WARNINGS
No Information Provided.
PRECAUTIONS
Information for Patients
Patients should be advised to follow the patient instructions
listed on the Information for Patients sheet.
Users of contact lenses should refrain from wearing lenses
while exhibiting the signs and symptoms of allergic conjunctivitis.
Carcinogenesis, Mutagenesis, and Impairment of
Fertility
A two-year inhalation carcinogenicity study of nedocromil
sodium at a dose of 24 mg/kg/day (approximately 400 times
the maximum recommended human daily ocular dose on a mg/kg
basis) in Wistar rats 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 (more than 1600 times the maximum
recommended human daily ocular dose).
Pregnancy: Teratogenic Effects: Pregnancy Category
B
Reproduction studies performed in mice, rats and rabbits
using a subcutaneous dose of 100 mg/kg/day (more than
1600 times the maximum human daily ocular dose on a mg/kg
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, ALOCRIL™ should be used during
pregnancy only if clearly needed.
Nursing Mothers
After intravenous administration to lactating rats, nedocromil
was excreted in milk. 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 ALOCRIL™
is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of
3 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness have
been observed between elderly and younger patients.
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