Cystadrops

CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. ( 1 )

None. None. ( 4 )

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 )

5.1Contamination 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.

5.2Benign 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.

5.3Contact Lens Use

CYSTADROPS contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration [see Patient Counseling Information ( 17 )] .

8.1Pregnancy 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 240 to 960 times the recommended human ophthalmic dose (based on body surface area) [ see Data ] . CYSTADROPS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.