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    Sandimmune Ampul

    GENERIC NAME(S): Cyclosporine

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    WARNINGS:

    Cyclosporine lowers your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect may also increase your risk of getting certain types of cancer (such as skin cancer, lymphoma). Tell your doctor right away if you have any signs of infection or cancer, such as sore throat that doesn't go away, fever, chills, cough, burning/frequent urination, unusual skin changes, change in appearance or size of moles, unusual weight loss, swollen lymph glands, unusual lumps, night sweats.

    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. Your doctor will monitor your blood pressure and kidney function while you use this medication.

    Psoriasis patients who have had certain previous treatments (such as coal tar, methotrexate, radiation treatment, light treatment with PUVA/UVB) are at increased risk to develop skin cancer. Talk to your doctor of the risks and benefits of this medication.

    Who should not take Sandimmune Ampul?
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    Uses

    Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually used along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.

    Because of the risk of severe allergic reactions from intravenous cyclosporine, it should only be used by patients who are unable to take cyclosporine by mouth. Once you are able to take medications by mouth, you should be switched from this form of cyclosporine to either the capsules or oral solution.

    How to use Sandimmune Ampul

    This medication is given by injection into a vein as directed by your doctor, usually once daily over 2 to 6 hours. The dosage is based on your weight, medical condition, lab tests, and response to treatment.

    If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

    When cyclosporine is given into a vein, one of the other ingredients in this product (polyoxyethylated castor oil) may rarely cause a serious allergic reaction. If you are using this medication at home, be prepared to self-treat as directed by your doctor if symptoms of an allergic reaction occur. (See also Side Effects section.)

    Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

    Side Effects

    See also Warning section.

    Shaking, headache, dizziness, unusual growth of body hair, nausea/vomiting, diarrhea, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    Unusual growth and swelling of the gums may occur. Brush your teeth and floss daily to reduce this problem. See your dentist regularly.

    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.

    This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

    Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as a change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal pain), easy bruising/bleeding, unusual tiredness, muscle weakness/spasms, slow/irregular heartbeat, numb/tingling skin, severe leg pain.

    Get medical help right away if you have any very serious side effects, including: mental/mood changes (such as confusion, difficulty concentrating), vision changes, problems with speech, clumsiness, loss of coordination, weakness on one side of the body, chest pain, seizures.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), flushing, 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 or at www.fda.gov/medwatch.

    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 using 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 (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, cancer, skin lesions of unknown cause, radiation treatment (including light treatment with PUVA or UVB), mineral imbalance (such as low level of magnesium or high level of potassium), recent/current infections, high cholesterol/triglycerides levels.

    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 medication may contain alcohol. Caution is advised if you are pregnant or breast-feeding or have liver disease, alcohol dependence, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

    Cyclosporine can make you more likely to get infections or may worsen any current infections. 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 medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.

    This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Older adults may be at greater risk for kidney problems or high blood pressure while using this drug.

    During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. 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.

    Interactions

    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: coal tar, orlistat, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone), tacrolimus.

    Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include boceprevir, bosentan, mifepristone, St. John's wort, telaprevir, 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, dabigatran, dronedarone, simeprevir, certain statins (such as pitavastatin, simvastatin), voxilaprevir, among others.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Lab and/or medical tests (such as kidney/liver function, blood pressure, blood mineral levels, cyclosporine blood levels, complete blood count, uric acid levels, lipid levels, skin exam) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

    If you have had an organ transplant, attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, and pain around the transplanted organ. Also learn the signs of a failing transplanted organ, such as 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. Get medical help right away if these symptoms of rejection occur.

    Missed Dose

    For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

    Storage

    Consult the product instructions and your pharmacist for storage details. Keep all medications 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.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.

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    Sandimmune 250 mg/5 mL intravenous solution
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    Sandimmune 250 mg/5 mL intravenous solution
    Sandimmune 250 mg/5 mL intravenous solution

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    This medicine is a clear, clear, solution

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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