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
Nimotop Side Effects, and Drug Interactions - Nimodipine
Nimotop Side Effects, and Drug Interactions - Nimodipine
SIDE EFFECTS
Adverse experiences were reported by 92 of 823 patients with subarachnoid
hemorrhage (11.2%) who were given nimodipine. The most frequently
reported adverse experience
was decreased blood pressure
in 4.4% of these patients. Twenty nine of 479 (6.1%) placebo
treated patients also reported adverse experiences. The events reported
with a frequency greater
than 1% are displayed below by dose.
|
DOSE q4h
|
|
Number of Patients (%)
|
|
Nimodipine
|
Placebo
|
| Sign/Symptom |
0.35 mg/kg
(n=82)
|
30 mg
(n=71)
|
60 mg
n=(494)
|
90 mg
(n=172)
|
120 mg
(n=4)
|
(n=479)
|
| Decrease Blood Pressure |
1(1.2)
|
0
|
19 (3.8)
|
14 (8.1)
|
2 (50.0)
|
6 (1.2)
|
| Abnormal Liver Function
Test |
1 (1.2)
|
0
|
2 (0.4)
|
1 (0.6)
|
0
|
7 (1.5)
|
| Edema |
0
|
0
|
2 (0.4)
|
2 (1.2)
|
0
|
3 (0.6)
|
| Diarrhea |
0
|
3 (4.2)
|
0
|
3 (1.7)
|
0
|
3 (0.6)
|
| Rash |
2 (2.4)
|
0
|
3 (0.6)
|
2 (1.2)
|
0
|
3 (0.6)
|
| Headache |
0
|
1 (1.4)
|
6 (1.2)
|
0
|
0
|
1 (0.2)
|
| Gastrointestinal
Symptoms |
2 (2.4 )
|
0
|
0
|
2 (1.2)
|
0
|
0
|
| Nausea |
1 (1.2)
|
1 (1.4)
|
6 (1.2)
|
1 (0.6)
|
0
|
0
|
| Dyspnea |
1(1.2)
|
0
|
0
|
0
|
0
|
0
|
| EKG Abnormalities |
0
|
1 (1.4)
|
0
|
1 (0.6)
|
0
|
0
|
| Tachycardia |
0
|
1 (1.4)
|
0
|
0
|
0
|
0
|
| Bradycardia |
0
|
0
|
5 (1.0)
|
1 (0.6)
|
0
|
0
|
| Muscle Pain/Cramp |
0
|
1 (1.4)
|
1(0.2)
|
1 (0.6)
|
0
|
0
|
| Acne |
0
|
1 (1.4)
|
0
|
0
|
0
|
0
|
| Depression |
0
|
1 (1.4)
|
0
|
0
|
0
|
0
|
There were no other adverse
experiences reported by the patients who were given 0.35 mg/kg/
q.h. 30 mg
q4h or 120 mg q.h.
Adverse experiences with an incidence
rate of less than 1% in
the 60 mg q4h dose
group were: hepatitis;
itching; gastrointestinal; hemorrhage; thrombocytopenia; anemia;
palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin;
toxicity; lightheadedness; dizziness; rebound; vasospasm; jaundice;
hypertension; hematoma.
Adverse experiences with an incidence
rate less than 1% in the
90 mg q4h dose group
were itching; gastrointestinal
hemorrhage; thrombocytopenia; neurological deterioration; vomiting;
diaphoresis; congestive heart
failure; hyponatremia; decreasing platelet
count; disseminated
intravascular
coagulation; deep vein
thrombosis.
As can be seen from the table, side
effects that appear related to nimodipine use based on increased
incidence with higher
dose or a higher rate
compared to placebo
control, included decreased
blood pressure,
edema and headaches which
are known pharmacologic actions of calcium
channel blockers. It
must be noted, however, that SAH is frequently accompanied by alterations
in consciousness which lead
to an under reporting of adverse experiences. Patients who received
nimodipine in clinical
trials for other indications reported flushing (2.1%) headache
(4.1%) and fluid retention
(0.3%) typical responses to calcium
channel blockers. As
a calcium channel
blocker, nimodipine may have the potential
to exacerbate heart failure
in susceptible patients
or to interfere with A-V
conduction but these
events were not observed.
No clinically significant
effects on hematologic factors, renal
or hepatic function or carbohydrate
metabolism have been
causally associated with oral nimodipine. Isolated cases of non-fasting
elevated serum glucose
levels (0.8%), elevated LDH
levels (0.4%), decreased platelet
counts (0.3%), elevated alkaline phosphatase
levels (0.2%), and elevated SGPT
levels (0.2%) have been reported rarely.
DRUG ABUSE AND DEPENDENCE
There have been no reported
instances of drug abuse
or dependence with
Nimotop.
DRUG INTERACTIONS
It is possible that the cardiovascular
action of other calcium
channel blockers could be enhanced by the addition
of NimotopÒ.
In Europe, NimotopÒ
was observed to occasionally intensify the effect
of antihypertensive
compounds taken concomitantly by patients suffering from hypertension;
this phenomenon was not observed in North American clinical
trials.
A study in eight healthy
volunteers has shown a 50% increase in mean peak nimodipine plasma
concentrations and a 90% increase in mean
area under the curve, after
a one week course of cimetidine
at 1,000 mg/day and nimodipine at 90 mg/day. This effect
may be mediated by the known inhibition
of hepatic cytochrome P- 450 by cimetidine, which could decrease
first pass metabolism of nimodipine.
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