Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Fifteen (15) mL of CYSTARAN (cysteamine ophthalmic solution) 0.44% is supplied in an opaque, white, low-density polyethylene (LDPE) 88 mm tall bottle with a 1.6 mm blue, silicone rubber flow-controlled dropper tip and closed with a white, high-density polyethylene (HDPE) screw cap. The bottle is foil-wrapped and stored in a carton. CYSTARAN bottles must be stored in the following conditions: NDC 54482- 020 -02 Before Opening: Store unopened bottle in freezer at -25°C to -15°C (-13°F to 5°F) in the original packaging including unopened foil. Thaw for approximately 24 hours before use. Open the carton and the foil only when starting a new bottle. After Opening: Record discard date on the bottle, which is 1 week from the day the foil and bottle were opened. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. The thawed bottle does not require refrigeration between use. Do not refreeze the thawed medication. Discard 1 week after the foil and bottle were opened even if there is medication left in the bottle. NDC 54482- 035 -02 Before Opening: Store unopened bottle in refrigerator at 2°C to 8°C (36°F to 46°F) in the original packaging including unopened foil. Open the carton and the foil only when starting a new bottle. After Opening: Record discard date on the bottle, which is 1 week from the day the foil and bottle were opened. During the week of use, store bottle at room temperature, 20°C to 25°C (68°F to 77°F). Discard 1 week after the foil and bottle were opened even if there is medication left in the bottle.; PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton NDC 54482- 020 -02 cystaran ® (cysteamine ophthalmic solution) 0.44% For Topical Ophthalmic Use Sterile 15 mL Rx only Active Ingredient: Each mL contains 6.5 mg cysteamine hydrochloride, equivalent to 4.4 mg cysteamine. Inactive Ingredients: Benzalkonium chloride (preservative); Sodium chloride; hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. Dosage: See Prescribing Information. Storage: Store in freezer in original carton at -25°C to -15°C (-13°F to 5°F). Thaw in original carton for approximately 24 hours before use. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. Do not refreeze thawed medication. Discard after 1 week of use, even if there is remaining drug product. Avoid touching dropper tip to any surface. For Topical Ophthalmic Use cysc-6-m Distributed by: Leadiant Biosciences Inc., Rockville, MD 20850 Made in Switzerland PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton; PRINCIPAL DISPLAY PANEL - Carton NDC 54482- 035 -02 cystaran ® (cysteamine ophthalmic solution) 0.44% For Topical Ophthalmic Use Sterile NEW STORAGE Rx only 15 mL Active Ingredient: Each mL contains 6.5 mg cysteamine hydrochloride, equivalent to 4.4 mg cysteamine. Inactive Ingredients: Benzalko- nium chloride (preservative); Sodium chloride; hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. Dosage: See Prescribing Information. Storage: Before Opening: Store in refrigerator in original packaging, including unopened foil, at 2°C to 8°C (36°F to 46°F). After Opening: After opening the foil, store bottle at room temperature 20°C to 25°C (68°F to 77°F) during week of use. Discard the bottle 1 week after opening the foil and bottle, even if there is remaining medication in the bottle. Avoid touching dropper tip to any surface. cysc-7-m Distributed by: Leadiant Biosciences, Inc. , Rockville, MD 20850 Made in Switzerland PRINCIPAL DISPLAY PANEL - Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Fifteen (15) mL of CYSTARAN (cysteamine ophthalmic solution) 0.44% is supplied in an opaque, white, low-density polyethylene (LDPE) 88 mm tall bottle with a 1.6 mm blue, silicone rubber flow-controlled dropper tip and closed with a white, high-density polyethylene (HDPE) screw cap. The bottle is foil-wrapped and stored in a carton. CYSTARAN bottles must be stored in the following conditions: NDC 54482- 020 -02 Before Opening: Store unopened bottle in freezer at -25°C to -15°C (-13°F to 5°F) in the original packaging including unopened foil. Thaw for approximately 24 hours before use. Open the carton and the foil only when starting a new bottle. After Opening: Record discard date on the bottle, which is 1 week from the day the foil and bottle were opened. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. The thawed bottle does not require refrigeration between use. Do not refreeze the thawed medication. Discard 1 week after the foil and bottle were opened even if there is medication left in the bottle. NDC 54482- 035 -02 Before Opening: Store unopened bottle in refrigerator at 2°C to 8°C (36°F to 46°F) in the original packaging including unopened foil. Open the carton and the foil only when starting a new bottle. After Opening: Record discard date on the bottle, which is 1 week from the day the foil and bottle were opened. During the week of use, store bottle at room temperature, 20°C to 25°C (68°F to 77°F). Discard 1 week after the foil and bottle were opened even if there is medication left in the bottle.
