No information provided.
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.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
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).
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® (nedocromil) ophthalmic solution should
be used during pregnancy only if clearly needed.
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® (nedocromil)
ophthalmic solution is administered to a nursing woman.
Safety and effectiveness in children below the age of 3 years have not been established.
No overall differences in safety or effectiveness have been observed between
elderly and younger patients.