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
Inomax Side Effects, and Drug Interactions - Nitric Oxide
Inomax Side Effects, and Drug Interactions - Nitric Oxide
SIDE EFFECTS
Controlled studies have included 325 patients on INOmax doses
of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials
was 11% on placebo and 9% on INOmax, a result adequate to exclude INOmax mortality
being more than 40% worse than placebo.
In both the NINOS and CINRGI studies, the duration of hospitalization
was similar in INOmax and placebo-treated groups.
From all controlled studies, at least 6 months of follow-up
is available for 278 patients who received INOmax and 212 patients who received
placebo. Among these patients, there was no evidence of an adverse effect of
treatment on the need for rehospitalization, special medical services, pulmonary
disease, or neurological sequelae.
In the NINOS study, treatment groups were similar with respect
to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage,
periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant
therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.
The table below shows adverse events with an incidence of at
least 5% on INOmax in the CINRGI study, and that were more common on INOmax
than on placebo.
ADVERSE EVENTS IN THE CINRGI TRIAL
|
Adverse Event
|
Placebo (n=89)
|
Inhaled NO (n=97)
|
|
Hypotension
|
9 (10%)
|
13 (13%)
|
|
Withdrawal
|
9 (10%)
|
12 (12%)
|
|
Atelectasis
|
8 (9%)
|
9 (9%)
|
|
Hematuria
|
5 (6%)
|
8 (8%)
|
|
Hyperglycemia
|
6 (7%)
|
8 (8%)
|
|
Sepsis
|
2 (2%)
|
7 (7%)
|
|
Infection
|
3 (3%)
|
6 (6%)
|
|
Stridor
|
3 (3%)
|
5 (5%)
|
|
Cellulitis
|
0 (0%)
|
5 (5%)
|
DRUG INTERACTIONS
No formal drug-interaction studies have been performed, and
a clinically significant interaction with other medications used in the treatment
of hypoxic respiratory failure cannot be excluded based on the available data.
INOmax has been administered with tolazoline, dopamine, dobutamine, steroids,
surfactant, and high-frequency ventilation. Although there are no study data
to evaluate the possibility, nitric oxide donor compounds, including sodium
nitroprusside and nitroglycerin, may have an additive effect with INOmax on
the risk of developing methemoglobinemia. An association between prilocaine
and an increased risk of methaemoglobinaemia, particularly in infants, has specifically
been described in a literature case report. This risk is present whether the
drugs are administered as oral, parenteral, or topical formulations.
top
