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Prescribing Information

 

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Dosage and Administration1

CYSTARAN is provided in a 15-mL bottle of sterile ophthalmic solution. Each mL contains
6.5 mg cysteamine hydrochloride or 4.4 mg of cysteamine.

The recommended administration is 1 drop instilled in each eye, every waking hour.
Click here to see the full Prescribing Information for CYSTARAN.

To minimize contamination, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. The bottle should be kept tightly closed when not in use.

Thawed CYSTARAN drops can be stored at 2°–25° C (36°–77° F) for up to 1 week. Do not refreeze. Discard the bottle after 7 days, even if there is still medication in it. CYSTARAN solution is only stable for 1 week.

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.

CYSTARAN is for ophthalmic use only.

For information about CYSTARAN, or to place an order, please call: 1‑877‑534‑9627.
For medical information about CYSTARAN, please call: 1‑866‑634‑2765.

Reference: 1. CYSTARAN [prescribing information]. Gaithersburg, MD: Sigma-Tau Pharmaceuticals, Inc; 2012.

Indication:

CYSTARAN (CYSTEAMINE OPHTHALMIC SOLUTION) 0.44% STERILE is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Important Safety Information:

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.

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.

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.

CYSTARAN is for topical ophthalmic use only.

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.