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
Cardene Side Effects, and Drug Interactions - Nicardipine
Cardene Side Effects, and Drug Interactions - Nicardipine
SIDE EFFECTS
In multiple-dose U.S. and foreign controlled short-term (up to
three months) studies 1910 patients received nicardipine
HCl alone or in combination with other drugs. in these studies adverse
events were reported spontaneously; adverse experiences were generally
not serious but occasionally required dosage adjustment
and about 10% of patients left
the studies prematurely because of them. Peak responses were not
observed to be associated with adverse effects during clinical
trials, but physicians should be aware that adverse effects associated
with decreases in blood
pressure (tachycardia,
hypotension, etc.) could occur around the time
of the peak effect. Most adverse effects were expected consequences
of the vasodilator
effects of nicardipine HCl.
Angina
The incidence rates
of adverse effects in anginal patients were derived from multicenter,
controlled clinical
trials. Following are the rates of adverse effects for nicardipine
HCl (N=520) and placebo
(N=310), respectively, that occurred in 0.4% of patients or more.
These represent events considered probably drug-related by the investigator
(except for certain cardiovascular events which were recorded in
a different category). Where the frequency of adverse effects for
nicardipine HCl
and placebo is similar,
causal relationship is uncertain. The only dose-related effects
were pedal edema
and increased angina.
TABLE 3 - Nicardipine Hydrochloride, Adverse REACTIONS
|
Percent of Patients with Adverse Effects in Controlled
Studies (Incidence of discontinuations shown in parentheses)
|
| Adverse Experience |
Cardene |
Placebo |
| (N=520) |
(N=310) |
|
Pedal Edema
|
7.1 (0) |
0.3 (0) |
|
Dizziness
|
6.9 (1.2) |
0.6 (0) |
|
Headache
|
6.4 (0.6) |
2.6 (0) |
|
Asthenia
|
5.8 (0.4) |
2.6 (0) |
|
Flushing
|
5.6 (3.5) |
1.0 (0) |
|
Increased Angina
|
5.6 (3.5) |
4.2 (1.9) |
|
Palpitations
|
3.3 (0.4) |
0.0 (0) |
|
Nausea
|
1.9 (0) |
0.3 (0) |
|
Dyspepsia
|
1.5 (0.6) |
0.6 (0.3) |
|
Dry Mouth
|
1.4 (0) |
0.3 (0) |
|
Somnolence
|
1.4 (0) |
1.0 (0) |
|
Rash
|
1.2 (0.2) |
0.3 (0) |
|
Tachycardia
|
1.2 (0.2) |
0.6 (0) |
|
Myalgia
|
1.0 (0) |
0.0 (0) |
|
Other Edema
|
1.0 (0) |
0.0 (0) |
|
Paresthesia
|
1.0 (0.2) |
0.3 (0) |
|
Sustained Tachycardia
|
0.8 (0.6) |
0.0 (0) |
|
Syncope
|
0.8 (0.2) |
0.0 (0) |
|
Constipation
|
0.6 (0.2) |
0.6 (0) |
|
Dyspnea
|
0.6 (0) |
0.0 (0) |
|
Abnormal ECG
|
0.6 (0.6) |
0.0 (0) |
|
Malaise
|
0.6 (0) |
0.0 (0) |
|
Nervousness
|
0.6 (0) |
0.3 (0) |
|
Tremor
|
0.6 (0) |
0.0 (0) |
In addition, adverse events were observed which are not readily
distinguishable from the natural
history of the atherosclerotic
vascular disease
in these patients. Adverse events in this category each occurred
in <0.4% of patients receiving nicardipine
HCl and included myocardial
infarction, atrial fibrillation,
exertional hypotension,
pericarditis, heart
block, cerebral ischemia
and ventricular
tachycardia. it is possible that some of these events were drug-related.
Hypertension
The incidence rates
of adverse effects in hypertensive
patients were derived from multicenter, controlled clinical
trials. Following are the rates of adverse effects for nicardipine
HCl (N=1390) and placebo
(N=211), respectively, that occurred in 0.4% of patients or more.
