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
Infasurf Side Effects, and Drug Interactions - Calfactant
Infasurf Side Effects, and Drug Interactions - Calfactant
SIDE EFFECTS
The most common adverse reactions associated with Infasurf dosing procedures
in the controlled trials were: cyanosis
(65%), airway obstruction
(39%), bradycardia (34%), reflux
of surfactant into the
endotracheal t.b. (21%), requirement
for manual ventilation
(16%), and reintubation (3%). These events were generally transient
and not associated with serious complications or death.
The incidence of common
complications of prematurity
and RDS in the four controlled
Infasurf trials are presented in Table 3. Prophylaxis and treatment study
results for each surfactant
are combined.
Table 3 - Common Complications of Prematurity and RDS
in Controlled Trials
|
Complication
|
Infasurf
|
Exosurf
Neonatal®
|
Infasurf
|
Survanta®
|
|
|
(N=1001)
|
(N=
978)
|
(N=553)
|
(N=
566)
|
| |
%
|
%
|
%
|
%
|
| Apnea
|
61
|
61
|
76
|
76
|
| Patent
ductus arteriosus |
47
|
48
|
45
|
48
|
| Intracranial
hemorrhage |
29
|
31
|
36
|
36
|
| Severe
intracranial hemorrhage
a |
12
|
10
|
9
|
7
|
| IVH
and PVL b |
7
|
3
|
5
|
5
|
| Sepsis
|
20
|
22
|
28
|
27
|
| Pulmonary
air leaks |
12
|
22
|
15
|
15
|
| Pulmonary
interstitial emphysema |
7
|
17
|
10
|
10
|
| Pulmonary
hemorrhage |
7
|
7
|
7
|
6
|
| Necrotizing
enterocolitis |
5
|
5
|
17
|
18
|
| a
Grade III and IV by the method
of Papile. |
| b
Combined incidence
of intraventricular
hemorrhage and periventricular
leukomalacia. |
Follow-up Evaluations
Two-year follow-up data
of neurodevelopmental outcomes in 415 infants enrolled at 5 centers that
participated in the Infasurf versus Exosurf Neonatal® controlled trials
demonstrated significant
developmental delays in equal percentages of Infasurf and Exosurf Neonatal®
patients.
DRUG INTERACTIONS
No infromation provided.
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