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Amiloride/Hydrochlorothiazide

    DEA Class; Rx

    Common Brand Names; Moduretic

    • Thiazide Combos

    Oral combination product; potassium-sparing diuretic and thiazide diuretic; amiloride counteracts potassium loss due to HCTZ; useful in patients requiring thiazide diuretics with hypokalemia unresponsive to potassium supplements.

    Indicated for the treatment of hypertension, peripheral edema, or edema associated with heart failure in patients who develop hypokalemia when thiazides (or other kaliuretic diuretics) are used alone, or in patients with significant risks for hypokalemia (e.g., digitalized, cardiac arrhythmias).

    Hypersensitivity to amiloride, HCTZ or sulfonamides

    Concomitant use with potassium-sparing agents (eg, spironolactone, triamterene)

    Concomitant administration with any form of potassium supplementation

    Acute renal failure or evidence of diabetic nephropathy

    Anuria

    Hyperkalemia (potassium levels ≥ 5.5 mEq/L)

    Amiloride

    • Hyperkalemia (10%)

    • Impotence (<3%)

    • Diarrhea (3-8%)

    • Headache (3-8%)

    • Nausea (3-8%)

    • Vomiting (3-8%)

    • Abdominal pain (<3%)

    • Muscle cramps (<3%)

    • Appetite changes (<3%)

    • Constipation (<3%)

    • Cough (<3%)

    • Dizziness (<3%)

    • Dyspnea (<3%)

    • Encephalopathy (<3%)

    • Fatigue (<3%)

    • Weakness (<3%)

    • Gas pain (<3%)

    Hydrochlorothiazide

    • Anorexia

    • Epigastric distress

    • Hypotension

    • Orthostatic hypotension

    • Photosensitivity

    • Anaphylaxis

    • Anemia

    • Confusion

    • Erythema multiforme

    • Stevens-Johnson syndrome

    • Exfoliative dermatitis including toxic epidermal necrolysis

    • Dizziness

    • Hypokalemia and/or hypomagnesemia

    • Hyperuricemia

    • Headache

    Avoid use in patients with diabetes; may require adjustments in insulin or oral hypoglycemic treatment; hyperglycemia may occur during administration

    Electrolyte imbalance (hypokalemia, hypophosphatemia, hyperkalemia, hypercalcemia, hypomagnesemia, hyponatremia, or hypochloremic alkalosis) may occur

    Triglyceride and cholesterol levels may increase

    May experience increase in serum urea nitrogen (BUN), or serum creatinine

    Symptoms of lupus erythematosus may exacerbate

    Hydrochlorothiazide may cause acute transient myopia and acute angle closure glaucoma within hours or weeks of initiating therapy

    Gout symptoms may be precipitated

    Hypersensitivity reactions may occur with or without history of allergy or bronchial asthma

    Not for administration in patients with acute or chronic renal insufficiency (cumulative drug effects may be observed); diuretics may precipitate azotemia in renal disease

    Use caution in patients in whom respiratory or metabolic acidosis may occur

    Use caution in patients with hepatic impairment; minor alterations of fluid and electrolyte imbalance may precipitate hepatic coma

    The risk of hydrochlorothiazide toxicity may be greater in renal impairment

    Antihypertensive effects of this therapy may be enhanced in postsympathectomy patients

    Pregnancy Category: B

    Lactation: Excretion in breast milk is unknown. Because of the potential for serious adverse reactions in nursing infants, 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.

    Adults

    10 mg/day PO amiloride and 100 mg/day PO hydrochlorothiazide.

    Elderly

    10 mg/day PO amiloride and 100 mg/day PO hydrochlorothiazide.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Amiloride hydrochloride/hydrochlorothiazide

    tablet

    • 5mg/50mg