April 28, 2017
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Cystaran

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Cystaran

Indications
Dosage
How Supplied

INDICATIONS

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

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.

HOW SUPPLIED

Dosage Forms And Strengths

Sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride equivalent to 4.4 mg/mL of cysteamine (0.44%).

Storage And Handling

CYSTARAN (cysteamine ophthalmic solution) 0.44% is supplied in a 15 mL, opaque, white, low-density polyethylene (LDPE) bottle with a 15 mm white, LDPE controlled dropper tip and closed with a white, polypropylene screw cap.

Storage

Store in freezer at -25°C to -15°C (-13°F to 5°F). 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. Discard after 1 week of use.

NDC 54482-020-01

Manufactured by: Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701 for sigma-tau, Pharmaceuticals, Inc, Gaithersburg, MD 20878. Revised: 10/2012

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/3/2017

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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