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
Tilade Warnings, Precautions, Pregnancy, Nursing, Abuse - Nedocromil (inhalation)
Tilade Warnings, Precautions, Pregnancy, Nursing, Abuse - Nedocromil (inhalation)
WARNINGS
Tilade® Inhaler (nedocromil sodium inhalation
aerosol) is not a bronchodilator
and therefore, should
not be used for the reversal
of acute bronchospasm,
particularly status asthmaticus. Tilade should ordinarily be continued
during acute exacerbations,
unless the patient becomes
intolerant to the use of inhaled dosage
forms.
As with other inhaled asthma
medications, bronchospasm, which can be life-threatening, may occur
immediately after administration. If this occurs, Tilade should
be discontinued and alternative therapy
instituted.
PRECAUTIONS
General
The role of Tilade as
a corticosteroid-sparing agent
in patients receiving oral or inhaled corticosteroids remains to
be defined. If systemic
or inhaled corticosteroid therapy
is reduced in patients receiving Tilade, careful monitoring is necessary.
Information for Patients
Patients should be told that:
Tilade must be taken regularly to achieve benefit, even during
symptom-free periods.
Tilade is not meant to relieve
acute asthma
symptoms. If symptoms do not improve or the patient’s condition
worsens, the patient should not increase the dosage
but should notify the physician
immediately.
They should not decrease the dose
without the physician’s knowledge. The recommended dose
should not be exceeded.
The full therapeutic
effect of Tilade may
not be obtained for 1 week or longer after initiating treatment.
Because the therapeutic
effect depends upon local
delivery to the lungs, it is essential
that patients be properly instructed in the correct method
of use (see Patient Instructions for Use).
An illustrated leaflet for the patient
is included in each Tilade Inhaler pack.
Drug Interactions
In clinical studies,
Tilade has been co-administered with other anti-asthma medications,
including inhaled and oral
bronchodilators, and inhaled corticosteroids, with no
evidence of increased
frequency of adverse
events or laboratory abnormalities. No
formal drug-drug interaction studies, however, have been conducted.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A two-year inhalation
carcinogenicity study of nedocromil sodium
at a dose of 24 mg/kg/day
(approximately 8 times the maximum
recommended human daily inhalation
dose on a mg/m2
basis) in Wistar rats showed no carcinogenic
potential. A 21-month oral
dietary carcinogenicity
study of nedocromil sodium
performed in B6C3F1 mice with doses up to 180 mg/kg/day (approximately
30 times the maximum
recommended human daily
inhalation dose on a mg/m2 basis) showed no
carcinogenic potential.
Nedocromil sodium showed
no mutagenic potential
in the Ames Salmonella/microsome plate
assay, mitotic gene
conversion in Saccharomyces
cerevisiae, mouse
lymphoma forward mutation,
and mouse micronucleus
assays.
Reproduction and fertility
studies in mice and rats showed no
effects on male and female
fertility at a subcutaneous
dose of 100 mg/kg/day (approximately
30 times and 60 times, respectively, the maximum recommended human
daily inhalation
dose on a mg/m2
basis).
Pregnancy
Pregnancy Category B: Reproduction studies performed
in mice, rats, and rabbits using a subcutaneous
dose of 100 mg/kg/day (approximately
30 times, 60 times, and 116 times, respectively, the maximum
recommended human daily inhalation
dose on a mg/m2
basis) revealed no evidence
of teratogenicity or harm to the fetus
due to nedocromil sodium. There are, however, no
adequate and well-controlled studies in pregnant
women. Because animal
reproduction studies
are not always predictive of human response, this drug
should be used during pregnancy
only if clearly needed.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when Tilade is administered to
a nursing woman.
Pediatric Use
Safety data in normal
volunteers and asthmatic patients between the ages of 6 and 11 years
are available on a total of 311 children from U.S. clinical trials
and 192 children from foreign clinical
trials (total = 503) of 4-12 weeks duration. An
additional 225 children received Tilade for 40 weeks and 24 received
Tilade for 52 weeks.
The safety and effectiveness
of Tilade in children ages 6 through 11 have been established in
adequate and well-controlled clinical trials. (See CLINICAL PHARMACOLOGY:
CLINICAL STUDIES: Pediatric Studies.)
Use of Tilade in children ages 6 through 11 years is also supported
by evidence from adequate
and well-controlled studies of Tilade in adults.
The safety and effectiveness
of Tilade in patients below the age
of 6 years have not been established.
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