cystaran
Cystaran (Cysteamine Hydrochloride) is a cystine depleting agent used to treat Cystinosis.
Cysteamine Hydrochloride · by Leadiant Biosci Inc
Key facts
- Active ingredient
- Cysteamine Hydrochloride
- Drug class
- Cystine Depleting Agent
- Form
- Solution
- Strength
- Cysteamine Hydrochloride EQ 0.44% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cystinosis
- Manufacturer
- Leadiant Biosci Inc
- FDA application
- NDA200740
What is Cystaran?
From the FDA label: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
How to use
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 )
Side effects
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.
Warnings
Important safety information
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.
Who should not take Cystaran
None. None. ( 4 )
Drug class
May treat (source: NIH RxClass)
See how Cystaran ranks — best-rated cystine depleting agent for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cystaran treat?
- Cystaran (Cysteamine Hydrochloride) may be used to treat cystinosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Cystaran?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cystaran. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cystaran?
- Cystaran is marketed by Leadiant Biosci Inc. You can see Leadiant Biosci Inc's full profile, rating, and other products on pharmaranks.
- Is Cystaran a brand-name or generic drug?
- Cystaran is a brand-name product with the active ingredient Cysteamine Hydrochloride.
- Is Cystaran available over the counter?
- No. Cystaran is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cystaran come in?
- Cystaran is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Cystaran?
- Cystaran is classified as cystine depleting agent, per the FDA's Established Pharmacologic Class.
- Is Cystaran FDA-registered?
- Cystaran is on record with the U.S. FDA under application number NDA200740. You can verify this on its official FDA label.
- Is Cystaran safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cystaran. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cystaran?
- Cystaran's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
Compare Cystaran head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
cystaran
New