Amiloride Hydrochloride And Hydrochlorothiazide

Generic Name: amiloride hydrochloride and hydrochlorothiazide

Thiazide Diuretic [EPC]Over-the-Counter (OTC)

Brand Names:

Amiloride Hydrochloride And Hydrochlorothiazide

DESCRIPTION Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as N -amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is: C 6 H 8 CIN 7 O•HCl•2H 2 O M.W.

Overview

DESCRIPTION Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as N -amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is: C 6 H 8 CIN 7 O•HCl•2H 2 O M.W.

Uses

INDICATIONS AND USAGE 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.

Dosage

DOSAGE AND ADMINISTRATION 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.

Side Effects

ADVERSE REACTIONS Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS ). Minor adverse reactions to amiloride hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride.

Interactions

Drug Interactions In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when amiloride and hydrochlorothiazide plus non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including this product, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

Warnings

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). WARNINGS 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. CONTRAINDICATIONS Hyperkalemia Amiloride hydrochloride and hydrochlorothiazide tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).

Pregnancy

Pregnancy

Storage

HOW SUPPLIED Amiloride hydrochloride and hydrochlorothiazide tablets, USP are available as: 5 mg/50 mg: Light yellow, round, scored, biconvex tablet. Debossed with 555 over 483 on the scored side and stylized barr on the other side. Each tablet contains 5 mg of anhydrous amiloride HCl, USP and 50 mg of hydrochlorothiazide, USP.

Frequently Asked Questions

What is Amiloride Hydrochloride And Hydrochlorothiazide used for?

INDICATIONS AND USAGE 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.

What are the side effects of Amiloride Hydrochloride And Hydrochlorothiazide?

ADVERSE REACTIONS Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS ). Minor adverse reactions to amiloride hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride.

Can I take Amiloride Hydrochloride And Hydrochlorothiazide during pregnancy?

Pregnancy

What are the important warnings for Amiloride Hydrochloride And Hydrochlorothiazide?

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). WARNINGS 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. CONTRAINDICATIONS Hyperkalemia Amiloride hydrochloride and hydrochlorothiazide tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.