Atopica

Cyclosporine is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants. Cyclosporine may also be used to treat psoriasis and symptoms of rheumatoid arthritis. Cyclosporine eye drops are prescribed to increase tear production in people with chronic dry eye disease caused by inflammation.

Cyclosporine belongs to a group of drugs called immunosuppressants. They work by decreasing the activity of the immune system.

Cyclosporine comes as a capsule, an oral liquid solution, an intravenous (IV) injection and an eye drop. It is usually taken once or twice a day, depending on the particular product you are using. This medication is available in its original form and in a modified form that has been slightly changed to be more easily absorbed by the body.

Common side effects of cyclosporine oral and injectable include high blood pressure, gum overgrowth, and tremors. Cyclosporine eye drops commonly cause eye burning, itching, stinging or redness.

Cyclosporine is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants.

Cyclosporine (modified) may also be used to treat psoriasis  symptoms of rheumatoid arthritis.

Cyclosporine ophthalmic emulsion is used to increase tear production in patients with chronic dry eye disease caused by inflammation.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Animal Health US, Inc.

Oral/Injectable:

Common side effects of cyclosporine include:

• headache
• diarrhea
• nausea
• vomiting
• kidney dysfunction
• tremor
• hirsutism (excessive growth of hair in women in a male-like pattern)
• high blood pressure
• gum tissue overgrowth

Ophthalmic:

Common side effects of cyclosporine eye drops include:

• burning, itching, stinging, redness
• eye pain
• overflow of tears
• red eyes
• watery eyes or eye discharge
• blurred vision or other vision changes
• feeling that something is in the eye

Tell your doctor if any side effect is bothersome or does not go away. Cyclosporine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

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

• other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf)
• other medicines that can cause high blood pressure or kidney damage such as amphotericin B (Amphotec, Fungizone); cimetidine (Tagamet); ciprofloxacin (Cipro); colchicine; fenofibrate (Antara, Lipophen, Tricor); gemfibrozil (Lopid); gentamicin; ketoconazole (Nizoral); melphalan (Alkeran); nonsteroidal anti-inflammatory drugs such as diclofenac (Cataflam, Voltaren), naproxen (Aleve, Naprosyn), and sulindac (Clinoril); ranitidine (Zantac); tobramycin (Tobi); trimethoprim with sulfamethoxazole (Bactrim, Septra); and vancomycin (Vancocin)
• acyclovir (Zovirax)
• allopurinol (Zyloprim)
• amiodarone (Cordarone)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• certain antifungal medications such as fluconazole (Diflucan), and itraconazole (Sporanox); azithromycin (Zithromax)
• bromocriptine (Parlodel)
• calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), and verapamil (Calan); carbamazepine (Tegretol)
• cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)
• clarithromycin (Biaxin)
• dalfopristin and quinupristin combination (Synercid)
• danazol
• digoxin (Lanoxin)
• certain diuretics ('water pills') including amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyazide)
• erythromycin
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase)
• imatinib (Gleevec)
• metoclopramide (Reglan)
• methylprednisolone (Medrol)
• nafcillin; octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• orlistat (Xenical)
• phenobarbital
• phenytoin (Dilantin)
• potassium supplements
• prednisolone (Pediapred)
• repaglinide (Prandin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• St. John's wort
• sulfinpyrazone (Anturane)
• terbinafine (Lamisil)
• ticlopidine (Ticlid)

This is not a complete list of cyclosporin drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Ophthalmic:

• Cyclosporine eye drops is for ophthalmic (eye) use only.
• Do not use cyclosporine eye drops if you:
  • have a current eye infection
  • are allergic to cyclosporine (brand name Restasis)
  • are wearing contact lenses. Remove contact lenses before instilling Restasis eye drops and wait at least 15 minutes before putting contacts back in. Talk to your doctor about wearing contact lenses if you have dry eye disease.

Grapefruit and grapefruit juice may interact with cyclosporine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Your doctor may tell you to limit the amount of potassium in your diet. Follow these instructions carefully. Talk to your doctor about the amount of potassium-rich foods such as bananas, prunes, raisins, and orange juice you may have in your diet. Many salt substitutes contain potassium, so talk to your doctor about using them during your treatment.

Before using cyclosporine, tell your doctor about all of your medical conditions including:

• if you are allergic to cyclosporine, cyclosporine (modified), any other medications, or any of the inactive ingredients in cyclosporine or cyclosporine (modified) capsules or solution. Ask your pharmacist for a list of the inactive ingredients
• tell your doctor if you have or have ever had any of the conditions mentioned in the "Cyclosporine Precautions" section
• tell your doctor if you have low cholesterol, low levels of magnesium in your blood, any condition that makes it difficult for your body to absorb nutrients, or liver disease
• tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye
• if you are pregnant or breastfeeding

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

Do not have vaccinations without talking to your doctor.

