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
Denavir Side Effects, and Drug Interactions - Penciclovir
Denavir Side Effects, and Drug Interactions - Penciclovir
SIDE EFFECTS
In two double-blind placebo-controlled trials, 1516 patients were treated
with Denavir (penciclovir cream) and 1541 with placebo. The most
frequently reported adverse event was headache, which occurred in 5.3%
of the patients treated with Denavir and 5.8% of the placebo-treated
patients. The rates of reported local adverse reactions are shown in Table
2 below. One or more local adverse reactions were reported by 2.7% of
the patients treated with Denavir and 3.9% of placebotreated patients.
| Table 2- Local Adverse
Reactions Reported in Phase III Trials |
| |
Penciclovir
n= 1516
% |
Placebo
n= 1541
% |
| Application site reaction |
1.3 |
1.8 |
| Hypesthesia/Local anesthesia |
0.9 |
1.4 |
| Taste perversion |
0.2 |
0.3 |
| Pruritus |
0.0 |
0.3 |
| Pain |
0.0 |
0.1 |
| Rash (erythematous) |
0.1 |
0.1 |
| Allergic reaction |
0.0 |
0.1 |
Two studies, enrolling 108 healthy subjects were conducted to evaluate
the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration
than the commercial formulation) compared to vehicle using repeated occluded
patch testing methodology. The 5% penciclovir cream induced mild erythema
in approximately one-half of the subjects exposed an irritancy profile
similar to the vehicle control in terms of severity and proportion of
subjects with a response. No evidence of sensitization was observed.
DRUG INTERACTIONS
No information provided.
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