Cystadrops

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 stopper (see Figure C ) from the bottle.
• Do not touch the opening of the bottle after removing the gray stopper.
• Take the dropper out of its packaging, without touching the end intended to be attached to the bottle, attach it (see Figure D ) to the bottle and do not remove it.
• Patients should be advised not to lose the small white cap that comes on the top of the dropper (see Figure E ).
• Keep the small white cap tightly closed when not in use.
• Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours.
• At the end of 7 days, patients should discard the bottle.
• There may be medication left in the bottle; however, the bottle must be discarded by the patient because the medication is only stable for 7 days after first opening.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of CYSTADROPS has been established in pediatric patients. Use of CYSTADROPS is supported by adequate and well controlled trials in pediatric patients and additional experience supporting the safety of CYSTADROPS.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of CYSTADROPS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
• Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
• Preparation for Administration and Storage of Bottles Advise patients to store new unopened bottles in the refrigerator in the original carton.
• Each week, one new bottle should be removed from the refrigerator.
• Advise patients to write the date the bottle was opened in the space on the carton.
• After first opening, keep the bottle tightly closed and
• store at room temperature in the original carton.
• 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 stopper (see Figure C) from the bottle.
• Do not touch the opening of the bottle after removing the gray stopper.
• Take the dropper out of its packaging, without touching the end intended to be attached to the bottle, attach it (see Figure D) to the bottle and do not remove it.
• Patients should be advised not to lose the small white cap (see Figure E) that comes on the top of the dropper.
• Keep the small white cap tightly closed when not in use.
• Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours.
• Instruct patients to discard the bottle at the end of 7 days.
• There may be medication left in the bottle; however, the bottle must be discarded by the patient because the medication is only stable for 7 days after first opening.
• Risk of Contamination Advise patients not to touch the eyelid or surrounding areas with the dropper tip of the bottle.
• The cap should remain on the bottle when not in use.
• Contact Lens Use Advise patients that contact lenses should be removed prior to application of CYSTADROPS.
• Contact lenses may be reinserted 15 minutes following CYSTADROPS administration [see Warnings and Precautions ( 5.3 )] .
• Topical Ophthalmic Use Advise patients that CYSTADROPS is for topical ophthalmic use.
• Missed Dose If the patient misses an instillation, instruct the patient to administer a dose as soon as feasible and then to continue the treatment with the next scheduled instillation.
• Manufactured by:
• Baccinex SA, 2822 Courroux, Switzerland Manufactured for:
• Recordati Rare Diseases Inc., Bridgewater, NJ 08807, U.S.A.
• This product label may have been updated.
• For the most recent prescribing information, please visit www.recordatirarediseases.com/us.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ophthalmic solution containing 3.8 mg/mL of cysteamine (0.37%). Ophthalmic solution containing 3.8 mg/mL of cysteamine (0.37%). ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• CYSTADROPS (cysteamine ophthalmic solution) 0.37% is supplied as a 5 mL sterile viscous solution in a 10 mL amber glass bottle closed by a bromobutyl stopper and sealed with an aluminum tear-off cap.
• A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.
• Each carton box (NDC 55292-410-05) contains 1 bottle (NDC 55292-410-05) and 1 dropper applicator individually wrapped.
• Before First Opening :
• Before opening, store new, unopened CYSTADROPS in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep the bottle in the outer carton in order to protect from light.
• After First Opening :
• After opening, store opened CYSTADROPS at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not refrigerate after opening.
• Keep the dropper bottle tightly closed in the outer carton in order to protect from light.
• Discard 7 days after first opening.

Quoted from the official label, section “How Supplied”.

What is in it

• 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.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Cysteamine Hydrochloride