"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
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® (lodoxamide tromethamine) Ophthalmic Solution. Do not touch the dropper tip to any surface, as this may contaminate the solution.
General: Patients may experience a transient burning or stinging upon instillation of ALOMIDE® (lodoxamide tromethamine) Ophthalmic Solution. Should these symptoms persist, the patient should be advised to contact the prescribing physician.
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 SalmonellaAssay, 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: 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.
Nursing Mothers: 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® (lodoxamide tromethamine) Ophthalmic Solution 0.1% is administered to nursing women.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.
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