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
Fluticasone Side Effects, and Drug Interactions - Fluticasone Propionate
Fluticasone Side Effects, and Drug Interactions - Fluticasone Propionate
SIDE EFFECTS
In controlled clinical
trials (of twice daily administration
for fluticasone propionate cream), the total incidence
of adverse reactions associated with the use of fluticasone propionate
cream, 0.05% and ointment, 0.005% was approximately 4%. These adverse
reactions were usually mild, self-limiting, and for fluticasone
propionate cream consisted
primarily of pruritus, dryness, numbness of fingers, and burning.
These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients,
respectively. For fluticasone propionate ointment, the adverse reactions
consisted primarily of pruritus, burning, hypertrichosis, increased
erythema, hives, irritation, and lightheadedness. Each of these
events occurred individually in less than 1% of patients.
The following additional local
adverse reactions have been reported infrequently with topical
corticosteroids including fluticasone propionate and they may occur
more frequently with the use of occlusive
dressings and higher potency corticosteroids. These reactions are
listed in an approximately decreasing order
of occurrence: irritation
(dryness for ointment), folliculitis, acneiform eruptions, hypopigmentation,
perioral dermatitis,
allergic contact dermatitis,
secondary infection, skin
atrophy, striae and miliaria. Also, there are reports of the development
of pustular psoriasis
from chronic plaque psoriasis
following reduction
or discontinuation of potent
topical corticosteroid products.
Additional Information for Cream Only: Two clinical
studies compared once to twice daily administration
of fluticasone propionate cream for the treatment
of moderate to severe eczema. The local
drug-related adverse events for the 491 patients enrolled in both
studies are shown in TABLE 5. In
the study enrolling both adult
and pediatric patients,
the incidence of local
adverse events in the 119 pediatric
patients ages 1 to 12 years was comparable to the 140 patients ages
13 to 62 years.
Fifty-one pediatric
patients ages 3 months to 5 years, with moderate to severe eczema,
were enrolled in an open-label HPA axis
safety study. Fluticasone propionate cream
was applied twice daily for 3 to 4 weeks over an arithmetic mean
body surface area
of 64% (range 35-95%). The mean
morning cortisol levels
with standard deviations
before treatment (pre-stimulation mean
value = 13.76 ±
6.94 mcg/dl, post-stimulation mean
value = 30.53 ±
7.23 mcg/dl) and at end
treatment (pre-stimulation
mean value
= 12.32 ± 6.92 mcg/dl, post-stimulation
mean value
= 28.84 ± 7.16 mcg/dl) showed
little change. In 2 of 43
(4.7%) patients with end-treatment results, peak cortisol
levels following cosyntropin
stimulation testing
were £18 mcg/dl indicating adrenal
suppression. Follow-up testing after treatment
discontinuation, available for one of the two subjects, demonstrated
a normally responsive HPA axis. Local drug-related adverse events
were: transient burning,
resolving the same day it was reported; transient urticaria, resolving
the same day it was reported; erythematous rash; dusky erythema,
resolving within one month after cessation of fluticasone propionate
cream; and telangiectasia
resolving within 3 months after stopping fluticasone propionate
cream (see TABLE 6).
| TABLE 5 Drug-Related Adverse Events¾Skin |
| Adverse Events |
Fluticasone Once Daily (n=210) |
Fluticasone Twice Daily (n=203) |
Vehicle Twice Daily (n=78) |
| Skin infection |
1 (0.5%) |
|
|
| Infected eczema |
1 (0.5%) |
2 (1.0%) |
|
| Viral warts |
|
1 (0.5%) |
|
| Herpes simplex |
|
1 (0.5%) |
|
| Impetigo |
1 (0.5%) |
|
|
| Atopic dermatitis |
1 (0.5%) |
|
|
| Eczema |
1 (0.5%) |
|
|
| Exacerbation of eczema |
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
| Erythema |
|
2 (1.0%) |
|
| Burning |
2 (1.0%) |
2 (1.0%) |
2 (2.6%) |
| Stinging |
|
2 (1.0%) |
1 (1.3%) |
| Skin Irritation |
6 (2.9%) |
2 (1.0%) |
|
| Pruritis |
2 (1.0%) |
4 (1.9%) |
4 (5.1%) |
| Exacerbation of Pruritis |
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
| Folliculitis |
1 (0.5%) |
1 (0.5%) |
|
| Blisters |
|
1 (0.5%) |
|
| Dryness of skin |
3 (1.4%) |
1 (0.5%) |
|
| TABLE 6 Adverse Events* from Pediatric
Open-label Trial (n=51) |
| Adverse Events |
Fluticasone Twice Daily |
| Burning |
1 (2.0%) |
| Dusky Erythema |
1 (2.0%) |
| Erythematous Rash |
1 (2.0%) |
| Facial Telangiectasia† |
2 (4.9%) |
| Non Facial Telangiectasia |
1 (2.0%) |
| Uticaria |
1 (2.0%) |
| * See text for additional detail. |
| † n = 41. |
DRUG INTERACTIONS
No infromation provided.
top
