This information is not for clinical use. These highlights do not include all the information needed to use Visionblue safely and effectively. Before taking Visionblue please consult with your doctor. See full prescribing information for Visionblue.

Indications And Usage

VisionBlue 0.06% - Indications & Usage Section VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VISIONBLUE® 0.06% safely and effectively. see full prescribing information for VISIONBLUE® 0.06%. VisionBlue® (trypan blue ophthalmic solution) 0.06% Initial U.S. Approval: 2004 VisionBlue® 0.06% is an acid di-azo group dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Does this card cost me anything?

NO - The Pharmacy Savings Card alone does not cost you anything

Dosage Forms And Strengths

VisionBlue 0.06% - Dosage forms & Strengths section VisionBlue® 0.06% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL. VisionBlue® (trypan blue ophthalmic solution) 0.06% in a volume of 0.5 mL.

Contraindications

VisionBlue 0.06% - Contraindications section VisionBlue® 0.06% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it. Insertion of a non-hydrated (dry-state), hydrophilic acrylic intraocular lens (IOL).

Warning and Cautions

VisionBlue 0.06% - Warnings and Precautions section Excessive staining: It is recommended that after injection all excess VisionBlue® 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber. Excessive staining: Excess VisionBlue® 0.06% should be removed from the eye immediately after staining.

Adverse Reactions

VisionBlue 0.06% - Adverse Reactions section Adverse reactions reported following use of VisionBlue® 0.06% include discoloration of high water content hydrogen intraocular lenses (see contraindications) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Inadvertent staining of the posterior lens capsule and vitreous face. To report SUSPECTEDcontact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Use In Specific Populations

VisionBlue 0.06% - Use in specific populations section Trypan blue should not be given to pregnant women. VisionBlue 0.06% - Pregnancy section Teratogenic Effects: Pregnancy Category C. Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. These doses are approximately 10,000- and 5,000-fold the maximum recommended human dose of 0.3 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 10,000-fold the maximum recommended human daily dose of 0.3 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. VisionBlue 0.06% - Nursing Mothers section 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 trypan blue is administered to a nursing woman. VisionBlue 0.06% - Pediatric use section The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients. VisionBlue 0.06% - Geriatric use section No overall differences in safety and effectiveness have been observed between elderly and younger patients.