SIDE EFFECTS
Benazepril HCl has been evaluated for safety in over
6000 patients with hypertension; over 700 of these patients
were treated for at least one year. The overall incidence
of reported adverse events was comparable in benazepril
HCl and placebo patients.
The reported side effects were generally mild and transient,
and there was no relation between side effects and age,
duration of therapy, or total dosage within the range
of 2 to 80 mg.
Discontinuation of therapy because of a side effect was
required in approximately 5% of U.S. patients treated
with benazepril HCl and in 3% of patients treated with
placebo.
The most common reasons for discontinuation were headache
(0.6%) and cough (0.5%) (see PRECAUTIONS, Cough).
The side effects considered possibly or probably related
to study drug that occurred in U.S. placebo-controlled
trials in more than 1% of patients treated with benazepril
HCl are shown in
SIDE EFFECTS
Benazepril HCl has been evaluated for safety in over
6000 patients with hypertension; over 700 of these patients
were treated for at least one year. The overall incidence
of reported adverse events was comparable in benazepril
HCl and placebo patients.
The reported side effects were generally mild and transient,
and there was no relation between side effects and age,
duration of therapy, or total dosage within the range
of 2 to 80 mg.
Discontinuation of therapy because of a side effect was
required in approximately 5% of U.S. patients treated
with benazepril HCl and in 3% of patients treated with
placebo.
The most common reasons for discontinuation were headache
(0.6%) and cough (0.5%) (see PRECAUTIONS, Cough).
The side effects considered possibly or probably related
to study drug that occurred in U.S. placebo-controlled
trials in more than 1% of patients treated with benazepril
HCl are shown in TABLE 1.
| TABLE 1
Patients In U.S. Placebo-Controlled Studies |
| |
Benazepril
HCl |
Placebo |
| |
(N = 964) |
(N = 496) |
| |
% |
N |
% |
N |
| Headache |
60 |
6.2 |
21 |
4.2 |
| Dizziness |
35 |
3.6 |
12 |
2.4 |
| Fatigue |
23 |
2.4 |
11 |
2.2 |
| Somnolence |
15 |
1.6 |
2 |
0.4 |
| Postural Dizziness |
14 |
1.5 |
1 |
0.2 |
| Nausea |
13 |
1.3 |
5 |
1.0 |
| Cough |
12 |
1.2 |
5 |
1.0 |
Other adverse experiences reported in controlled clinical
trials (in less than 1% of benazepril patients), and rarer
events seen in postmarketing experience, include the following
(in some, a causal relationship to drug use is uncertain):
Cardiovascular: Symptomatic hypotension
was seen in 0.3% of patients, postural hypotension in
0.4%, and syncope in 0.1%; these reactions led to discontinuation
of therapy in 4 patients who had received benazepril monotherapy
and in 9 patients who had received benazepril with hydrochlorothiazide
(see PRECAUTIONS and WARNINGS). Other reports included
angina pectoris, palpitations, and peripheral edema.
Renal: Of hypertensive patients with
no apparent preexisting renal disease, about 2% have sustained
increases in serum creatinine to at least 150% of their
baseline values while receiving benazepril HCl, but most
of these increases have disappeared despite continuing
treatment. A much smaller fraction of these patients (less
than 0.1%) developed simultaneous (usually transient)
increases in blood urea nitrogen and serum creatinine.
Fetal/Neonatal Morbidity and Mortality: See WARNINGS,
Fetal/Neonatal Morbidity and Mortality.
Angioedema: Angioedema has been reported
in patients receiving ACE inhibitors. During clinical
trials in hypertensive patients with benazepril, 0.5%
of patients experienced edema of the lips or face without
other manifestations of angioedema. Angioedema associated
with laryngeal edema and/or shock may be fatal. If angioedema
of the face, extremities, lips, tongue, or glottis and/or
larynx occurs, treatment with benazepril HCl should be
discontinued and appropriate therapy instituted immediately
(see WARNINGS).
Gastrointestinal: Constipation, gastritis,
vomiting, pancreatitis, and melena.
Dermatologic: Apparent hypersensitivity
reactions (manifested by dermatitis, pruritus, or rash),
photosensitivity, and flushing.
Neurologic and Psychiatric: Anxiety,
decreased libido, hypertonia, insomnia, nervousness, and
paresthesia.
Hematologic: There have been rare reports
of hemolytic anemia in patients receiving ACE inhibitors.
Other: Arthralgia, arthritis, asthenia,
asthma, bronchitis, dyspnea, impotence, infection, myalgia,
sinusitis, sweating, and urinary tract infection.
DRUG INTERACTIONS
Diuretics: Patients on diuretics, especially
those in whom diuretic therapy was recently instituted,
may occasionally experience an excessive reduction of
blood pressure after initiation of therapy with benazepril
HCl. The possibility of hypotensive effects with benazepril
HCl can be minimized by either discontinuing the diuretic
or increasing the salt intake prior to initiation of treatment
with benazepril HCl. If this is not possible, the starting
dose should be reduced (see DOSAGE AND ADMINISTRATION).
Potassium Supplements and Potassium-Sparing Diuretics
Benazepril HCl can attenuate potassium loss caused by
thiazide diuretics. Potassium-sparing diuretics (spironolactone,
amiloride, triamterene, and others) or potassium supplements
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 frequently.
Oral Anticoagulants
Interaction studies with warfarin and acenocoumarol failed
to identify any clinically important effects on the serum
concentrations or clinical effects of these anticoagulants.
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
No clinically important pharmacokinetic interactions
occurred when benazepril HCl was administered concomitantly
with hydrochlorothiazide, chlorthalidone, furosemide,
digoxin, propranolol, atenolol, naproxen, or cimetidine.
Benazepril HCl has been used concomitantly with beta-adrenergic-blocking
agents, calcium-channel-blocking agents, diuretics, digoxin,
and hydralazine, without evidence of clinically important
adverse interactions. Benazepril, like other ACE inhibitors,
has had less than additive effects with beta-adrenergic
blockers, presumably because both drugs lower blood pressure
by inhibiting parts of the renin-angiotensin system.
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