Generic Name: tacrolimus (ta-KROE-li-mus)
Brand Name: Prograf
Prograf capsules decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, fever, chills, persistent sore throat) or any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.
Prograf capsules is used for:
Preventing organ rejection in certain patients following liver, kidney, or heart transplant. It may be used along with other medicines. It may also be used for other conditions as determined by your doctor.
Prograf capsules is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.
Do NOT use Prograf capsules if:
- you are allergic to any ingredient in Prograf capsules
- you are taking asenapine, cisapride, citalopram, a potassium-sparing diuretic (eg, spironolactone), mifepristone, a streptogramin (eg, dalfopristin, quinupristin), or ziprasidone
- you have taken cyclosporine within the last 24 hours
Contact your doctor or health care provider right away if any of these apply to you.
Before using Prograf capsules:
Some medical conditions may interact with Prograf 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 any type of infection, or a history of chronic (long-term) infection
- if you have diabetes or high blood sugar, high blood potassium levels, high blood pressure, or a weakened immune system
- if you have a history of a certain type of anemia (pure red cell aplasia [PRCA]); heart, kidney, or liver problems; skin cancer; or if a member of your family has had skin cancer
- if you have recently received or will be receiving a live vaccine (eg, measles, mumps), or if you will be in close contact with anyone who has received a live vaccine
- if you are taking other medicines to suppress your immune system
- if you are taking a medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Some MEDICINES MAY INTERACT with Prograf 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 birth control, cancer, infections, inflammation, aches and pains, heartburn or reflux, hepatitis, high blood pressure, high cholesterol, HIV infection, hormone replacement therapy, Huntington disease, immune system suppression, irregular heartbeat or other heart problems, mental or mood problems, nausea and vomiting, pain, Parkinson disease, seizures, stomach or bowel problems, ulcers), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with Prograf capsules. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Prograf capsules.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Prograf 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 Prograf capsules:
Use Prograf capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Prograf capsules. Talk to your pharmacist if you have questions about this information.
- Take Prograf capsules by mouth with or without food. It is important to take it consistently with regard to food. 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 taking Prograf capsules.
- Take Prograf capsules 12 hours apart at the same times each day.
- Continue to take Prograf capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Prograf 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 the next day. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Prograf capsules.
Important safety information:
- Prograf capsules may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prograf capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT stop taking Prograf capsules or change your dose without checking with your doctor.
- Prograf capsules may increase your risk of developing skin cancer or certain other types of cancer (eg, lymphoma). To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Tell your doctor right away if you notice a change in the appearance or size of a mole, unusual itching, fever, night sweats, unexplained weight loss, swollen lymph nodes, or unusual growths or lumps.
- Tell your doctor or dentist that you take Prograf capsules before you receive any medical or dental care, emergency care, or surgery.
- Check with your doctor before you drink alcohol while you are taking Prograf capsules.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Prograf capsules 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; sweats or chills; severe or persistent sore throat; cough or flu-like symptoms; muscle aches; or warm, red, or painful areas on your skin.
- Prograf capsules may increase the risk of severe and sometimes fatal viral infections (eg, JC virus or BK virus infection). JC virus infection may lead to a serious effect called progressive multifocal leukoencephalopathy (PML). BK virus may cause kidney problems or loss of a transplanted kidney in kidney transplant patients. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; 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).
- Some patients treated with Prograf capsules have developed a type of anemia called PRCA. Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Prograf capsules. Talk with your doctor before you receive any vaccine.
- Patients who take Prograf capsules after an organ transplant may have an increased risk of developing high blood sugar or diabetes. The risk is higher among black and Hispanic patients after a kidney transplant. High blood sugar may make you feel confused, drowsy, hungry, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including blood potassium or glucose levels; blood levels of Prograf capsules; heart, liver, or kidney function; and blood pressure may be performed while you take Prograf capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Caution is advised when using Prograf capsules in CHILDREN; they may be more sensitive to its effects.
- Prograf capsules should be used with extreme caution in CHILDREN who have had a heart or kidney transplant; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Prograf capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Prograf capsules while you are pregnant. Prograf capsules is found in breast milk. Do not breast-feed while taking Prograf capsules.
Possible side effects of Prograf capsules:
All medicines 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:
Back pain; constipation; diarrhea; dizziness; headache; heartburn; joint pain; loss of appetite; mild stomach pain or upset; nausea; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; burning, numbness, or tingling; changes in the appearance or size of a mole; chest pain; confusion; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; memory problems; mental or mood changes (eg, agitation, anxiety, depression); muscle cramps, pain, or weakness; night sweats; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, light-headedness, or headache; shortness of breath; sluggishness; swelling of the hands, ankles, feet, or legs; swollen lymph nodes; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; loss of appetite; unusual drowsiness); symptoms of kidney or urinary problems (eg, change in the amount of urine produced; difficult or painful urination; dark or bloody urine; pain in the groin, side, or lower back); tremor; trouble speaking; unusual bruising or bleeding; unusual growths or lumps; unusual or persistent weakness or tiredness; unusually pale skin; 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. Symptoms may include decreased urination; hives; severe dizziness or headache; sluggishness; swelling of the hands, ankles, feet, or legs; tremors.Proper storage of Prograf capsules:
Store Prograf capsules between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prograf capsules out of the reach of children and away from pets.
- If you have any questions about Prograf capsules, please talk with your doctor, pharmacist, or other health care provider.
- Prograf capsules 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Prograf 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 Prograf capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prograf 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 healthcare provider for complete information about the risks and benefits of using Prograf 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.