A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Aldactone Side Effects, and Drug Interactions - Spironolactone
Aldactone Side Effects, and Drug Interactions - Spironolactone
SIDE EFFECTS
The following adverse reactions have been reported and
within each category (body system), are listed in order
of decreasing severity.
Digestive: Gastric bleeding,
ulceration, gastritis,
diarrhea and cramping, nausea,
vomiting.
Endocrine: Gynecomastia (see PRECAUTIONS),
inability to achieve or maintain erection,
irregular menses or amenorrhea,
postmenopausal bleeding. Carcinoma of the breast
has been reported in patients taking spironolactone
but a cause and effect
relationship has not been established.
Hematologic: Agranulocytosis.
Hypersensitivity: Fever, urticaria,
maculopapular
or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Nervous system/psychiatric: Mental confusion,
ataxia, headache, drowsiness,
lethargy.
Liver/biliary: A very few cases of mixed
cholestatic/hepatocellular toxicity, with one reported fatality,
have been reported with spironolactone administration.
Renal: Renal dysfunction (including renal failure).
DRUG INTERACTIONS
ACE inhibitors: Concomitant administration
of ACE inhibitors with potassium-sparing
diuretics has been associated with severe hyperkalemia.
Alcohol, barbiturates, or narcotics: Potentiation
of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte
depletion, particularly hypokalemia,
may occur.
Pressor amines (eg, norepinephrine): Spironolactone
reduces the vascular
responsiveness to norepinephrine. Therefore, caution should be exercised
in the management of patients subjected to regional or general anesthesia
while they are being treated with Aldactone.
Skeletal muscle
relaxants, nondepolarizing (eg, tubocurarine): Possible
increased responsiveness to the muscle
relaxant may result.
Lithium: Lithium generally should not be given with
diuretics. Diuretic agents reduce
the renal clearance
of lithium and add
a high risk of lithium
toxicity.
Nonsteroidal anti-inflammatory
drugs (NSAIDs): In some patients, the administration
of an NSAID can reduce
the diuretic, natriuretic,
and antihypertensive
effect of loop, potassium-sparing
and thiazide diuretics. Combination of NSAIDs, eg, indomethacin,
with potassium-sparing diuretics has been associated with severe
hyperkalemia. Therefore, when Aldactone and NSAIDs
are used concomitantly, the patient
should be observed closely to determine if the desired effect
of the diuretic is
obtained.
Digoxin: Spironolactone has been shown to increase
the half-life of digoxin. This may result in increased serum
digoxin levels and subsequent
digitalis toxicity.
It may be necessary to reduce
the maintenance and digitalization
doses when spironolactone
is administered, and the patient should be carefully monitored to
avoid over- or underdigitalization.
Drug/Laboratory Test
Interactions
Several reports of possible interference with digoxin
radioimmunoassays by spironolactone, or its metabolites, have appeared
in the literature. Neither the extent nor the potential
clinical significance of its interference
(which may be assay-specific) has been fully established.
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