Amiloride Hydrochloride And Hydrochlorothiazide
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Questions & Answers
Side Effects & Adverse Reactions
Hyperkalemia
Like other potassium-conserving diuretic combinations, amiloride and hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1 to 2 percent. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy). Since hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving amiloride hydrochloride and hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.
The risk of hyperkalemia may be increased when potassium-conserving agents, including amiloride hydrochloride and hydrochlorothiazide, are administered concomitantly with an angiotensin-converting enzyme inhibitor, cyclosporine or tacrolimus. (See PRECAUTIONS: Drug Interactions.) Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the serum potassium level is essential because mild hyperkalemia is not usually associated with an abnormal ECG.
When abnormal, the ECG in hyperkalemia is characterized primarily by tall, peaked T waves or elevations from previous tracings. There may also be lowering of the R wave and increased depth of the S wave, widening and even disappearance of the P wave, progressive widening of the QRS complex, prolongation of the PR interval, and ST depression.
Treatment of HyperkalemiaIf hyperkalemia occurs in patients taking amiloride and hydrochlorothiazide, the drug should be discontinued immediately. If the serum potassium level exceeds 6.5 mEq per liter, active measures should be taken to reduce it. Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. Patients with persistent hyperkalemia may require dialysis.
Diabetes MellitusIn diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including amiloride HCl, even in patients without evidence of diabetic nephropathy. Therefore, amiloride and hydrochlorothiazide should be avoided, if possible, in diabetic patients and, if it is used, serum electrolytes and renal function must be monitored frequently.
Amiloride and hydrochlorothiazide should be discontinued at least three days before glucose tolerance testing.
Metabolic or Respiratory AcidosisAntikaliuretic therapy should be instituted only with caution in severely ill patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or poorly controlled diabetes. If amiloride and hydrochlorothiazide is given to these patients, frequent monitoring of acid-base balance is necessary. Shifts in acid-base balance alter the ratio of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in serum potassium levels.
Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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 hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects.
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
History
There is currently no drug history available for this drug.
Other Information
Amiloride hydrochloride and hydrochlorothiazide tablets combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide.
Amiloride HCl is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene)pyrazinecarboxamide monohydrochloride, dihydrate. It has the following structural formula:
C6H8ClN7O•HCl•2H2O MW = 302.12
Hydrochlorothiazide is designated chemically as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It has the following structural formula:
C7H8ClN3O4S2 MW = 297.74
It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
Each tablet, for oral administration, contains 5 mg of amiloride hydrochloride (calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose (hydrous), magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and FD&C Yellow #6 Aluminum Lake.
Sources
Amiloride Hydrochloride And Hydrochlorothiazide Manufacturers
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Physicians Total Care, Inc.
![Amiloride Hydrochloride And Hydrochlorothiazide Tablet [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amiloride Hydrochloride And Hydrochlorothiazide | Physicians Total Care, Inc.
Amiloride HCl and hydrochlorothiazide tablets should be administered with food.
The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses. Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents.
The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.
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Barr Laboratories Inc.
Amiloride Hydrochloride And Hydrochlorothiazide | Barr Laboratories Inc.
Amiloride hydrochloride and hydrochlorothiazide tablets should be administered with food.
The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses.
Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents. The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.
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Mylan Pharmaceuticals Inc.
Amiloride Hydrochloride And Hydrochlorothiazide | Mylan Pharmaceuticals Inc.
Amiloride hydrochloride and hydrochlorothiazide tablets should be administered with food.
The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses. Hydrochlorothiazide can be given at doses of 12.5 mg to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents.
The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.
![Amiloride Hydrochloride And Hydrochlorothiazide Tablet [Barr Laboratories Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8b2c581a-f955-4a8e-bf85-e768e903fd10&name=4b7471b7-1883-45f2-b270-c5f7d5c9a302-03.jpg)
![Amiloride Hydrochloride And Hydrochlorothiazide Tablet [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc7aef5e-9585-45b9-b317-4af570202ef5&name=8d5cdb56-c6a1-449d-8d1a-469d83cafe9e-03.jpg)
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