (Lithobid); medications for high blood pressure; 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.
  • if you are taking cholestyramine or colestipol, take them 1 hour before or 4 hours after taking Co-Amilozide and hydrochlorothiazide.
  • tell your doctor if you have kidney disease. Your doctor may tell you not to take Co-Amilozide and hydrochlorothiazide.
  • tell your doctor if you have or have ever had diabetes, gout, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Co-Amilozide and hydrochlorothiazide, call your doctor immediately.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Co-Amilozide and hydrochlorothiazide.
  • you should know that Co-Amilozide and hydrochlorothiazide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking Co-Amilozide and hydrochlorothiazide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Alcohol can add to these side effects.

Mechanism of Injury

The mechanism of Co-Amilozide hepatic injury is unknown, but is likely due to metabolic idiosyncrasy.

Case 1. Co-Amilozide/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 Co-Amilozide (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.

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 Co-Amilozide 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.

OVERDOSE

No data are available in regard to overdosage in humans. The oral LD 50 of Co-Amilozide 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 (Co-Amilozide) 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.

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 Co-Amilozide. Your doctor may order certain lab tests to check your body's response to Co-Amilozide.

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.

What should I avo >

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking Co-Amilozide.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Drinking alcohol with this medicine can cause side effects.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.


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