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Generic Name: Cyclosporine Oral Solution (SYE-kloe-spor-een)
Brand Name: Sandimmune
Sandimmune Solution should always be used along with adrenal corticosteroids
(eg, hydrocortisone), but not with other medicines that suppress the immune system. The risk of developing an infection or a certain type of cancer (lymphoma)
may be increased by suppressing the immune system.
Sandimmune Solution cannot be interchanged with other forms of cyclosporine
(eg, Neoral) without your doctor"s approval.
If you are taking Sandimmune Solution for a long period of time, especially for a liver transplant, lab tests should be performed to monitor your progress or to check for side effects such as toxicity or decreased effectiveness.
Sandimmune Solution is used for:
Preventing the rejection of organ transplants (kidney, liver, and heart). It
is used in combination with adrenal corticosteroids. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents. It may also be used for other conditions as determined by your doctor.
Sandimmune Solution is an immunosuppressant. How Sandimmune Solution works is not fully understood, but it may block certain white blood cells (lymphocytes).
Do NOT use Sandimmune Solution if:
- you are allergic to any ingredient in Sandimmune Solution
- you are taking bosentan, disulfiram, fluorouracil, an immunosuppressant
(eg, azathioprine, tacrolimus), metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)
- you are having radiation therapy for psoriasis
- you are going to be vaccinated with a live vaccine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sandimmune Solution:
Some medical conditions may interact with this
medicine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; gout; an infection; or problems absorbing food or medicine;
or have had a recent vaccination
- if your diet contains high amounts of potassium
- if you have a history of seizures
Some MEDICINES MAY INTERACT with Sandimmune Solution. Tell your health care provider if you are taking any other medicines, especially
any of the following:
- Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements
(eg, St. John"s wort) may interact with Sandimmune Solution. They may increase the risk of side effects or decrease the effectiveness of this or other medicines
- Immunosuppressants (eg, azathioprine, tacrolimus) because risk of developing an infection or cancer may be increased
- Potassium-sparing diuretics (eg, spironolactone
because the risk of high blood potassium levels may be increased
- Bosentan because the risk of its side effects and toxic effects may be increased by Sandimmune Solution
- Orlistat because it may decrease Sandimmune Solution"s effectiveness
- Disulfiram, fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sandimmune Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sandimmune Solution:
Use Sandimmune Solution as directed by your doctor. Check the label on the
medicine for exact dosing instructions.
- Take Sandimmune Solution on a regular schedule with regard to food and time of day.
- Do not eat grapefruit or drink grapefruit juice while you use Sandimmune Solution.
- If you also take sirolimus, do not take it within 4 hours after taking Sandimmune Solution. Check with your doctor if you have questions.
- Follow your doctor"s instructions on how to dilute Sandimmune Solution. Use a glass container to mix Sandimmune Solution. To improve the flavor, Sandimmune Solution may be mixed with room temperature milk, chocolate milk, or orange juice.
- Avoid frequently switching the liquid in which you mix Sandimmune Solution. Stir well and drink immediately (do not let it stand before drinking). Rinse glass with more liquid and drink again to make sure the entire dose is taken.
- Do not rinse the dosing syringe with water or other agents; this will affect the dose. After use, dry the outside of the dosing syringe with a clean
towel and replace the protective cover. If the syringe needs to be cleaned, it must be completely dry before it is used again.
- If you miss a dose of Sandimmune Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Sandimmune Solution.
Important safety information:
- Sandimmune Solution may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sandimmune Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not switch to another doseform or change brands of Sandimmune Solution without talking to your doctor. Products made by other companies may not work as well for you.
- Sandimmune Solution may increase your risk of skin cancer. Avoid the sun,
sunlamps, or tanning booths until you know how you react to Sandimmune Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Sandimmune Solution may increase risk of developing certain forms of cancer. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune Solution. Talk with your doctor before you receive any vaccine.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Sandimmune Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Tell your doctor or dentist that you take Sandimmune Solution before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - Sandimmune Solution may
affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including kidney and liver function tests; cyclosporine levels;
and blood pressure, lipids, and electrolytes, may be performed while you use Sandimmune Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Sandimmune Solution with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Sandimmune Solution may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sandimmune Solution while you are pregnant. Sandimmune Solution is found in breast milk. Do not breast-feed while taking Sandimmune Solution.
Possible side effects of Sandimmune Solution:
All medicines may cause side effects, but many
people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; dizziness; flushing; headache; increased hair growth; nausea;
runny nose; sleeplessness; stomach discomfort; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stool; blood in the urine; chest pain; chills; confusion; dark urine;
diarrhea; fast or irregular heartbeat; fever; gum disease or overgrowth; increased or decreased urination; infection; loss of coordination; mental or mood changes;
muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; sore throat; tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or lesion of the skin;
unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.
Proper storage of Sandimmune Solution:
Store Sandimmune Solution at room temperature, below 80 degrees F (30 degrees C), in its original container. Store away from heat, moisture, and light. Do not store in refrigerator. Protect from freezing. Once opened, the contents must be used within 2 months. Do not
store in the bathroom. Keep Sandimmune Solution out of the reach of children and away from pets.
- If you have any questions about Sandimmune Solution, please talk with your doctor, pharmacist, or other health care provider.
- Sandimmune Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Sandimmune Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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