1 drop in each eye 4 times daily during waking hours; discard bottle 7 days after first opening
Corneal crystal score falls about 4.6 points over 90 days of four-times-daily dosing.
Contraindications
None.
Available Forms
5 mL viscous solution in a 10 mL amber glass bottle, 0.37% (3.8 mg/mL cysteamine base, 5.6 mg/mL as the hydrochloride), one separately wrapped dropper applicator per carton
Mechanism of Action
Cystine-depleting agent: converts cystine to cysteine and to cysteine-cysteamine mixed disulfides, reducing corneal cystine crystal accumulation. Systemic exposure from the ocular route is negligible, since the total daily ophthalmic dose is less than 4% of the recommended oral daily dose.
Warnings & Precautions
Benign intracranial hypertension: Reported with oral cysteamine and resolved with added diuretic therapy; every reported case with the ophthalmic route was in a patient concurrently on the oral drug.
Soft contact lenses: Benzalkonium chloride may be absorbed by soft lenses; avoid contact, remove lenses before instillation, and reinsert 15 minutes after.
Dropper contamination: Do not touch the tip to the eyelids, surrounding areas, or any surface; keep the bottle tightly closed when not in use.
In-use stability: Solution is only stable 7 days after first opening; discard at 7 days even if medication remains.
Common Side Effects
Ocular: Eye pain, blurred vision, eye irritation, ocular hyperemia, instillation site discomfort, eye pruritus, increased lacrimation, ocular deposits; each reported at 10% or greater.
Systemic: The label's 10% or greater list contains no systemic reactions; total daily ophthalmic dose is less than 4% of the recommended oral daily dose.
Pregnancy & Lactation
Pregnancy: No adequate and well-controlled studies of ophthalmic cysteamine in pregnant women; oral cysteamine through organogenesis in rats was teratogenic at 240 to 960 times the recommended human ophthalmic dose (intrauterine death, cleft palate, kyphosis, ventricular septal defects, microcephaly, exencephaly, growth deficits).
Lactation: No data on human milk, the breastfed infant, or milk production; cysteamine is present in the milk of orally dosed lactating rats.
Pediatric Use
Safety and effectiveness established in pediatric patients.