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.

Cyclosporine falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if cyclosporine  is excreted in human breast milk or if it will harm your nursing baby.

Oral:

Cyclosporine and cyclosporine (modified) both come as a capsule and a solution (liquid) to take by mouth. Cyclosporine is usually taken once a day. Cyclosporine (modified) is usually taken twice a day. It is important to take both types of cyclosporine on a regular schedule. Take cyclosporine or cyclosporine (modified) at the same time(s) each day, and allow the same amount of time between doses and meals every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cyclosporine or cyclosporine (modified) exactly as directed. Do not take more or less of the medication or take it more often than prescribed by your doctor.

You may notice an unusual smell when you open a blister card of cyclosporine capsules. This is normal and does not mean that the medication is damaged or unsafe to use.

Cyclosporine (modified) oral solution may gel or become lumpy if it is exposed to temperatures below 68 °F (20 °C). You can use the solution even if it has gelled, or you can turn the solution back to a liquid by allowing it to warm to room temperature (77 °F [25 °C]).

Cyclosporine and cyclosporine (modified) oral solution must be mixed with a liquid before use. Cyclosporine (modified) oral solution may be mixed with orange juice or apple juice but should not be mixed with milk. Cyclosporine oral solution may be mixed with milk, chocolate milk, or orange juice. You should choose one drink from the appropriate list and always mix your medication with that drink.

To take either type of oral solution, follow these steps:

• Fill a glass (not plastic) cup with the drink you have chosen.
• Remove the protective cover from the top of the dosing syringe that came with your medication.
• Place the tip of the syringe into the bottle of solution and pull back on the plunger to fill the syringe with the amount of solution your doctor has prescribed.
• Hold the syringe over the liquid in your glass and press down on the plunger to place the medication in the glass.
• Stir the mixture well.
• Drink all of the liquid in the glass right away.
• Pour a little more of the drink you have chosen into the glass, swirl the glass around to rinse, and drink the liquid.
• Dry the outside of the syringe with a clean towel and replace the protective cover. Do not wash the syringe with water. If you do need to wash the syringe, be sure that it is completely dry before you use it to measure another dose.

Injectable:

• This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
• Cyclosporine injection comes as a solution (liquid) to be injected over 2 to 6 hours into a vein, usually by a health care professional in a hospital or medical facility. It is usually given 4 to 12 hours before transplant surgery and once a day after the surgery until medication can be taken by mouth.
• A health care professional will watch you closely while you are receiving cyclosporine injection so that you can be treated quickly if you have a serious allergic reaction.

Ophthalmic:

• Cyclosporine eye drops are for use only in the eye(s). Do not swallow or apply cyclosporine eye drops to the skin.
• Use cyclosporine eye drops exactly as prescribed. One drop is instilled in each eye twice daily, with doses about 12 hours apart.
• cyclosporine eye drops come in single-use (one dose) vials. The liquid from one vial should be used immediately after opening. Do not save it for later use.
• If you are wearing contact lenses, remove them before instilling cyclosporine eye drops, and wait at least 15 minutes before putting them back in.
• if you are using artificial tears, instill them at least 15 minutes before or after you instill cyclosporine eye drops.

To instill the eye drops, follow these steps:

• Wash your hands thoroughly with soap and water.
• Mix by turning the vial over a few times until the liquid inside looks white and not see-through.
• Open the vial.
• Do not allow the dropper to touch your eye or any other surface.
• Tilt your head back, pull down the lower lid of your eye with your index finger to form a pocket.
• While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
• Close your eye for 2 to 3 minutes and tilt your head down, without blinking or squeezing eyelids.
• Apply gentle pressure on the tear duct with your finger.
• If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
• Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
• Throw away the vial out of the reach of children even if it is not empty.
• Wash your hands to remove any medication.

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

If cyclosporine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed and out of reach of children.
• Store this medication at room temperature and away from excess heat and moisture (not in the bathroom).
• Do not store this medicine in the refrigerator and do not freeze it.
• Oral cyclosporine: throw away any medication that is outdated or no longer needed.
• Throw away any remaining oral solution 2 months after you first open the bottle. Talk to your pharmacist about the proper disposal of your medication.
• Opened vials of cyclosporine eye drops must be discarded after use.

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune® (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Sandimmune (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune and Neoral are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed.