Cystaran Drug Information
Generic name: CYSTEAMINE HYDROCHLORIDE
Uses of Cystaran
® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Dosage & Administration of Cystaran
Instill one drop of CYSTARAN in each eye, every waking hour. Do not touch dropper tip to any surface, as this may contaminate the solution. Discard after 1 week of use.
Instill one drop of CYSTARAN in each eye, every waking hour.
Side Effects of Cystaran
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 data described below reflect exposure in controlled clinical trials of six months to 19 years duration in approximately 300 patients. The most frequently reported ocular adverse reactions occurring in ≥10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.
Warnings & Cautions for Cystaran
Contamination of Tip and Solution To minimize contaminating the dropper tip and
solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
Benign Intracranial Hypertension
There have been reports of benign intracranial hypertension (or pseudotumor cerebri) associated with oral cysteamine treatment that has resolved with the addition of diuretic therapy. There have also been reports associated with ophthalmic use of cysteamine; however, all of these patients were on concurrent oral cysteamine.
Contact Lens Use
CYSTARAN contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration .
Topical Ophthalmic Use
CYSTARAN is for topical ophthalmic use.
Pregnancy Safety for Cystaran
Pregnancy Risk Summary There are no adequate and well controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks. Oral administration of cysteamine to pregnant rats throughout the period of organogenesis was teratogenic at doses 86 to 345 times the recommended human ophthalmic dose (based on body surface area) . CYSTARAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data Teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (86 to 345 times the recommended human ophthalmic dose based on a body surface area) and have revealed cysteamine bitartrate to be teratogenic.
Observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits.
Pediatric Use of Cystaran
Pediatric Use The safety and effectiveness of CYSTARAN (cysteamine ophthalmic solution) 0.44% have been established in pediatric patients.
Clinical Studies of Cystaran
Clinical efficacy was evaluated in controlled clinical trials in approximately 300 patients. The primary efficacy end point was the response rate of eyes that had a reduction of at least 1 unit in the photo-rated Corneal Cystine Crystal Score (CCCS) at some time point during the study when baseline CCCS ≥1, or a lack of an increase of more than 1 unit in CCCS throughout the study when baseline CCCS <1. Study 1 combined the data from three smaller studies. For eyes with a lower baseline of CCCS <1, the response rate was 13% (4/30). For eyes with a higher baseline of CCCS ≥1, the response rate was 32% (94/291). Study 2 evaluated ocular cystinosis patients who had a baseline of CCCS ≥1. The response rate was 67% (10/15). Study 3 also evaluated ocular cystinosis patients; for eyes with a baseline of CCCS ≥1, the response rate was 33% (3/9). Corneal crystals accumulate if CYSTARAN is discontinued.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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