Trypan blue
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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Preparation and administration
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Dosage & Administration Cataract surgery. VisionBlue® 0.06% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL syringe to which a blunt cannula has to be attached. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue® 0.06% by the aqueous.
VisionBlue® 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed. Inject an air bubble into the anterior chamber; Carefully apply VisionBlue® 0.06% onto the lens capsule; Remove all excess dye from the anterior chamber.
Contraindications
Contraindications 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).
Pregnancy and lactation
Pregnancy
Pregnancy Risk Summary There are no available data on the use of VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of VisionBlue® 0.06% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with VisionBlue® 0.06%, however, trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA).
Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of VisionBlue® 0.06% will result in fetal exposure to the drug and risk of teratogenic effects. Animal Data 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.
Normalized to BSA, these doses are approximately 1,600- and 800-fold the maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. 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 3,200-fold the maximum recommended human dose based on BSA, assuming total absorption).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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