Sandimmune soft gelatin capsules
Generic Name: cyclosporine (SYE-kloe-SPOR-in)
Brand Name: Sandimmune
Sandimmune soft gelatin capsules should be used with adrenal corticosteroids (eg, hydrocortisone). It should not be used with other medicines that suppress the immune system. Suppressing the immune system may increase the risk of developing an infection or a certain type of cancer (lymphoma).
Sandimmune soft gelatin capsules cannot be switched with other forms of cyclosporine (eg, Neoral) without your doctor's approval.
If you are taking Sandimmune soft gelatin capsules for a long period of time, lab tests should be performed to monitor your progress or to check for side effects. This is especially important for liver transplant patients.
Sandimmune soft gelatin capsules are 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 soft gelatin capsules are an immunosuppressant. It works by suppressing the immune system. This prevents the body from rejecting transplanted organs.
Do NOT use Sandimmune soft gelatin capsules if:
- you are allergic to any ingredient in Sandimmune soft gelatin capsules
- you are taking aliskiren, amiloride, bosentan, dabigatran, orlistat, spironolactone, or triamterene
- you are taking another medicine to suppress the immune system (eg, azathioprine, sirolimus)
- you are having radiation therapy, including psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy, for psoriasis
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sandimmune soft gelatin capsules:
Some medical conditions may interact with Sandimmune soft gelatin capsules. 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; gout or high blood uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; a weakened immune system; or problems absorbing food or medicine
- if you have high blood potassium levels or your diet contains a lot of potassium
- if you have a history of seizures
- if you are having phototherapy for psoriasis or are having radiation treatment
- if you have recently had or will be having a vaccine
- if you are taking medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
Some MEDICINES MAY INTERACT with Sandimmune soft gelatin capsules. 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 aches and pains, allergic reactions, arthritis, asthma, birth control, blood thinning, cancer, diabetes, endometriosis, fibrocystic breast disease, gout, heartburn or reflux, hepatitis C, high blood pressure, high blood prolactin levels, HIV, infection, immune system suppression, inflammation, high cholesterol, irregular heartbeat or other heart problems, mental or mood problems, Parkinson disease, psoriasis, pulmonary arterial hypertension [PAH], sleep, stomach or bowel problems, seizures, weight loss), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with Sandimmune soft gelatin capsules. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Sandimmune soft gelatin capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sandimmune soft gelatin capsules 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 soft gelatin capsules:
Use Sandimmune soft gelatin capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Sandimmune soft gelatin capsules on a regular schedule with regard to food and time(s) of day. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
- Do not eat grapefruit or drink grapefruit juice while you take Sandimmune soft gelatin capsules.
- Continue to take Sandimmune soft gelatin capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Sandimmune soft gelatin capsules, 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 soft gelatin capsules.
Important safety information:
- Tell your doctor or dentist that you take Sandimmune soft gelatin capsules before you receive any medical or dental care, emergency care, or surgery.
- Do not switch to another doseform or change brands of Sandimmune soft gelatin capsules without talking to your doctor. Products made by other companies may not work as well for you.
- Sandimmune soft gelatin capsules may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sandimmune soft gelatin capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.
- Sandimmune soft gelatin capsules may lower the ability of your body to fight infection. This may increase the risk of serious and sometimes fatal infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.
- Some patients treated with Sandimmune soft gelatin capsules have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; you do not care about things that you usually care about; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine).
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune soft gelatin capsules. Talk with your doctor before you receive any vaccine.
- Sandimmune soft gelatin capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Diabetes patients - Sandimmune soft gelatin capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Have your blood pressure checked as you have been told by your doctor.
- Lab tests may be performed while you use Sandimmune soft gelatin capsules. 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 soft gelatin capsules with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Sandimmune soft gelatin capsules 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 soft gelatin capsules while you are pregnant. Sandimmune soft gelatin capsules are found in breast milk. Do not breast-feed while taking Sandimmune soft gelatin capsules.
Possible side effects of Sandimmune soft gelatin capsules:
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; mild diarrhea; 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 stools; burning, numbness, or tingling; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased coordination; fast or irregular heartbeat; gum disease or overgrowth; mental or mood changes (eg, depression); mouth sores or swelling; muscle aches, cramps, pain, or weakness; ringing in the ears or hearing loss; seizures; severe or persistent diarrhea; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden unusual sweating; symptoms of infection (eg, chills, fever, increased or painful urination, sore throat, severe or persistent cough, warm or painful skin); symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite); tremor; unusual bleeding or bruising; unusual lumps; unusual swelling; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes (eg, blindness); vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Sandimmune soft gelatin capsules:
Store Sandimmune soft gelatin capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sandimmune soft gelatin capsules out of the reach of children and away from pets.
- If you have any questions about Sandimmune soft gelatin capsules, please talk with your doctor, pharmacist, or other health care provider.
- Sandimmune soft gelatin capsules are 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Sandimmune soft gelatin capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sandimmune soft gelatin capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sandimmune soft gelatin capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Sandimmune soft gelatin capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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