TACROLIMUS (ORAL AND INJECTION)

(ta KROE li mus) Brand: Prograf

What is the most significant information I must know about tacrolimus?

• Tacrolimus may magnify your risk of developing serious infections, cancer, or transplant failure. Conversation with your doctor about the risks and benefits of using this medicine.

• You will need regular medical trials to be certain tacrolimus is not causing deleterious effects. Do not miss any follow up visits to your doctor for blood or urine trials. Avoid being around people who are sick or have infections.

• Tacrolimus can harm your kidneys, and this effect is heighten when you also use determined another medicines deleterious to the kidneys. Till using tacrolimus, speak your doctor about all another medicines you use. Much another drugs (including some over-the-counter medicines) can be deleterious to the kidneys.

• Call your doctor right away if you have symptoms of a serious brain infection, such as a change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

What is tacrolimus?

• Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

• Tacrolimus is used together with another medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

• Tacrolimus may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking tacrolimus?

• You must not use this medicine if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.

• Tacrolimus can lower blood cells that help your body fight infections, or reason your body to manufacture too many of a determined type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer, a severe brain infection that can lead to disability or death, or a virus that can reason failure of a transplanted kidney.

• Using tacrolimus may magnify your risk of developing skin cancer, especially if you are treated over long periods of time with drugs that weaken the immune system. Conversation with your doctor about your specific risk.

• Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most often in people who are Hispanic or African-American. Conversation with your doctor about your individual risk of diabetes if you have concerns.

• To create certain you can safely take tacrolimus, speak your doctor if you have any of these another conditions:

· kidney or liver disease;

· heart malady, tall blood pressure, tall cholesterol or triglycerides (a type of thick in the blood);

· if you also use sirolimus (Rapamune); or

· if you are using another drugs that weaken your immune system such as cancer medication or steroids.

• FDA pregnancy category C. It is not known whether tacrolimus will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• Tacrolimus can pass into breast milk and may harm a nursing child. You must not breast-feed while you are using tacrolimus.

How must I take tacrolimus?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results.

• You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given before you are ready to take the pill form of tacrolimus.

• The tacrolimus capsule is generally taken each 12 hours. Take the medication at the same time every day. You may take tacrolimus with or without food, but take it the same way every time.

• You will need regular medical trials to be certain this medicine is not causing deleterious effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking tacrolimus?

• Grapefruit and grapefruit juice may interact with tacrolimus and lead to potentially dangerous effects. Do not use grapefruit commodity while you are taking tacrolimus.

• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.

• Avoid exposure to sunlight or tanning beds. Tacrolimus can create you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

• Do not receive a "live" vaccine while using tacrolimus. The vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of tacrolimus?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);

· pale or yellowed skin, dark colored urine, confusion or weakness;

· feeling light-headed or short of breath, rapid heart course, trouble concentrating;

· pain in the lower back or side, blood in your urine, pain or burning when you urinate;

· urinating smaller than normal or not at all;

· dry cough, cough with mucus or blood, sweating, wheezing, gasping for breath, chest pain;

· tremors (shaking), seizure (convulsions);

· tall potassium (slow heart course, weak pulse, muscle weakness, tingly feeling);

· low magnesium (jerky muscle movements, muscle weakness or limp feeling, slow reflexes);

· tall blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats); or

· tall blood sugar (increased thirst, heighten urination, famine, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

• Smaller serious side effects may include:

· nausea, stomach pain, diarrhea, constipation;

· headache;

· sleep problems (insomnia); or

· swelling in your hands or feet.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect tacrolimus?

• Tacrolimus can harm your kidneys. This effect is heighten when you also use another medicines deleterious to the kidneys, such as: chemotherapy, antiviral medicine, pain or arthritis medication, injected antibiotics, or medicines to treat a bowel mess or prevent organ transplant rejection. You may need doze adjustments or particular trials if you have recently used any of these medications.

• Much drugs can interact with tacrolimus. Adown is just a partial list. Speak your doctor about all another medicines you use, especially:

· another medicines to prevent rejection of a transplanted organ;

· St. John's wort;

· antacids such as Amphojel, Maalox, Mylanta, Rolaids, Rulox, and others;

· an antibiotic such as azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), and others;

· an antidepressant such as desipramine (Norpramin) or nefazodone;

· antifungal medicine such as caspofungin (Cancidas), clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);

· a barbiturate such as phenobarbital (Solfoton);

· birth control pills or hormone replacement;

· heart or blood pressure medicine such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), dronedarone (Multaq), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;

· HIV/AIDS medicine such as atazanavir (Reyataz), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), and others;

· the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);

· seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others;

· steroid medication such as dexamethasone (Cortastat, Dexasone, Solurex, DexPak) or methylprednisolone (Medrol); or

· stomach acid reducers such as cimetidine (Tagamet), lansoprazole (Prevacid), or omeprazole (Prilosec, Zegerid).

• This list is not complete and there are much another drugs that can interact with tacrolimus. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor. Hold a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about tacrolimus.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

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