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Cysteamine (ophthalmic): Drug information

Cysteamine (ophthalmic): Drug information
(For additional information see "Cysteamine (ophthalmic): Patient drug information" and see "Cysteamine (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cystadrops;
  • Cystaran
Brand Names: Canada
  • Cystadrops
Pharmacologic Category
  • Anticystine Agent;
  • Ophthalmic Agent
Dosing: Adult
Ocular cystinosis

Ocular cystinosis: Ophthalmic:

Solution 0.37%: Instill 1 drop in each eye 4 times/day while awake.

Solution 0.44%: Instill 1 drop in each eye every hour while awake.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Cysteamine (ophthalmic): Pediatric drug information")

Ocular cystinosis

Ocular cystinosis: Children and Adolescents: Ophthalmic:

Solution: 0.37% (eg, Cystadrops): Instill 1 drop in each eye 4 times/day while awake.

Solution: 0.44% (eg, Cystaran): Instill 1 drop in each eye every waking hour.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Nervous system: Headache

Ophthalmic: Blurred vision, deposits on or around the surface of the eye, eye discomfort (instillation site), eye irritation, eye pain, eye pruritus, eye redness, increased lacrimation, ocular hyperemia, photophobia, visual field defect

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to cysteamine or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Intracranial hypertension/papilledema: Intracranial hypertension (pseudotumor cerebri) and/or papilledema have been reported with oral cysteamine treatment; may be managed with diuretics. Cases have also been reported with ophthalmic use, although patients were also on concurrent oral cysteamine.

Special populations:

• Contact lens wearers: Solution contains benzalkonium chloride which may be absorbed by soft contact lenses; contact lenses should be removed prior to use and may be reinserted 15 minutes after administration.

Other warnings/precautions:

• Ophthalmic use: Solution is for topical ophthalmic use only. To avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Cystaran: 0.44% (15 mL) [contains benzalkonium chloride]

Solution, Ophthalmic, as hydrochloride:

Cystadrops: 0.37% (5 mL) [contains benzalkonium chloride, disodium edta]

Generic Equivalent Available: US

No

Pricing: US

Solution (Cystadrops Ophthalmic)

0.37% (per mL): $491.25

Solution (Cystaran Ophthalmic)

0.44% (per mL): $173.79

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic, as hydrochloride:

Cystadrops: 0.37% (5 mL) [contains benzalkonium chloride, disodium edta]

Administration: Adult

Ophthalmic: For topical ophthalmic use only. Wash hands prior to use; to avoid contamination, do not touch dropper eyelids or other surfaces when placing drops in eyes. Separate administration of other ophthalmic agents by at least 10 minutes; administer eye ointments last. Contact lenses should be removed prior to administration and may be reinserted 15 minutes after administration.

Administration: Pediatric

Ophthalmic: For topical ophthalmic use only. Wash hands prior to use; to avoid contamination, do not touch dropper to eyelids or other surfaces when placing drops in eyes. Contact lenses should be removed prior to administration and may be reinserted 15 minutes after administration.

Cystadrops 0.37% solution: Separate the administration of other topically applied ophthalmic medications by at least 10 minutes; administer any ophthalmic ointments last. Discard bottle 7 days after opening, even if product is left in container. Do not rerefrigerate.

Cystaran 0.44% solution: Discard bottle 7 days after thawing, even if product is left in container.

Missed doses: Administer as soon as feasible and continue with next scheduled dose.

Use: Labeled Indications

Ocular cystinosis: Treatment of corneal cystine crystal accumulation in patients with cystinosis

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic exposure is expected to be negligible following ophthalmic administration.

Breastfeeding Considerations

It is unknown whether cysteamine is present in breast milk.

However, systemic exposure is expected to be negligible following ophthalmic administration.

Monitoring Parameters

Ophthalmic examination (periodic).

Mechanism of Action

Reacts with cystine within the lysosome to convert it to cysteine and to a cysteine-cysteamine mixed disulfide, both of which can then exit the lysosome to reduce corneal cystine crystal accumulation in patients with cystinosis, an inherited defect of lysosomal transport

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic exposure is expected to be negligible following ophthalmic administration

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Cystadrops;
  • (AT) Austria: Cystadrops;
  • (AU) Australia: Cysteamine;
  • (BE) Belgium: Cystadrops;
  • (CO) Colombia: Cystadrops;
  • (CZ) Czech Republic: Cystadrops;
  • (DE) Germany: Cystadrops;
  • (FI) Finland: Cystadrops;
  • (FR) France: Cystadrops;
  • (GB) United Kingdom: Cystadrops;
  • (HU) Hungary: Cystadrops;
  • (IT) Italy: Cystadrops;
  • (LT) Lithuania: Cystadrops;
  • (LU) Luxembourg: Cystadrops;
  • (MX) Mexico: Cystadrops;
  • (NL) Netherlands: Cystadrops;
  • (NO) Norway: Cystadrops | Cysteamin;
  • (PL) Poland: Cystadrops;
  • (PR) Puerto Rico: Cystadrops | Cystaran;
  • (PT) Portugal: Cystadrops;
  • (RU) Russian Federation: Cystadrops | Cysteamin;
  • (SA) Saudi Arabia: Cystadrops;
  • (SE) Sweden: Cystadrops;
  • (SK) Slovakia: Cystadrops;
  • (TN) Tunisia: Cystadrops
  1. Cystadrops (cysteamine [ophthalmic]) 0.37% [prescribing information]. Lebanon, NJ: Recordati Rare Diseases Inc; August 2020.
  2. Cystadrops (cysteamine [ophthalmic]) [product monograph]. Oakville, Ontario, Canada: Recordati Rare Diseases Canada Inc; February 2019.
  3. Cystaran (cysteamine) [prescribing information]. Gaithersburg, MD: Leadiant Biosciences Inc; February 2022.
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