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
Moduretic Side Effects, and Drug Interactions - Amiloride and Hydrochlorothiazide
Moduretic Side Effects, and Drug Interactions - Amiloride and Hydrochlorothiazide
SIDE EFFECTS
MODURETIC 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 MODURETIC is about
1-2 percent in patients without
renal impairment
or diabetes mellitus (see
WARNINGS). Minor adverse reactions
to amiloride HCl 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 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 MODURETIC are generally those
known to be associated with diuresis,
thiazide therapy, or with
the underlying disease being treated. Clinical trials have not demonstrated
that combining amiloride and hydrochlorothiazide
increases the risk of adverse
reactions over those seen with the individual components.
The adverse reactions for MODURETIC 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 (607 patients treated with MODURETIC). 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 MODURETIC and these adverse reactions,
some of which have been reported only rarely.
|
Incidence > 1 %
|
Incidence < 1%
|
|
Body as a Whole
|
| Headache**
Weakness**
Fatigue/ tiredness
|
Malaise
Chest pain
Back pain
Syncope
|
|
Cardiovascular
|
| Arrhythmia |
Tachycardia
Digitalis toxicity
Orthostatic hypotension
Angina pectoris
|
|
Digestive
|
| Nausea/ anorexia**
Diarrhea
Gastrointestinal pain
Abdominal pain
|
Constipation
GI bleeding
GI disturbance
Appetite changes
Abdominal fullness
Hiccups
Thirst
Vomiting
Anorexia
Flatulence
|
|
Metabolic
|
| Elevated serum
potassium levels (> 5.5 mEq
per liter)*** |
Gout
Dehydration
Symptomatic hyponatremiat
|
|
Musculoskeletal
|
| Leg ache
|
Muscle cramps/ spasm
Joint pain
|
|
Nervous
|
| Dizziness |
Paresthesia/ numbness
Stupor
Vertigo
|
|
Psychiatric
|
| None |
Insomnia
Nervousness
Depression
Sleepiness
Mental confusion
|
|
Respiratory
|
| Dyspnea |
None |
|
Skin
|
| Rash**
Pruritus
|
Flushing
Diaphoresis
Erythema multiforme including
Stevens- Johnson syndrome
Exfoliative dermatitis
including
toxic epidermal necrolysis
Alopecia
|
|
Special Senses
|
| None |
Bad taste
Visual disturbance
Nasal congestion
|
|
Urogenital
|
| None |
Impotence
Nocturia
Dysuria
Incontinence
Renal dysfunction
including
renal failure
Gynecomastia
|
| ** Reactions occurring in
3% to 8% of patients treated with MODURETIC. (Those reactions occurring
in less than 3% of the patients are unmarked.) |
| *** See WARNINGS.
|
Other adverse reactions that have been reported with the individual
components and within each category are listed in order
of decreasing severity:
Amiloride
Body as a Whole: Painful extremities, neck/ shoulder
ache, fatigability;
Cardiovascular: Palpitation;
Digestive: Activation of probable pre- existing peptic
ulcer, abnormal liver
function, jaundice, dyspepsia,
heartburn;
Hematologic: Aplastic anemia,
neutropenia;
Integumentary: Alopecia, itching, dry mouth;
Nervous System/ Psychiatric: Encephalopathy, tremors, decreased
libido;
Respiratory: Shortness of breath, cough;
Special Senses: Increased intraocular
pressure, tinnitus;
Urogenital: Bladder spasms, polyuria,
urinary frequency.
Hydrochlorothiazide
Digestive: Pancreatitis, jaundice
(intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric
irritation;
Hematologic: Aplastic anemia,
agranulocytosis, leukopenia,
hemolytic anemia, thrombocytopenia;
Hypersensitivity: Anaphylactic reactions, necrotizing anglitis
(vasculitis, cutaneous vasculitis),
respiratory distress
including pneumonitis and pulmonary
edema, photosensitivity,
fever, urticaria,
purpura;
Metabolic: Electrolyte imbalance
(see PRECAUTIONS), hyperglycemia,
glycosuria, hyperuricemia;
Nervous System/ Psychiatric: Restlessness;
Special Senses: Transient blurred vision, xanthopsia;
Urogenital: Interstitial nephritis
(see WARNINGS).
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 MODURETIC 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 MODURETIC, 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.
Amiloride HCl
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.)
Hydrochlorothiazide
When given concurrently the following drugs may interact with thiazide
diuretics.
Alcohol, barbiturates, or narcotics: potentiation
of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and insulin): dosage
adjustment of the antidiabetic
drug may be required.
Other antihypertensive
drugs: additive effect
or potentiation.
Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide
is impaired in the presence of anionic exchange
resins. Single doses of either cholestyramine or colestipol resins bind
the hydrochlorothiazide and reduce
its absorption from the
gastrointestinal
tract by up to 85 and 43 percent,
respectively.
Corticosteroids, ACTH: intensified electrolyte
depletion, particularly hypokalemia.
Pressor amines (e.g., norepinephrine): possible decreased
response to pressor amines
but not sufficient to preclude their use.
Skeletal muscle relaxants,
nondepolarizing (e.g., tubocurarine): possible increased responsiveness
to the muscle relaxant.
Lithium: generally should not be given with diuretics.
Diuretic agents reduce the
renal clearance
of lithium and add
a high risk of lithium toxicity.
Refer to the package insert for lithium
preparations before use of such preparations with MODURETIC.
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