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
Univasc Side Effects, and Drug Interactions - Moexipril
Univasc Side Effects, and Drug Interactions - Moexipril
SIDE EFFECTS
UNIVASC® has been evaluated for safety in more than
2500 patients with hypertension; more than 250 of these patients
were treated for approximately one year. The overall incidence
of reported adverse events was only slightly greater in patients
treated with UNIVASC® than patients treated with
placebo.
Reported adverse experiences were usually mild and transient, and
there were no differences
in adverse reaction
rates related to gender,
race, age, duration
of therapy, or total
daily dosage within the
range of 3.75 mg to 60
mg. Discontinuation of therapy
because of adverse experiences was required in 3.4% of patients
treated with UNIVASC® and in 1.8% of patients treated
with placebo. The most common reasons for discontinuation in patients
treated with UNIVASC® were cough
(0.7%) and dizziness (0.4%).
All adverse experiences considered at least possibly related to
treatment that occurred at any dose
in placebo-controlled trials of once-daily dosing in more than 1%
of patients treated with UNIVASC® alone and that
were at least as frequent in the UNIVASC® group as
in the placebo group
are shown in the following table:
|
Adverse Events in Placebo-Controlled Studies
|
| |
UNIVASC®
(N=674)
|
Placebo
(N=226)
|
|
Adverse Event
|
N
|
(%)
|
N
|
(%)
|
| Cough Increased |
41
|
(6.1)
|
5
|
(2.2)
|
| Dizziness |
29
|
(4.3)
|
5
|
(2.2)
|
| Diarrhea |
21
|
(3.1)
|
5
|
(2.2)
|
| Flu Syndrome |
21
|
(3.1)
|
0
|
(0)
|
| Fatigue |
16
|
(2.4)
|
4
|
(1.8)
|
| Pharyngitis |
12
|
(1.8)
|
2
|
(0.9)
|
| Flushing |
11
|
(1.6)
|
0
|
(0)
|
| Rash |
11
|
(1.6)
|
2
|
(0.9)
|
| Myalgia |
9
|
(1.3)
|
0
|
(0)
|
Other adverse events occurring in more than 1% of patients
on moexipril that were at least as frequent on placebo
include: headache, upper respiratory
infection, pain,
rhinitis, dyspepsia,
nausea, peripheral edema,
sinusitis, chest
pain, and urinary
frequency. See WARNINGS and
PRECAUTIONS for discussion
of anaphylactoid reactions, angioedema,
hypotension, neutropenia/agranulocytosis,
second and third trimester
fetal/neonatal morbidity
and mortality, hyperkalemia,
and cough. Other potentially important adverse experiences reported
in controlled or uncontrolled clinical
trials in less than 1% of moexipril patients or that have been attributed
to other ACE inhibitors
include the following:
Cardiovascular: Symptomatic hypotension,
postural hypotension,
or syncope were seen
in 9/1750 (0.51%) patients; these reactions led to discontinuation
of therapy in controlled
trials in 3/1254 (0.24%) patients who had received UNIVASC®
monotherapy and
in 1/344 (0.3%) patients who had received UNIVASC®
with hydrochlorothiazide (see PRECAUTIONS
and WARNINGS). Other adverse
events included angina/myocardial infarction, palpitations, rhythm
disturbances, and cerebrovascular
accident.
Renal: Of hypertensive
patients with no apparent
preexisting renal disease,
1% of patients receiving UNIVASC® alone and 2% of
patients receiving UNIVASC® with hydrochlorothiazide
experienced increases in serum
creatinine to at
least 140% of their baseline values (see PRECAUTIONS
and DOSAGE AND ADMINISTRATION).
Gastrointestinal: Abdominal pain,
constipation, vomiting,
appetite/weight change, dry mouth,
pancreatitis, hepatitis.
Respiratory: Bronchospasm, dyspnea.
Urogenital: Renal insufficiency, oliguria.
Dermatologic: Apparent hypersensitivity
reactions manifested by urticaria,
rash, pemphigus,
pruritus, photosensitivity.
Neurological and Psychiatric: Drowsiness, sleep
disturbances, nervousness, mood
changes, anxiety.
Other: Angioedema (see WARNINGS),
taste disturbances, tinnitus,
sweating, malaise, arthralgia,
hemolytic anemia.
Clinical Laboratory Test Findings
Creatinine and Blood Urea Nitrogen: As with other
ACE inhibitors, minor increases
in blood urea
nitrogen or serum
creatinine, reversible
upon discontinuation of therapy,
were observed in approximately 1% of patients with essential
hypertension who
were treated with UNIVASC®. Increases are more likely
to occur in patients receiving concomitant
diuretics and in patients with compromised renal
function (see PRECAUTIONS,
General).
Other (causal relationship unknown): Clinically important
changes in standard
laboratory tests
were rarely associated with UNIVASC® administration.
Elevations of liver enzymes
and uric acid
have been reported. In trials,
less than 1% of moexipril-treated patients discontinued UNIVASC®
treatment because of laboratory
abnormalities. The incidence
of abnormal laboratory values with moexipril was similar to that
in the placebo-treated group.
DRUG INTERACTIONS
Diuretics: Excessive reductions in blood
pressure may occur
in patients on diuretic
therapy when ACE
inhibitors are started. The possibility of hypotensive
effects with UNIVASC® can be minimized by discontinuing
diuretic therapy
for several days or cautiously increasing salt
intake before initiation
of treatment with
UNIVASC®. If this is not possible, the starting dose
of moexpril should be reduced. (see WARNINGS
and DOSAGE AND ADMINISTRATION).
Potassium Supplements and Potassium-Sparing Diuretics:
UNIVASC® can increase serum
potassium because
it decreases aldosterone secretion. Use of potassium-sparing diuretics
(spironolactone, triamterene, amiloride) or potassium
supplements concomitantly with ACE inhibitors can increase the risk
of hyperkalemia. Therefore, if concomitant use of such
agents is indicated, they should be given with caution and the patient's
serum potassium
should be monitored.
Oral Anticoagulants: Interaction studies with warfarin
failed to identify any clinically important effect
on the serum concentrations
of the anticoagulant
or on its anticoagulant
effect.
Lithium: Increased serum
lithium levels and symptoms
of lithium toxicity
have been reported in patients receiving ACE
inhibitors during therapy
with lithium. These drugs should be coadministered with caution,
and frequent monitoring of serum
lithium levels is recommended.
If a diuretic is also
used, the risk of lithium
toxicity may be increased.
Other Agents: No clinically important pharmacokinetic
interactions occurred when UNIVASC® was administered
concomitantly with hydrochlorothiazide, digoxin, or cimetidine.
UNIVASC® has been used in clinical
trials concomitantly with calcium-channel-blocking agents, diuretics,
H2 blockers, digoxin, oral
hypoglycemic agents, and cholesterol-lowering agents. There was
no evidence
of clinically important adverse interactions.
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