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. Cystaran belongs to a class of medications called anti-cystine agents, which help by decreasing the levels of cystine in the body.

This medication comes as an eye drop that is used once every waking hour.

The most common side effects with Cystaran include sensitivity to light, redness, eye pain/irritation, headache and visual field defects. Do not drive or operate heavy machinery until you know how this medication will affect you.

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.

• Sigma-Tau Pharmaceuticals, Inc.

Serious side effects have been reported with Cystaran. See the "Cystaran Precautions" section. 

Common side effects of Cystaran include the following:

• sensitivity to light
• redness
• eye pain/irritation
• headache
• visual field defects 

Do not drive or operate heavy machinery until you know how this medication will affect you.

This is not a complete list of Cystaran side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with Cystaran including the following:

• Risk of contamination. To avoid contamination, do not to touch the eyelid or surrounding areas with the dropper tip of the bottle. The cap should remain on the bottle when not in use.
• Cystaran contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
• Benign Intracranial hypertension (pseudotumor cerebri) has happened in some people who take immediate-release cysteamine. There have also been reports associated with ophthalmic use of cysteamine; however, all of these patients were on concurrent oral cysteamine. This is a condition where there is high pressure in the fluid around the brain. Your doctor should do eye examinations to find and treat this problem early. Tell your doctor right away if you develop any of the following symptoms while taking cysteamine: headache, buzzing or "whooshing" sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye, or pain with eye movement. 

Do not take Cystaran if you are allergic to Cystaran or any of its ingredients. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cystaran, there are no specific foods that you must exclude from your diet when receiving Cystaran.

Before taking Cystaran, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cystaran or any of its ingredients
• wear contact lenses

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cystaran falls into category C. There are no adequate and well-controlled studies in pregnant women. It is not known if Cystaran will harm your unborn baby. Cystaran should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Talk with your doctor about the benefits and risks of using Cystaran during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if the oral formulation of this drug 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.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the state of the condition being treated
• how you respond to this medication

The recommended usage of Cystaran to treat cystinosis of the eyes is one drop applied to each eye, every waking hour. 

If you use too much Cystaran call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store bottles in the freezer at in the original carton.
• Each week, one new bottle should be removed from the freezer.
• Allow the bottle to thaw completely (approximately 24 hours) prior to use.
• After the bottle is completely thawed, record the discard date on the bottle label. The discard date is seven (7) days from the day the bottle is thawed.
• Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. The thawed bottles should not be refrozen.
• At the end of 1 week (7 days), discard the bottle. There may be medication left in the bottle; however, the bottle must be discarded because the medication is only stable for 1 week after thawing.