CORRECT USE OF PROPAFENONE
A
multicentre study(23) was recently carried out
on 349 patients to evaluate the safety of Propafenone in
patients with recent onset atrial fibrillation. The drug
was administered by an intravenous bolus of 2 mg/kg in 10
minutes with a subsequent infusion of 0.007 mg/kg for a
maximum duration of two hours. The following adverse
effects were observed (Table 6).
TABLE
6
Incidence of adverse effects
after intravenous Propafenone administration in
the acute treatment of recent onset atrial
fibrillation
|
Adverse effects
|
Number
of patients
|
%
|
| absent |
313
|
89.7
|
| present |
23
|
6.6
|
| no data |
13
|
3.7
|
Type
|
Number of events
|
%
|
| metallic
taste |
14
|
4.2
|
| sickness |
6
|
1.8
|
| visual
disturbance |
1
|
0.3
|
| headache |
6
|
1.8
|
| gastrointestinal
disturbance |
4
|
1.2
|
| hypotension |
11
|
3.2
|
| 2:1 atrial
flutter |
1
|
0.3
|
| premature
ventricular beats |
1
|
0.3
|
| 2nd degree
AV block |
1
|
0.3
|
| bradycardia |
1
|
0.3
|
| bradycardia
and hypotension |
1
|
0.3
|
| other |
4
|
1.2
|
All
the effect described were of short duration. The
clinically most important adverse effect was hypotension,
which was generally moderate, and in only one case was
Dopamine administration necessary.
The
adverse effects associated with long term treatment with
Propafenone are generally mild, and are usually
dose-dependent. They can often be resolved by reducing
the dosage, and only rarely require drug discontinuation
(Table 7).
TABLE
7
| Incidence
of adverse effects of Propafenone, related to the
daily dose (69) |
| Cardiovascular system |
450 mg |
600 mg |
900 mg |
| Ventricular tachycardia Dyspnoea
Angina
Congestive
heart failure
1st
degree AV block
Slowing
of intraventricular conduction
Palpitations
Syncope
Bundle
branch block
Increase
in PVBs
|
2.7% 1.9
1.3
1.1
0.9
0.8
0.5
0.5
0.4
0.8
|
2.2% 2.1
1.4
1.2
1.2
1.6
1.2
0.8
1.0
0.5
|
3.4% 2.8
2.8
2.6
2.5
2.1
1.9
1.1
1.2
0.6
|
| Central
nervous system |
| Dizziness Blurred
vision
Headache
Ataxia
Insomnia
Drowsiness
|
3.2% 0.5
1.5
0.2
0.1
0.6
|
5.6% 2.7
1.9
0.8
1.4
0.5
|
12.5% 3.2
2.5
1.7
0.6
0.7
|
| Gastrointestinal
system |
| Nausea and/or vomiting Metallic
taste
Stypsis
Dyspepsia
Dryness
of the mouth
Diarrhoea
Anorexia
Abdominal
pain/cramps
Flatulence
|
3.2% 2.7
1.5
1.1
0.9
0.4
0.4
0.7
0.1
|
4.7% 5.1
3.9
1.6
1.3
1.4
0.8
0.8
0.9
|
8.0% 6.4
4.3
2.2
1.6
1.5
1.0
1.0
0.8
|
| Miscellaneous |
| Easily tired Wakness
Rash
Anxiety
Atipical
chest pain
|
1.5% 0.4
0.5
0.9
0.3
|
1.8% 1.4
1.0
0.6
0.5
|
2.9% 1.7
1.6
1.1
1.0
|
A proarrhythmic
effect, common to all Class 1C drugs, is broad QRS
tachycardia due to "slowed" atrial flutter, 1:1
atrioventricular conduction, and frequency-dependent QRS
lengthening.
Such an electrocardiographic picture can be
indistinguishable from that of a ventricular tachycardia
and usually requires to be terminated by DC shock.
In addition, there are
very rare reports of granulocytopenia, agranulocytosis,
colestasis, Lupus-like syndrome; the majority of these
have been resolved after Propafenone discontinuation.
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