FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. As with all ophthalmic
preparations containing benzalkonium chloride, patients should be instructed not to wear soft contact
lenses during treatment with ALOMIDE® Ophthalmic Solution. Do not touch the dropper tip to any
surface, as this may contaminate the solution.
Patients may experience a transient burning or stinging upon instillation of ALOMIDE® Ophthalmic
Solution. Should these symptoms persist, the patient should be advised to contact the prescribing
Carcinogenesis, Mutagenesis, Impairment Of Fertility
A long-term study with lodoxamide tromethamine in rats (two-year oral administration) showed no
neoplastic or tumorigenic effects at doses 100 mg/kg/day (more than 5000 times the proposed human
clinical dose). No evidence of mutagenicity or genetic damage was seen in the Ames Salmonella Assay,
Chromosomal Aberration in CHO Cells Assay, or Mouse Forward Lymphoma Assay. In the BALB/c-
3T3 Cells Transformation Assay, some increase in the number of transformed foci was seen at high
concentrations (greater than 4000 μg/mL). No evidence of impairment of reproductive function was
shown in laboratory animal studies.
Pregnancy Category B
Reproduction studies with lodoxamide tromethamine administered orally to rats and rabbits in doses of
100 mg/kg/day (more than 5000 times the proposed human clinical dose) produced no evidence of
developmental toxicity. There are, however, no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always predictive of human response,
ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1% should be used during pregnancy
only if clearly needed.
It is not known whether lodoxamide tromethamine is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when ALOMIDE® Ophthalmic Solution 0.1% is
administered to nursing women.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger