GENERIC NAME: CYCLOSPORINE MICROEMULSION CAPSULE - ORAL (sye-klo-SPORE-een MY-crow-ee-MULL-shun)
BRAND NAME(S): Gengraf, Neoral
WARNING: Cyclosporine is a drug that reduces the body's ability to fight illness/disease (an immunosuppressant), leaving patients vulnerable to infection or other problems (including cancers such as lymphoma). Using other drugs that treat organ transplant rejection along with this drug may increase these tendencies.
Cyclosporine can also cause high blood pressure and kidney problems. The risk of both problems increases with higher doses and longer treatment with this drug. Psoriasis patients who have had certain previous treatments (e.g., coal tar, methotrexate, PUVA, UVB, or other radiation therapy) are at increased risk to develop skin cancer. Therefore, cyclosporine must be given only under close medical supervision.
Because different brands deliver different amounts of medication, do not switch brands of cyclosporine without your doctor's permission and directions.
Laboratory tests (e.g., kidney function tests, blood tests) may be performed to monitor your progress.
USES: This medication is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe rheumatoid arthritis and a certain skin condition (severe psoriasis). Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting a transplanted organ, further damaging your joints (in rheumatoid arthritis patients), or further damaging your skin (in psoriasis patients). For the treatment of psoriasis or arthritis, it is generally used to treat people who cannot take other medications or have not found relief from other treatments.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used to prevent rejection in other types of organ transplants (e.g., cornea, pancreas) or bone marrow transplant. It may also be used to treat other conditions that may be helped by affecting the immune system (e.g., Crohn's disease).
HOW TO USE: Take this medication by mouth, usually twice daily at the same times each day, or take as directed by your doctor. You may take this medication with or without food, but you should choose one or the other and take every dose that way. If you take this medication with food, eat the same amount and type of food each time you take it. Swallow this medication whole. Do not crush or chew the capsules. Dosage is based on your medical condition, cyclosporine blood level, kidney function, and response to therapy. Follow the dosing schedule for this medication carefully.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit products can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.If you are taking this drug to treat arthritis, it may take 4-8 weeks to notice improvement, and up to 4 months for the full benefit.If you are taking this drug to treat psoriasis, it may take 2-4 weeks to notice improvement, and up to 4 months for the full benefit. Your dose will slowly be increased during your therapy with this drug. Inform your doctor if your condition does not improve after 6 weeks of taking the highest recommended dose. If you are taking this medication to treat psoriasis, do not take it continuously for longer than one year unless directed to do so by your doctor.
SIDE EFFECTS: See also the Warning section.Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Your risk of infection may be higher while you are taking this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination.Tell your doctor right away if you have any serious side effects, including: muscle spasms/weakness, fast/irregular heartbeat, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes (such as confusion, difficulty concentrating), vision changes, swollen glands, unusual lumps, night sweats, problems with speech, clumsiness, loss of coordination, weakness on one side of the body.Get medical help right away if you have any very serious side effects, including: chest pain, seizures.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chicken pox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only).Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, any recent/current infections, seizures, untreated mineral imbalance (e.g., low magnesium or high potassium), blood disorders, diabetes, a certain gut problem (malabsorption), high blood fats (cholesterol or triglycerides).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.This drug may reduce the magnesium levels in your blood. Ask your doctor about adding magnesium to your diet. Your doctor may prescribe a magnesium supplement.Cyclosporine can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This drug may increase your risk for developing skin cancer. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication may cause swelling and growth of the gums (gingival hyperplasia). Brush your teeth and floss daily to minimize this problem. See your dentist regularly.This medication may contain alcohol. Caution is advised if you have liver disease, alcohol dependence, seizures, or any other condition that require you to limit/avoid alcohol in your diet. Caution is also advised if you are pregnant or breast-feeding. Carefully watch children while they use this medication. Ask your doctor or pharmacist about using this product safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).The elderly may be at greater risk for the effects on blood pressure and kidneys while using this drug.This medication should be used only when clearly needed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other more serious problems have also been reported, including death of the unborn baby. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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DRUG INTERACTIONS: See also the How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: birth control pills, caspofungin, coal tar, ezetimibe, sulfinpyrazone, tacrolimus, temsirolimus, terbinafine, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that worsen kidney problems (e.g., acyclovir, aminoglycoside antibiotics including tobramycin; amphotericin B; colchicine; fibrates including fenofibrate; melphalan; NSAIDs including diclofenac and sulindac; ranitidine; sulfa drugs including sulfamethoxazole; vancomycin), drugs that may increase potassium levels (e.g., ACE inhibitors including lisinopril, ARBs including losartan, potassium supplements, "water pills" including amiloride, spironolactone).Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include allopurinol, amiodarone, azole antifungals including fluconazole, barbiturates including phenobarbital, boceprevir, bosentan, bromocriptine, calcium channel blockers including diltiazem/nifedipine/verapamil, cimetidine, HIV protease inhibitors including indinavir, imatinib, certain man-made male hormones such as danazol/methyltestosterone, methylprednisolone, metoclopramide, metronidazole, mifepristone, nafcillin, nefazodone, octreotide, orlistat, quinupristin/dalfopristin, rifamycins including rifampin/rifabutin, certain anti-seizure drugs including carbamazepine/phenytoin, St. John's wort, telaprevir, ticlopidine, among others.This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, ambrisentan, digoxin, dronedarone, etoposide, repaglinide, tolterodine, statins (such as atorvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin), other immunosuppressants (such as azathioprine, methotrexate, sirolimus), among others.Do not use potassium-containing salt substitutes while taking this medication. Consult your doctor or pharmacist for more information.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Keep all laboratory and medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function, blood pressure, blood mineral levels, uric acid, cyclosporine blood levels) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.Have your blood pressure checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure. Inform your doctor of your blood pressure readings.If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Seek immediate medical attention if these symptoms of rejection occur.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the original foil container at room temperature away from heat and moisture. Different storage temperatures are needed for drugs from different manufacturers, so consult your pharmacist for more information. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.
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