"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophtha"...
Single Patient Use Only
Do not use this container for more than one patient since NAVSTEL® (balanced salt ophthalmic solution) Solution does not contain a preservative.
Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of NAVSTEL® (balanced salt ophthalmic solution) Solution has not been investigated. The hypromellose in NAVSTEL (balanced salt ophthalmic solution) ® has been demonstrated to be non-mutagenic in the in vitro Ames assay and the bacterial reverse mutation assay. A similar modified cellulose polymer (methylcellulose) was also non-mutagenic at concentrations up to 5,000 mg/kg in the rat bone marrow cytogenic assay. Fertility studies have not been conducted with hypromellose; however, rats fed a diet of up to 5% methylcellulose had no significant adverse effects relative to reproductive function.
Use In Specific Populations
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. NAVSTEL (balanced salt ophthalmic solution) ® Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There have been no controlled studies addressing the safety of NAVSTEL (balanced salt ophthalmic solution) ® in lactating women. Caution should be exercised when NAVSTEL® (balanced salt ophthalmic solution) is administered to a nursing woman.
Safety and efficacy of NAVSTEL® (balanced salt ophthalmic solution) have been demonstrated in pediatric patients.
No overall differences in safety or effectiveness have been observed between elderly and other patients.
Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Navstel Information
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