Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.44% (Cystaran)
- 0.37% (Cystadrops)
Corneal Cystine Crystals
Cystine-depleting agent indicated for corneal cystine crystal accumulation in patients with cystinosis
Cystaran: Instill 1 drop in each eye, every waking hour (ie, q1hr while awake)
Cystadrops: Instill 1 drop in each eye, QID during waking hours
Dosage Modifications
Renal impairment
- Not evaluated
Dosage Forms & Strengths
ophthalmic solution
- 0.44% (Cystaran)
- 0.37% (Cystadrops)
Corneal Cystine Crystals
Cystine-depleting agent indicated for corneal cystine crystal accumulation in patients with cystinosis
Cystaran: Instill 1 drop in each eye, every waking hour (ie, q1hr while awake)
Cystadrops: Instill 1 drop in each eye, QID during waking hours
Dosage Modifications
Renal impairment
Not evaluated
Adverse Effects
>10%
Cystaran
- Sensitivity to light
- Redness
- Eye pain/irritation
- Headache
- Visual field defects
Cystadrops
- Eye pain
- Vision blurred
- Eye irritation
- Ocular hyperemia
- Instillation site discomfort
- Eye pruritus
- Lacrimation increased
- Ocular deposits
Warnings
Contraindications
None
Cautions
For topical ophthalmic use only
Avoid touching eyelids or surrounding areas with the dropper tip of the bottle to avoid contamination
Benign intracranial hypertension (pseudotumor cerebri) reported with cysteamine PO; there have also been reports associated with cysteamine ophthalmic, however, all of these patients were on concurrent cysteamine PO
Contains benzalkonium chloride, which may be absorbed by soft contact lenses; contact lenses should be removed prior to application and may be reinserted after 15 minutes
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies of ophthalmic cysteamine in pregnant females to inform any drug associated risks
Animal data
- Oral administration of cysteamine to pregnant rats throughout organogenesis was teratogenic at doses 240 to 960 times the recommended human ophthalmic dose (based on body surface area)
- Use during pregnancy only if potential benefit justifies potential risk to the fetus
Lactation
No information available regarding 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
Unknown whether measurable levels of cysteamine would be present in maternal milk following topical ocular administration
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Acts as a cystine–depleting agent by converting cystine to cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation
Absorption
Negligible; incremental increase in systemic cysteamine levels derived from cysteamine ophthalmic applied topically to the eye in patients treated with oral cysteamine was observed to be negligible
Administration
Ophthalmic Preparation
Wash hands carefully in order to avoid microbiological contamination
Do not touch opening of bottle or dropper
Cystaran
- Each week, remove one new bottle from the freezer
- Allow bottle to thaw completely (~24 hr) before use
Cystadrops
- Remove from refrigerator
- Remove green protective cap, metal seal, and gray stopper from the bottle
- Advise not to lose the small white cap that comes on the top of the dropper; keep the small white cap tightly closed when not in use
Ophthalmic Administration
Topical ophthalmic use only
Tilt head back
Pull down lower eyelid with a clean finger and look up; allow drop to go into the space between lower eyelid and eye
Do not touch dropper tip to the eyelids, surrounding areas, or any surface, as this may contaminate solution
Concomitant use with topical ocular products
- Allow an interval of 10 minutes between successive applications
- Administer eye ointments last
Contact lenses
- Remove before using drops
- Wait at least 15 minutes after using drops, before reinserting contact lenses back in eyes
Missed dose
- Administer a dose as soon as feasible and then continue treatment with next scheduled instillation
Storage
Cystadrops
- Unopened bottle: Refrigerate at 2-8ºC (36-46ºF) in the original carton
- Opened bottle: After first opening, store at room temperature at 20-25ºC (68-77ºF) for up to 7 days; do not refrigerate; discard after 7 days of use
Cystaran
- Unopened: Store in freezer at -25 to -15ºC (-13 to 5ºF) in the original carton
- Thawed bottle: Store at 2-25ºC (36-77ºF) for up to 7 days; do not refreeze; discard after 7 days of use
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.