Cystaran
Name: Cystaran
- Cystaran drug
- Cystaran uses
- Cystaran used to treat
- Cystaran cystaran dosage
- Cystaran mg
- Cystaran dosage
- Cystaran average dose
- Cystaran missed dose
- Cystaran side effects
- Cystaran adverse effects
- Cystaran effects of
Cystaran Interactions
Do not use this medicine while wearing contact lenses. Cysteamine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.
It is not likely that other drugs you take orally or inject will have an effect on cysteamine used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.
Uses of Cystaran
Cystaran is a prescription medication used to treat cystinosis of the eyes. Cystinosis is a rare condition that causes cystine, a protein building block, to build up in the cells of the body.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Cystaran and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if oral cysteamine (the active ingredient found in Cystaran) is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Cystaran, you should not breastfeed during treatment with Cystaran. Talk with your doctor about the best way to feed your baby if you use Cystaran.
Cystaran Usage
Use Cystaran exactly as your doctor tells you to.
- Instill one drop of Cystaran eye drop solution in each eye, every waking hour.
- Contact lenses should be removed prior to application of Cystaran eye drops. Contact lenses may be reinserted 15 minutes following use.
- Do not touch dropper tip to any surface, as this may contaminate the solution.
- Allow the bottle to thaw completely (approximately 24 hours) prior to use.
- Discard bottle after 1 week of use.
Side effects
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 occurring in ≥ 10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.
Read the entire FDA prescribing information for Cystaran (Cysteamine Ophthalmic Solution)
Read More »What should I avoid while using cysteamine ophthalmic?
Do not use this medicine while wearing contact lenses. Cysteamine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.
Cystaran Dosage and Administration
General
Available only through a specialty pharmacy.12 Call the Cystaran Hotline at 800-440-0473 or visit for specific information.12
Administration
Ophthalmic Administration
Apply topically to each eye as an ophthalmic solution; the solution is for topical ophthalmic use only.1
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.1 Keep the bottle tightly closed when not in use.1 (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.1
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.1
Each 6.5 mg of cysteamine hydrochloride is equivalent to 4.4 mg of cysteamine.1
Pediatric Patients
Corneal Cystine Crystal Accumulation Ophthalmic1 drop of a 0.44% solution in each eye every waking hour.1
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.1
Adults
Corneal Cystine Crystal Accumulation Ophthalmic1 drop of a 0.44% solution in each eye every waking hour.1
Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.1
Special Populations
No special population dosage recommendations at this time.1 (See Renal Impairment under Cautions.)
Advice to Patients
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Importance of advising patients and caregivers on proper storage of bottles containing cysteamine hydrochloride ophthalmic solution.1 Initially, store bottles in the freezer in their original carton; each week, remove one new bottle from the freezer and allow it to thaw completely (for approximately 24 hours) before use.1 After completely thawed, store bottle at 2–25°C (36–77°F); do not refreeze.1 Importance of noting the date the bottle was completely thawed in the space provided on the label and discarding bottle 1 week (7 days) after that date.1 (See Storage under Stability.)
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To minimize the risk of contamination of the dropper tip and solution, take care not to touch the eyelids or surrounding areas or any other surface with the dropper tip of the bottle.1 Importance of keeping the bottle tightly closed when not in use.1
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Importance of removing contact lenses prior to administration of each dose, since the benzalkonium chloride preservative may be absorbed by soft lenses.1 May reinsert lenses at least 15 minutes after cysteamine instillation.1
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Importance of advising patients that cysteamine hydrochloride ophthalmic solution is for ophthalmic use only.1
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Importance of continued adherence to therapy since cystine crystals accumulate if use of cysteamine ophthalmic solution is discontinued.1 6
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Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
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Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
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Importance of informing patients of other important precautionary information.1 (See Cautions.)
Proper Use of Cystaran
Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
If you or your child are wearing contact lenses, remove them before you use cysteamine eye drops. Wait for at least 15 minutes before putting the contact lenses back in. Talk to your eye doctor about this if you have questions.
To use the eye drops:
- First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
- Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic dosage form (eye drops):
- For cystine crystal buildup in the cornea:
- Adults—Use one drop in each eye, every waking hour.
- Children—Use one drop in each eye, every waking hour.
- For cystine crystal buildup in the cornea:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the bottle in its original carton in the freezer. Allow the bottle to reach room temperature before use. You may store the thawed bottle in the refrigerator or at room temperature; do not refreeze. Throw away any unused medicine after 7 days.
How is this medicine (Cystaran) best taken?
Use Cystaran as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- For the eye only.
- Take out contact lenses before using this medicine. Lenses may be put back in 15 minutes after Cystaran is given. Do not put contacts back in if your eyes are irritated or infected.
- Do not touch the container tip to the eye, lid, or other skin.
- Tilt your head back and drop drug into the eye.
- After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
What do I do if I miss a dose?
- Use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Change in eyesight, eye pain, or very bad eye irritation.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Cystaran or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cystaran. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: October 4, 2017
Clinical Studies
Clinical efficacy was evaluated in controlled clinical trials in approximately 300 patients. The primary efficacy end point was the response rate of eyes that had a reduction of at least 1 unit in the photo-rated Corneal Cystine Crystal Score (CCCS) at some time point during the study when baseline CCCS ≥1, or a lack of an increase of more than 1 unit in CCCS throughout the study when baseline CCCS <1.
Study 1 combined the data from three smaller studies. For eyes with a lower baseline of CCCS <1, the response rate was 13% (4/30) [95% CI: (4, 32)]. For eyes with a higher baseline of CCCS ≥1, the response rate was 32% (94/291) [95% CI: (27, 38)].
Study 2 evaluated ocular cystinosis patients who had a baseline of CCCS ≥1. The response rate was 67% (10/15) [95% CI: (38, 88)].
Study 3 also evaluated ocular cystinosis patients; for eyes with a baseline of CCCS ≥1, the response rate was 33% (3/9) [95% CI: (8, 70)].
Corneal crystals accumulate if Cystaran is discontinued.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
For the Consumer
Applies to cysteamine ophthalmic: ophthalmic solution
Along with its needed effects, cysteamine ophthalmic (the active ingredient contained in Cystaran) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cysteamine ophthalmic:
More common- Blurred vision
- decrease or change in vision
- eye pain
- red, sore eyes
- sensitivity of the eyes to light
Some side effects of cysteamine ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common- Headache