Use of topical NSAIDs in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
It is recommended that Xirom eye drops should be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Xirom eye drops should not be administered while wearing contact lenses.
Use in children: Safety and efficacy in pediatric patients have not been established.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when Xirom eye drops is administered to a nursing woman.