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
Midamor Side Effects, and Drug Interactions - Amiloride
Midamor Side Effects, and Drug Interactions - Amiloride
SIDE EFFECTS
MIDAMOR is usually well tolerated and except for hyperkalemia
(serum potassium levels greater than 5.5 mEq
per liter
— see BOXED WARNING), significant
adverse effects have been reported infrequently. Minor adverse reactions
were reported relatively frequently (about 20%) but the relationship of
many of the reports to amiloride HCl is uncertain and the overall frequency
was similar in hydrochlorothiazide
treated groups. Nausea/anorexia, abdominal
pain, flatulence,
and mild skin rash
have been reported and probably are related to amiloride. Other adverse
experiences that have been reported with amiloride are generally those
known to be associated with diuresis,
or with the underlying disease
being treated.
The adverse reactions for MIDAMOR listed in the following table
have been arranged into two groups: (1) incidence
greater than one percent; and (2) incidence
one percent or less. The incidence
for group (1) was determined
from clinical studies conducted
in the United States (837 patients treated with MIDAMOR). The adverse
effects listed in group (2)
include reports from the same clinical
studies and voluntary reports
since marketing. The probability
of a causal relationship exists between MIDAMOR and these adverse reactions,
some of which have been reported only rarely.
|
Incidence >1%
|
Incidence £
1%
|
| Body as a Whole |
Headache**
Weakness
Fatigability
|
Back pain
Chest pain
Neck/shoulder ache
Pain, extremities
|
| Cardiovascular |
None
|
Angina pectoris
Orthostatic hypotension
Arrhythmia
Palpitation
|
| Digestive |
Nausea/anorexia**
Diarrhea**
Vomiting**
Abdominal pain
Gas pain
Appetite changes
Constipation
|
Jaundice
GI bleeding
Abdominal fullness
GI disturbance
Thirst
Heartburn
Flatulence
Dyspepsia
|
| Metabolic |
Elevated serum
potassium levels
(> 5.5 mEq
per Liter)***
|
None
|
| Skin |
None
|
Skin rash
Itching
Dryness of mouth
Pruritus
Alopecia
|
| Musculoskeletal |
Muscle cramps
|
Joint pain
Leg ache
|
| Nervous |
Dizziness
Encephalopathy
|
Paresthesia
Tremors
Vertigo
|
| Psychiatric |
None
|
Nervousness
Mental confusion
Insomnia
Decreased libido
Depression
Somnolence
|
| Respiratory |
Cough
Dyspnea
|
Shortness of breath
|
| Special Senses |
None
|
Visual disturbances
Nasal congestion
Tinnitus
Increased intraocular
pressure
|
| Urogenital |
Impotence
|
Polyuria
Dysuria
Urinary frequency
Bladder spasms
Gynecomastia
|
** Reactions occurring in 3% to 8% of patients treated
with MIDAMOR. (Those reactions occurring in less than 3% of the patients
are unmarked.)
*** See BOXED WARNING.
Causal Relationship Unknown: Other reactions have been reported
but occurred under circumstances where a causal relationship could not
be established. However, in these rarely reported events, that possibility
cannot be excluded. Therefore, these observations are listed to serve
as alerting information to physicians.
- Activation of probable pre-existing peptic
ulcer
- Aplastic anemia
- Neutropenia
- Abnormal liver function
DRUG INTERACTIONS
When amiloride HCl is administered concomitantly with an angiotensin-converting
enzyme inhibitor, the risk
of hyperkalemia may be
increased. Therefore, if concomitant
use of these agents is indicated because of demonstrated hypokalemia,
they should be used with caution and with frequent monitoring of serum
potassium. (See WARNINGS.)
Lithium generally should not be given with diuretics because they reduce
its renal clearance
and add a high risk
of lithium toxicity. Read
circulars for lithium preparations
before use of such concomitant
therapy.
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 MIDAMOR and 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 MIDAMOR, 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.
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