Cystaran (Cysteamine Ophthalmic Solution) – Cystinosis | HongKong DengYue Medicine

  • Generic Name/Brand Name: ​Cysteamine Ophthalmic Solution / Cystaran®
  • Indications: Cystinosis
  • Dosage Form: ​Ophthalmic solution
  • Specification: 0.44% × 15 mL/dropper bottle

Cysteamine Ophthalmic Solution Application Scope

Cystaran is a topical ophthalmic preparation of cysteamine, which reduces corneal cystine crystal accumulation by breaking disulfide bonds in cystine, forming soluble cysteine-cysteamine mixed disulfides that can exit the lysosome.

Indications:

  • Ocular cystinosis (corneal cystine crystal accumulation): Indicated for treatment of corneal cystine crystal deposits in patients with cystinosis.

cystaran cysteamine ophthalmic solution
cystaran cysteamine ophthalmic solution

Cysteamine Ophthalmic Solution Characteristics

  • Ingredients: Active ingredient: Cysteamine hydrochloride
    Excipients: benzalkonium chloride, disodium edetate, sodium hydroxide, water for injection, etc.

  • Properties:​ Sterile, clear ophthalmic solution.

  • Packaging Specification:​ 0.44% solution in 15 mL dropper bottles.

  • Storage:​ Store in freezer at −25°C to −15°C before dispensing. After dispensing, store in refrigerator (2–8°C). Discard 1 week after opening.

  • Expiry Date: As indicated on package.

  • Executive Standard: ​FDA/EMA approved ophthalmic solution standard.

  • Approval Number: Per local regulatory agency.

  • Date of Revision: As indicated in insert.

  • Manufacturer: Sigma-Tau Pharmaceuticals, Inc. (Leadiant Biosciences).

Guidelines for the Use of Cystaran

  • Dosage and Administration:

    • Recommended Dose: 1 drop in each eye, every waking hour.

    • Administration: Ophthalmic use only. Do not ingest. Instill directly into the conjunctival sac.

    • Missed Dose:​ Instill as soon as remembered; if close to next scheduled dose, continue with regular dosing.

  • Adverse Reactions:

    • Common Adverse Reactions:

      • Ocular burning, stinging

      • Eye redness, irritation

      • Blurred vision

      • Photophobia, eye pain

    • Serious Adverse Reactions:

      • Corneal ulceration (rare)

      • Severe hypersensitivity reactions

  • Contraindications: Hypersensitivity to cysteamine or formulation excipients.

  • Precautions:

    • Strictly ophthalmic use only.

    • Use with caution in patients with ocular surface disease.

    • Must be kept refrigerated; discard after 1 week once opened.

Cysteamine Ophthalmic Solution Interactions

  • No major systemic drug interactions (topical use).

  • Avoid concurrent use with other ophthalmic preparations unless directed by physician.

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  •  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.
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