Cystaran (cysteamine HCl)

The dosage of cysteamine hydrochloride ophthalmic solution is expressed in terms of cysteamine.

For the treatment of corneal cystine crystal accumulation in adult and pediatric patients with cystinosis, the recommended dosage of cysteamine hydrochloride ophthalmic solution is 1 drop of a 0.44% solution in each eye every waking hour.

Continued ophthalmic cysteamine therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.

Cysteamine hydrochloride is applied topically to the eyes as an ophthalmic solution; the ophthalmic solution is for topical ophthalmic use only. To minimize the risk of contaminating the dropper tip and solution, care should be taken to avoid touching the eyelids, surrounding areas of the eye, or any other surface with the dropper tip of the bottle. The bottle containing the ophthalmic solution should be kept tightly closed when not in use. (See Advice to Patients.)

Cysteamine hydrochloride ophthalmic solution contains benzalkonium chloride, which may be absorbed by soft contact lenses. The manufacturer states that contact lenses should be removed prior to administration of each dose of the drug, but may be reinserted 15 minutes after the dose.

Cysteamine ophthalmic solution 0.44% contains 6.5 mg/mL of cysteamine hydrochloride (equivalent to 4.4 mg/mL of cysteamine) and is packaged in 15-mL bottles with a controlled dropper tip and a screw cap. Unopened bottles containing cysteamine ophthalmic solution should be stored frozen at -25degrees to -15degreesC in their original carton. Each week, a new bottle should be removed from the freezer. The bottle should be allowed to completely thaw for approximately 24 hours prior to use. The thawed bottle of the ophthalmic solution should then be stored at 2-25degreesC for up to 1 week and should not be refrozen. Each bottle should be discarded after 1 week of use. (See Advice to Patients.)

No dosing information is available for this tab.

There are no known drug interactions with ophthalmic administration of cysteamine hydrochloride. Clinically important drug interactions with systemically administered drugs are unlikely because of cysteamine's negligible systemic exposure following ophthalmic administration (see Description).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no known contraindications to the use of cysteamine hydrochloride ophthalmic solution.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects reported in 10% or more of patients receiving cysteamine hydrochloride ophthalmic solution include photophobia (sensitivity to light), ocular (including conjunctival) redness, ocular pain and/or irritation, headache, and visual field defects.

There are no severe adverse reactions for this drug.

More Frequent

• Headache disorder
• Ocular irritation
• Ocular pain
• Ocular redness
• Photophobia
• Visual field defect

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The safety and efficacy of cysteamine hydrochloride ophthalmic solution in pediatric patients have been established, and the drug is labeled for use in such patients. The majority of patients in the ophthalmic cysteamine clinical trials were pediatric patients. (See Uses: Corneal Cystine Crystal Accumulation.)

Category C. (See Users Guide.)

It is not known whether oral cysteamine is distributed into human milk. The manufacturer states that the incremental increase in systemic cysteamine concentrations resulting from ophthalmic administration of cysteamine in patients receiving oral cysteamine is negligible. However, because of the potential for serious adverse reactions to cysteamine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

When the controlled clinical studies of cysteamine hydrochloride ophthalmic solution were conducted, the reduced life expectancy from cystinosis did not make it possible to include geriatric patients in the study population.