cysteamine ophthalmic (Rx)

Brand and Other Names:Cystaran, Cystadrops
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.44% (Cystaran)
  • 0.37% (Cystadrops)

Corneal Cystine Crystals

Cystine-depleting agent indicated for corneal cystine crystal accumulation in patients with cystinosis

Cystaran: Instill 1 drop in each eye, every waking hour (ie, q1hr while awake)

Cystadrops: Instill 1 drop in each eye, QID during waking hours

Dosage Modifications

Renal impairment

  • Not evaluated

Dosage Forms & Strengths

ophthalmic solution

  • 0.44% (Cystaran)
  • 0.37% (Cystadrops)

Corneal Cystine Crystals

Cystine-depleting agent indicated for corneal cystine crystal accumulation in patients with cystinosis

Cystaran: Instill 1 drop in each eye, every waking hour (ie, q1hr while awake)

Cystadrops: Instill 1 drop in each eye, QID during waking hours

Dosage Modifications

Renal impairment

Not evaluated

Next:

Adverse Effects

>10%

Cystaran

  • Sensitivity to light
  • Redness
  • Eye pain/irritation
  • Headache
  • Visual field defects

Cystadrops

  • Eye pain
  • Vision blurred
  • Eye irritation
  • Ocular hyperemia
  • Instillation site discomfort
  • Eye pruritus
  • Lacrimation increased
  • Ocular deposits
Previous
Next:

Warnings

Contraindications

None

Cautions

For topical ophthalmic use only

Avoid touching eyelids or surrounding areas with the dropper tip of the bottle to avoid contamination

Benign intracranial hypertension (pseudotumor cerebri) reported with cysteamine PO; there have also been reports associated with cysteamine ophthalmic, however, all of these patients were on concurrent cysteamine PO

Contains benzalkonium chloride, which may be absorbed by soft contact lenses; contact lenses should be removed prior to application and may be reinserted after 15 minutes

Previous
Next:

Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies of ophthalmic cysteamine in pregnant females to inform any drug associated risks

Animal data

  • Oral administration of cysteamine to pregnant rats throughout organogenesis was teratogenic at doses 240 to 960 times the recommended human ophthalmic dose (based on body surface area)
  • Use during pregnancy only if potential benefit justifies potential risk to the fetus

Lactation

No information available regarding presence of cysteamine in human milk, the effects on the breastfed infants, or the effects on milk production

Cysteamine administered orally is present in milk of lactating rats

Unknown whether measurable levels of cysteamine would be present in maternal milk following topical ocular administration

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Acts as a cystine–depleting agent by converting cystine to cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation

Absorption

Negligible; incremental increase in systemic cysteamine levels derived from cysteamine ophthalmic applied topically to the eye in patients treated with oral cysteamine was observed to be negligible

Previous
Next:

Administration

Ophthalmic Preparation

Wash hands carefully in order to avoid microbiological contamination

Do not touch opening of bottle or dropper

Cystaran

  • Each week, remove one new bottle from the freezer
  • Allow bottle to thaw completely (~24 hr) before use

Cystadrops

  • Remove from refrigerator
  • Remove green protective cap, metal seal, and gray stopper from the bottle
  • Advise not to lose the small white cap that comes on the top of the dropper; keep the small white cap tightly closed when not in use

Ophthalmic Administration

Topical ophthalmic use only

Tilt head back

Pull down lower eyelid with a clean finger and look up; allow drop to go into the space between lower eyelid and eye

Do not touch dropper tip to the eyelids, surrounding areas, or any surface, as this may contaminate solution

Concomitant use with topical ocular products

  • Allow an interval of 10 minutes between successive applications
  • Administer eye ointments last

Contact lenses

  • Remove before using drops
  • Wait at least 15 minutes after using drops, before reinserting contact lenses back in eyes

Missed dose

  • Administer a dose as soon as feasible and then continue treatment with next scheduled instillation

Storage

Cystadrops

  • Unopened bottle: Refrigerate at 2-8ºC (36-46ºF) in the original carton
  • Opened bottle: After first opening, store at room temperature at 20-25ºC (68-77ºF) for up to 7 days; do not refrigerate; discard after 7 days of use

Cystaran

  • Unopened: Store in freezer at -25 to -15ºC (-13 to 5ºF) in the original carton
  • Thawed bottle: Store at 2-25ºC (36-77ºF) for up to 7 days; do not refreeze; discard after 7 days of use
Previous
Next:

Images

No images available for this drug.
Previous
Next:

Patient Handout

A Patient Handout is not currently available for this monograph.
Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.