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Medications›Misc.›Cystaran

Cystaran®

GoodRx

Cysteamine 0.44% · ophthalmic solution

Misc.

Approved uses

Corneal cystine crystal accumulation in cystinosis

1 drop in each eye every waking hour; discard 1 week after the foil and bottle are opened

Corneal crystals dissolve over 8 to 41 months, so counsel months rather than weeks.

Contraindications

None.

Available Forms

Ophthalmic solution, 15 mL foil-wrapped LDPE bottle, 0.44% (4.4 mg/mL cysteamine base, 6.5 mg/mL as the hydrochloride), supplied as a frozen-storage presentation and a refrigerated-storage presentation

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 2% 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.

Other forms of Cysteamine

Cystadrops®

Other Misc. drugs

Actemra®
Betadine® 5%
Botox®
CellCept®
Epioxa®
Fluorouracil
Humira®
Imuran®

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Soft contact lenses: Benzalkonium chloride may be absorbed by soft lenses; 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 1 week after the foil and bottle are opened; record the discard date and discard at 1 week even if medication remains.

Cold chain: The frozen presentation needs roughly 24 hours to thaw before the first dose and must never be refrozen; the thawed bottle needs no refrigeration between doses during its week of use.

Common Side Effects

Ocular: Sensitivity to light, redness, eye pain/irritation, visual field defects; each at approximately 10% or greater.
Systemic: Headache at approximately 10% or greater.
Exposure basis: Safety data reflect approximately 300 patients in controlled trials of 6 months to 19 years duration.

Pregnancy & Lactation

Pregnancy: No adequate and well controlled studies of ophthalmic cysteamine in pregnant women; oral cysteamine through organogenesis in rats was teratogenic at 86 to 345 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.

Cystaran (Cysteamine 0.44%) | EyeKnow O.D.