What is the dosage of Cystaran?

Cystaran is available in 1 dosages, including 0.44% Sol

What is Cystaran made of?

Cystaran contains cysteamine which is a Cystine Depleting Agent

How is Cystaran administered?

Cystaran is administered as a Ophthalmic

What is Cystaran mechanism of action?

Cystaran mechanism of action is Cystine Disulfide Reduction

Cystaran

(cysteamine)

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Dosage & Administration

Instill one drop of CYSTARAN in each eye, every waking hour.

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Cystaran Prescribing Information

Pregnancy

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 86 to 345 times the recommended human ophthalmic dose (based on body surface area) [see Data]. CYSTARAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data

Animal Data

Teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (86 to 345 times the recommended human ophthalmic dose based on a body surface area) and have revealed cysteamine bitartrate to be teratogenic. Observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits.

Lactation

Risk Summary

There is no information regarding the presence of cysteamine in human milk, the effects on the breastfed infants, or the effects on milk production. Cysteamine administered orally is present in milk of lactating rats. It is not known whether measurable levels of cysteamine would be present in maternal milk following topical ocular administration of CYSTARAN.

Pediatric Use

The safety and effectiveness of CYSTARAN (cysteamine ophthalmic solution) 0.44% have been established in pediatric patients.

Geriatric Use

When the clinical studies with CYSTARAN were conducted, the reduced life expectancy from cystinosis did not make it possible to include patients in the geriatric age range.

Renal Impairment

The effect of renal impairment on the pharmacokinetics of cysteamine following ophthalmic administration of cysteamine ophthalmic solution has not been evaluated because ophthalmic exposure compared to systemic exposure is negligible. The majority of the patients in the ophthalmic clinical studies are assumed to have had some degree of renal impairment due to their underlying systemic disease. The total daily ophthalmic dose is less than 2% of the recommended oral daily dose of cysteamine; thus, the systemic exposure following ophthalmic administration is expected to be negligible compared to oral administration.

Contamination 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.

Benign 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.

Contact Lens Use

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 [see Patient Counseling Information (17)].

Cystaran

Dosage & Administration

Cystaran Prescribing Information

Pregnancy

Lactation

Pediatric Use

Geriatric Use

Renal Impairment

Contamination of Tip and Solution

Benign Intracranial Hypertension

Contact Lens Use

Topical Ophthalmic Use

Cystaran Prior Authorization Resources

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