Cysteamine hydrochloride (monograph): Uses, Side Effects & Warnings
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Generic name: cystaran
Pregnancy & Lactation: Risk data available
What is Cysteamine hydrochloride (monograph)?
Introduction
Cystine-depleting agent; an aminothiol.
Uses for Cysteamine Hydrochloride
Corneal Cystine Crystal Accumulation
Treatment of corneal cystine crystal accumulation in patients with cystinosis (designated an orphan drug by FDA for this use).
Because oral cysteamine does not reverse corneal cystine crystal accumulation in cystinosis patients, concurrent ophthalmic cysteamine is necessary.
Temporarily reduces formation of corneal cystine crystals in patients with cystinosis; strict compliance and continued use are necessary for sustained efficacy.
Commercially available in US as a 0.44% (of cysteamine) ophthalmic solution that contains the preservative benzalkonium chloride (Cystaran). Various other ophthalmic formulations (e.g., 0.11%, 0.55%, preservative-free) were studied during the clinical trial program in the US.
Cysteamine Hydrochloride Dosage and Administration
General
Available only through a specialty pharmacy. Call the Cystaran Hotline at 800-440-0473 or visit [Web] for specific information.
Administration
Ophthalmic Administration
Apply topically to each eye as an ophthalmic solution; the solution is for topical ophthalmic use only.
To minimize risk of contamination, avoid touching the eyelids, surrounding areas of the eye, or any other surface with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. (See Advice to Patients.)
Remove contact lenses prior to each dose (since the benzalkonium chloride preservative may be absorbed by soft lenses); may reinsert lenses 15 minutes following administration.
For proper storage information, see Storage under Stability and also see Advice to Patients.
Dosage
Available as cysteamine hydrochloride; dosage is expressed in terms of cysteamine.
Each 6.5 mg of cysteamine hydrochloride is equivalent to 4.4 mg of cysteamine.
Pediatric Patients
Corneal Cystine Crystal Accumulation
Ophthalmic
1 drop of a 0.44% solution in each eye every waking hour.
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.
Adults
Corneal Cystine Crystal Accumulation
Ophthalmic
1 drop of a 0.44% solution in each eye every waking hour.
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.
Special Populations
No special population dosage recommendations at this time. (See Renal Impairment under Cautions.)
Warnings
Contraindications
-
Manufacturer states none known.
Warnings/Precautions
Benign Intracranial Hypertension
Benign intracranial hypertension (or pseudotumor cerebri) and/or papilledema reported with oral cysteamine bitartrate therapy. Benign intracranial hypertension also reported with ophthalmic cysteamine, but all patients were concurrently receiving oral cysteamine therapy.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether oral cysteamine is distributed into human milk. Systemic exposure expected to be negligible following ophthalmic administration. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy established in pediatric patients; the drug is approved for use in such patients. The majority of patients in the ophthalmic cysteamine clinical trials were pediatric patients.
Geriatric Use
Not evaluated; the reduced life expectancy from cystinosis did not allow for inclusion of geriatric patients in the clinical study population.
Renal Impairment
Effect of renal impairment on the pharmacokinetics of cysteamine following ophthalmic administration not evaluated because ophthalmic exposure is negligible compared with systemic exposure. However, the majority of patients in the ophthalmic clinical studies were assumed to have had some degree of renal impairment due to their underlying disease. (See Special Populations under Dosage and Administration.)
Common Adverse Effects
Photophobia (sensitivity to light), ocular (including conjunctival) redness, ocular pain and/or irritation, headache, visual field defects.
Before Taking
How should I use Cysteamine hydrochloride (monograph)
General
Available only through a specialty pharmacy. Call the Cystaran Hotline at 800-440-0473 or visit [Web] for specific information.
Administration
Ophthalmic Administration
Apply topically to each eye as an ophthalmic solution; the solution is for topical ophthalmic use only.
To minimize risk of contamination, avoid touching the eyelids, surrounding areas of the eye, or any other surface with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. (See Advice to Patients.)
Remove contact lenses prior to each dose (since the benzalkonium chloride preservative may be absorbed by soft lenses); may reinsert lenses 15 minutes following administration.
For proper storage information, see Storage under Stability and also see Advice to Patients.
Dosage
Available as cysteamine hydrochloride; dosage is expressed in terms of cysteamine.
Each 6.5 mg of cysteamine hydrochloride is equivalent to 4.4 mg of cysteamine.
Pediatric Patients
Corneal Cystine Crystal Accumulation
Ophthalmic
1 drop of a 0.44% solution in each eye every waking hour.
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.
Adults
Corneal Cystine Crystal Accumulation
Ophthalmic
1 drop of a 0.44% solution in each eye every waking hour.
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.
Special Populations
No special population dosage recommendations at this time. (See Renal Impairment under Cautions.)
What happens if I miss a dose?
What happens if I overdose?
What should I avoid while using Cysteamine hydrochloride (monograph)?
Cysteamine hydrochloride (monograph) side effects
What other drugs will affect Cysteamine hydrochloride (monograph)?
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