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|WARNING: Like other potassium-conserving agents, amiloride
may cause hyperkalemia
(serum potassium levels
greater than 5.5 mEq per liter)
which, if uncorrected, is potentially fatal: Hyperkalemia occurs commonly
(about 10%) when amiloride is used without a kaliuretic diuretic.
This incidence is greater
in patients with renal impairment,
diabetes mellitus (with
or without recognized renal
insufficiency), and in the elderly. When MIDAMOR is used concomitantly
with a thiazide diuretic
in patients without these complications, the risk
of hyperkalemia is
reduced to about 1-2 percent. It is thus essential
to monitor serum
potassium levels carefully
in any patient receiving
amiloride, particularly when it is first introduced, at the time
of diuretic dosage
adjustments, and during any illness
that could affect renal
Amiloride HCl, an antikaliuretic-diuretic agent,
is a pyrazine-carbonyl-guanidine that is unrelated chemically to other
known antikaliuretic or diuretic agents. It is the salt
of a moderately strong base (pKa
8.7). It is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene)
pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight
Its empirical formula
is C6H8ClN7O HCl 2H2O.
MIDAMOR (Amiloride HCl) is available for oral
use as tablets containing 5 mg
of anhydrous amiloride HCl.
Each tablet contains the following
inactive ingredients: calcium
phosphate, D&C Yellow 10, iron
oxide, lactose, magnesium stearate