photrexa viscous in dextran 20%/photrexa
Photrexa Viscous in Dextran 20%/Photrexa is a combination medicine containing Riboflavin 5'-Phosphate and Riboflavin 5'-Phosphate Sodium.
Riboflavin 5'-Phosphate and Riboflavin 5'-Phosphate Sodium · by Glaukos
Key facts
What is Photrexa Viscous in Dextran 20%/Photrexa?
From the FDA label:PHOTREXA VISCOUS (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5'-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. PHOTREXA VISCOUS and PHOTREXA are supplied as: PHOTREXA VISCOUS in a 3 mL glass syringe containing sterile 1.56 mg/mL riboflavin 5'-phosphate in 20% dextran ophthalmic solution for topical administration. PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL riboflavin 5'-phosphate ophthalmic solution for topical administration. PHOTREXA VISCOUS (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% is a yellow sterile buffered viscous solution containing 1.56 mg/mL riboflavin 5'-phosphate and 20% dextran. The pH of the solution is approximately 7.1 and the osmolality is 284-368 mOsm/kg. Each 1 mL of solution contains 1.64 mg of riboflavin 5'-phosphate sodium (equivalent to 1.284 mg riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, dextran, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. PHOTREXA (riboflavin 5'-phosphate ophthalmic…
How to use
Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of PHOTREXA VISCOUS topically on the eye every 2 minutes for 30 minutes. At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of PHOTREXA VISCOUS every 2 minutes for an additional 2 to 3 drops and recheck for the presence of a yellow flare. This process can be repeated as necessary. Once the yellow flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns. Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen. Irradiate the eye for 30 continuous minutes at 3mW/cm 2 at a wavelength of 365 nm, centered over the cornea, using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of PHOTREXA VISCOUS onto the eye every 2 minutes for the 30 minute irradiation period. For topical ophthalmic use. Do not inject. Single use PHOTREXA VISCOUS and PHOTREXA only. Discard syringe(s) after use. PHOTREXA VISCOUS and PHOTREXA are for use with the…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Ulcerative keratitis [ Warnings and Precautions (Section 5) ] In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision ( 6.1 ). In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avedro at 1-844-528-3376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of the corneal collagen cross-linking procedure was evaluated in 3 randomized, parallel-group, open-label, sham-controlled trials; patients were followed up for 12 months. Study 1 enrolled patients with progressive keratoconus or corneal ectasia following refractive surgery. Study 2 enrolled only patients with…
Warnings
Important safety information
Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. [See Adverse Reactions (6) ] . Ulcerative keratitis can occur. Monitor for resolution of epithelial defects ( 5 )
Who should not take Photrexa Viscous in Dextran 20%/Photrexa
None. None ( 4 )
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Photrexa Viscous in Dextran 20%/Photrexa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Photrexa Viscous in Dextran 20%/Photrexa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Photrexa Viscous in Dextran 20%/Photrexa?
- Photrexa Viscous in Dextran 20%/Photrexa is marketed by Glaukos. You can see Glaukos's full profile, rating, and other products on pharmaranks.
- Is Photrexa Viscous in Dextran 20%/Photrexa a brand-name or generic drug?
- Photrexa Viscous in Dextran 20%/Photrexa is a brand-name product with the active ingredient Riboflavin 5'-Phosphate and Riboflavin 5'-Phosphate Sodium.
- Is Photrexa Viscous in Dextran 20%/Photrexa available over the counter?
- No. Photrexa Viscous in Dextran 20%/Photrexa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Photrexa Viscous in Dextran 20%/Photrexa come in?
- Photrexa Viscous in Dextran 20%/Photrexa is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Photrexa Viscous in Dextran 20%/Photrexa FDA-registered?
- Photrexa Viscous in Dextran 20%/Photrexa is on record with the U.S. FDA under application number NDA203324. You can verify this on its official FDA label.
- Is Photrexa Viscous in Dextran 20%/Photrexa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Photrexa Viscous in Dextran 20%/Photrexa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Photrexa Viscous in Dextran 20%/Photrexa?
- Photrexa Viscous in Dextran 20%/Photrexa's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Ulcerative keratitis [ Warnings and Precautions (Section 5) ] In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze),… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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