CYSTARAN 6.5 mg/mL
cysteamine hydrochloride · SOLUTION · Leadiant Biosciences, Inc.
CYSTARAN is a solution containing cysteamine hydrochloride at 6.5 mg/mL, taken ophthalmic. Manufactured by Leadiant Biosciences, Inc..
Key Facts
- Brand Name
- CYSTARAN
- Generic Name
- cysteamine hydrochloride
- NDC Code (Product)
54482-020- Manufacturer
- Leadiant Biosciences, Inc.
- Strength
- 6.5 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA200740
- Marketing Start
- 12/30/2012
Recall History
Leadiant Biosciences, Inc.
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
LEADIANT BIOSCIENCES, INC
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
LEADIANT BIOSCIENCES, INC
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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
2 DOSAGE AND 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 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 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.
Frequently Asked Questions
What is CYSTARAN used for?
CYSTARAN contains cysteamine hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is CYSTARAN a controlled substance?
CYSTARAN is not classified as a controlled substance by the DEA.
What is the generic name for CYSTARAN?
The generic name for CYSTARAN is cysteamine hydrochloride. There are 1 other brand versions of cysteamine hydrochloride.
What is the NDC code for CYSTARAN 6.5 mg/mL?
The NDC (National Drug Code) for CYSTARAN 6.5 mg/mL is 54482-020, listed by Leadiant Biosciences, Inc..