Cystaran

What is Cystaran

• Cystaran (cysteamine hydrochloride) is a cystine-depleting agent used for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Cysteamine

Cysteamine-3D-balls

Cysteamine 3D spacefill

What are the uses of this medicine?

• CYSTARAN is a cystine-depleting agent used for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

How does this medicine work?

• Cysteamine acts as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with CYSTARAN.

Is this medicine FDA approved?

• Initial U.S. Approval: 1994

How should this medicine be used?

Recommended dosage:

• Instill one drop of CYSTARAN in each eye, every waking hour.

Administration:

• Do not touch dropper tip to any surface, as this may contaminate the solution.
• Discard after 1 week of use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride equivalent to 4.4 mg/mL of cysteamine (0.44%).

This medicine is available in fallowing brand namesː

• CYSTARAN

What side effects can this medication cause?

The most common side effects of this medicine include:

• sensitivity to light
• redness
• eye pain/irritation
• headache
• visual field defects

What special precautions should I follow?

• To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.
• 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.
• 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.
• CYSTARAN is for topical ophthalmic use.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks.

Can this medicine be used in children?

• The safety and effectiveness of CYSTARAN (cysteamine ophthalmic solution) 0.44% have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CYSTEAMINE HYDROCHLORIDE

Inactive ingredients:

• BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
• SODIUM CHLORIDE (UNII: 451W47IQ8X)
• HYDROCHLORIC ACID (UNII: QTT17582CB)
• SODIUM HYDROXIDE (UNII: 55X04QC32I)
• WATER

Who manufactures and distributes this medicine?

• Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY for Leadiant Biosciences,

Inc., Gaithersburg, MD.

What should I know about storage and disposal of this medication?

• Store in freezer at -25°C to -15°C (-13°F to 5°F) in the original carton.
• Thaw 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 the thawed medication.
• Discard after 1 week of use.

• Dailymed label info on Cystaran
• FDA Cystaran

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