cystadrops
Cystadrops (Cysteamine Hydrochloride) is a cystine depleting agent used to treat Cystinosis.
Cysteamine Hydrochloride · by Recordati Rare
Key facts
- Active ingredient
- Cysteamine Hydrochloride
- Drug class
- Cystine Depleting Agent
- Form
- Solution
- Strength
- Cysteamine Hydrochloride EQ 0.37% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cystinosis
- Manufacturer
- Recordati Rare
- FDA application
- NDA211302
What is Cystadrops?
From the FDA label:CYSTADROPS is a sterile, viscous, ophthalmic solution containing 3.8 mg/mL of cysteamine (0.37%) equivalent to 5.6 mg/mL of cysteamine hydrochloride (0.55%). 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 CYSTADROPS contains: Active: cysteamine 3.8 mg (equivalent to cysteamine hydrochloride 5.6 mg); Preservative: benzalkonium chloride 0.1 mg; Inactive Ingredients: carmellose sodium, citric acid monohydrate, disodium edetate dihydrate, hydrochloric acid and sodium hydroxide (to adjust pH to 4.6-5.4), and water for injection.
How to use
Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours. ( 2.1 ) 2.1 Dosage Information Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours. Do not touch dropper tip to the eyelids, surrounding areas, or any surface, as this may contaminate the solution. In case of concomitant therapy with other topical ocular products, an interval of 10 minutes should be allowed between successive applications. Eye ointments should be administered last. If the patient misses an instillation, the patient should be told to administer a dose as soon as feasible and then continue the treatment with the next scheduled instillation. Discard bottle 7 days after first opening. 2.2 Preparation for Administration Patients should be advised to store new unopened CYSTADROPS bottles in the refrigerator in the original carton between 36°F to 46°F (2°C to 8°C). Each week, one new bottle should be removed from the refrigerator. Patients are to write the date the bottle was opened in the space on the carton. After first opening, store opened CYSTADROPS at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate after opening. Patients are to wash their hands carefully in order to avoid microbiological contamination of the content in the bottle. Remove the green protective cap (see Figure A ). Remove the metal seal (see Figure B ). Remove the gray…
Side effects
The most common adverse reactions (≥ 10%) are eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, 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 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 most common adverse reactions (≥ 10%) reported during clinical trials were eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits.
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 CYSTADROPS contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration [see Patient Counseling Information ( 17 )] .
Who should not take Cystadrops
None. None. ( 4 )
Drug class
May treat (source: NIH RxClass)
See how Cystadrops 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
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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.
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Frequently asked questions
- What does Cystadrops treat?
- Cystadrops (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 Cystadrops?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cystadrops. 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 Cystadrops?
- Cystadrops is marketed by Recordati Rare. You can see Recordati Rare's full profile, rating, and other products on pharmaranks.
- Is Cystadrops a brand-name or generic drug?
- Cystadrops is a brand-name product with the active ingredient Cysteamine Hydrochloride.
- Is Cystadrops available over the counter?
- No. Cystadrops 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 Cystadrops come in?
- Cystadrops is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Cystadrops?
- Cystadrops is classified as cystine depleting agent, per the FDA's Established Pharmacologic Class.
- Is Cystadrops FDA-registered?
- Cystadrops is on record with the U.S. FDA under application number NDA211302. You can verify this on its official FDA label.
- Is Cystadrops safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cystadrops. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cystadrops?
- Cystadrops's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (≥ 10%) are eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344,… 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.
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