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cysteamine hydrochloride

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Overview

What is CYSTARAN?

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: CHNS HClMolecular 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.



What does CYSTARAN look like?



What are the available doses of CYSTARAN?

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

What should I talk to my health care provider before I take CYSTARAN?

How should I use CYSTARAN?

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

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.


What interacts with CYSTARAN?

Sorry No Records found


What are the warnings of CYSTARAN?

Sorry No Records found


What are the precautions of CYSTARAN?

Sorry No Records found


What are the side effects of CYSTARAN?

Sorry No records found


What should I look out for while using CYSTARAN?

None.


What might happen if I take too much CYSTARAN?

Sorry No Records found


How should I store and handle CYSTARAN?

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 54482-020-01CYSTARAN (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 54482-020-01CYSTARAN (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


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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

Non-Clinical Toxicology
None.

Other sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol.

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated.

Beta-receptor blocking agents and albuterol inhibit the effect of each other.

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.

Clinical Studies 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 occuring in ≥10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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