Rx Item-Cystaran .44% Opthalmic Solution 15Ml

These highlights do not include all the information needed to use CYSTARAN� safely and effectively. See full prescribing information for CYSTARAN. CYSTARAN (cysteamine ophthalmic solution) 0.44%. Initial U.S. Approval: 1994 INDICATIONS AND USAGE CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. (1) DOSAGE AND ADMINISTRATION Instill one drop of CYSTARAN in each eye, every waking hour. (2) DOSAGE FORMS AND STRENGTHS Sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride equivalent to 4.4 mg/mL of cysteamine (0.44%). (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. (5.1) ADVERSE REACTIONS The most common adverse reactions (incidence approximately 10% or greater) are sensitivity to light, redness, eye pain/irritation, headache and visual field defects. (6) To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 7/2017

RX ITEM-Cystaran .44% Opthalmic Solution
CYSTARAN .44% OPTHALMIC SOL 15ML

Leadiant Biosciences, Inc.
BRAND: CYSTARAN NDC: RX54482-0020-01 ,RX54482002001 UPC: 354482-020019,354482020019 CYSTARAN .44% OPTHALMIC SOL 15ML

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