These represent events considered probably drug-related by the investigator.
Where the frequency of adverse effects for nicardipine
HCl and placebo is similar,
causal relationship is uncertain. The only dose-related effect
was pedal edema.
TABLE 4 - Nicardipine Hydrochloride, Adverse
REACTIONS
|
Percent of Patients with Adverse Effects in Controlled
Studies (Incidence of discontinuations shown in parentheses)
|
| Adverse Experience |
Cardene |
Placebo |
| (N=1390) |
(N=211) |
| Flushing |
9.7 (2.1) |
2.8 (0) |
| Headache |
8.2 (2.6) |
4.7 (0) |
| Pedal Edema |
8.0 (1.8) |
0.9 (0) |
| Asthenia |
4.2 (1.7) |
0.5 (0) |
| Palpitations |
4.1 (1.0) |
0.0 (0) |
| Dizziness |
4.0 (1.8) |
0.0 (0) |
| Tachycardia |
3.4 (1.2) |
0.5 (0) |
| Nausea |
2.2 (0.9) |
0.9 (0) |
| Somnolence |
1.1 (0.1) |
0.0 (0) |
| Dyspepsia |
0.8 (0.3) |
0.5 (0) |
| Insomnia |
0.6 (0.1) |
0.0 (0) |
| Malaise |
0.6 (0.1) |
0.0 (0) |
| Other Edema |
0.6 (0.3) |
1.4 (0) |
| Abnormal Dreams |
0.4 (0) |
0.0 (0) |
| Dry mouth |
0.4 (0.1) |
0.0 (0) |
| Nocturia |
0.4 (0) |
0.0 (0) |
| Rash |
0.4 (0.4) |
0.0 (0) |
| Vomiting |
0.4 (0.4) |
0.0 (0) |
Rare Events
The following rare adverse events have been reported in clinical
trials or the literature:
Body as a Whole: infection,
allergic reaction
Cardiovascular: hypotension,
postural hypotension,
atypical chest
pain, peripheral vascular
disorder, ventricular
extrasystoles, ventricular
tachycardia
Digestive: sore
throat, abnormal
liver chemistries
Musculoskeletal: arthralgia
Nervous: hot
flashes, vertigo, hyperkinesia,
impotence, depression,
confusion, anxiety
Respiratory: rhinitis,
sinusitis
Special Senses: tinnitus,
abnormal vision, blurred
vision
Urogenital: increased urinary
frequency
DRUG INTERACTIONS
Beta-Blockers
In controlled clinical
studies, adrenergic
beta-receptor blockers have been frequently administered concomitantly
with nicardipine
HCl. The combination is well tolerated.
Cimetidine
Cimetidine increases nicardipine
HCl plasma levels. Patients
receiving the two drugs concomitantly should be carefully monitored.
Digoxin
Some calcium blockers
may increase the concentration
of digitalis preparations
in the blood. Nicardipine HCl usually does not alter the plasma
levels of digoxin, however, serum
digoxin levels should
be evaluated after concomitant therapy with nicardipine
HCl is initiated.
Maalox
Co-administration of Maalox TC had no
effect on nicardipine
HCl absorption.
Fentanyl Anesthesia
Severe hypotension
has been reported during fentanyl anesthesia
with concomitant use of a beta-blocker and a calcium
channel blocker. Even
though such interactions were not seen during clinical
studies with nicardipine HCl, an increased volume
of circulating fluids might be required if such an interaction were
to occur.
Cyclosporine
Concomitant administration
of nicardipine and
cyclosporine levels.
Plasma concentrations of cyclosporine
should therefore be closely monitored, and its dosage
reduced accordingly, in patients treated with nicardipine.
When therapeutic
concentrations of furosemide, propranolol, dipyridamole, warfarin,
quinidine, or naproxen were added to human
plasma (in vitro), the plasma
protein binding of nicardipine
HCl was not altered.
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