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton NDC 54482- 020 -02 cystaran ® (cysteamine ophthalmic solution) 0.44% For Topical Ophthalmic Use Sterile 15 mL Rx only Active Ingredient: Each mL contains 6.5 mg cysteamine hydrochloride, equivalent to 4.4 mg cysteamine. Inactive Ingredients: Benzalkonium chloride (preservative); Sodium chloride; hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. Dosage: See Prescribing Information. Storage: Store in freezer in original carton at -25°C to -15°C (-13°F to 5°F). Thaw in original carton for approximately 24 hours before use. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. Do not refreeze thawed medication. Discard after 1 week of use, even if there is remaining drug product. Avoid touching dropper tip to any surface. For Topical Ophthalmic Use cysc-6-m Distributed by: Leadiant Biosciences Inc., Rockville, MD 20850 Made in Switzerland PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
- PRINCIPAL DISPLAY PANEL - Carton NDC 54482- 035 -02 cystaran ® (cysteamine ophthalmic solution) 0.44% For Topical Ophthalmic Use Sterile NEW STORAGE Rx only 15 mL Active Ingredient: Each mL contains 6.5 mg cysteamine hydrochloride, equivalent to 4.4 mg cysteamine. Inactive Ingredients: Benzalko- nium chloride (preservative); Sodium chloride; hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. Dosage: See Prescribing Information. Storage: Before Opening: Store in refrigerator in original packaging, including unopened foil, at 2°C to 8°C (36°F to 46°F). After Opening: After opening the foil, store bottle at room temperature 20°C to 25°C (68°F to 77°F) during week of use. Discard the bottle 1 week after opening the foil and bottle, even if there is remaining medication in the bottle. Avoid touching dropper tip to any surface. cysc-7-m Distributed by: Leadiant Biosciences, Inc. , Rockville, MD 20850 Made in Switzerland PRINCIPAL DISPLAY PANEL - Carton
Overview
CYSTARAN is a sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride, equivalent to 4.4 mg/mL of cysteamine (0.44%) as the active ingredient. Cysteamine is a cystine-depleting agent which lowers the cystine content of cells in patients with cystinosis. Molecular Formula: C 2 H 7 NS HCl Molecular Weight: 113.61 Each milliliter of CYSTARAN contains: Active: cysteamine 4.4 mg (equivalent to cysteamine hydrochloride 6.5 mg); Preservative: benzalkonium chloride 0.1 mg; Inactive Ingredients: sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH to 4.1-4.5), and purified water. Chemical Structure
Indications & Usage
CYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. ( 1 )
Dosage & Administration
Instill one drop of CYSTARAN in each eye, every waking hour. Do not touch dropper tip to any surface, as this may contaminate the solution. Discard after 1 week of use. Instill one drop of CYSTARAN in each eye, every waking hour. ( 2 )
Warnings & Precautions
To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) 5.1 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. 5.2 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. 5.3 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) ] . 5.4 Topical Ophthalmic Use CYSTARAN is for topical ophthalmic use.
Contraindications
None. None. ( 4 )
Adverse Reactions
The most common adverse reactions (incidence approximately 10% or greater) are sensitivity to light, redness, eye pain/irritation, headache and visual field defects. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in controlled clinical trials of six months to 19 years duration in approximately 300 patients. The most frequently reported ocular adverse reactions occurring in ≥10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.
Storage & Handling
CYSTARAN bottles must be stored in the following conditions: NDC 54482- 020 -02 Before Opening: Store unopened bottle in freezer at -25°C to -15°C (-13°F to 5°F) in the original packaging including unopened foil. Thaw for approximately 24 hours before use. Open the carton and the foil only when starting a new bottle. After Opening: Record discard date on the bottle, which is 1 week from the day the foil and bottle were opened. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. The thawed bottle does not require refrigeration between use. Do not refreeze the thawed medication. Discard 1 week after the foil and bottle were opened even if there is medication left in the bottle.
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