Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TACROLIMUS - ORAL

(tack-row-LEE-muss)

COMMON BRAND NAME(S): Prograf

WARNING: Tacrolimus may leave you less able to fight infection and could also cause tumors. This medication must be used in an appropriate setting. Notify your doctor immediately if you develop signs of infection (such as persistent sore throat or fever), or unusual growths.

Uses

Tacrolimus is used to prevent the body from rejecting a transplanted organ.

OTHER

Uses

This medication may also be used for other purposes as determined by your doctor.

How To Use

Take this medication by mouth exactly as prescribed, usually every 12 hours. It is best taken on an empty stomach 1 hour before or 2 hours after a meal. If stomach upset occurs, you may take this medication with food; however, this may decrease the amount of tacrolimus absorbed into your bloodstream. If you take this on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food. Consult your doctor for more details (since your doctor will be monitoring the amount of this drug in your blood). Your dose may be adjusted based on your response, tolerance, and blood tests (tacrolimus trough blood levels). Follow dosing instructions closely. Do not increase the dose or take this more often than directed since the chance of side effects will be increased. Continue taking this medication as directed even if you are feeling well. Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise.

Side Effects

Tremor, headache, diarrhea, nausea, increased blood pressure, trouble sleeping or tingling of the hands or feet may occur. If any of these effects persist or worsen, notify your doctor promptly. Notify your doctor promptly if you develop: vomiting, dizziness, anxiety, fever, chills, weakness, vision changes, chest pain, easy bruising or bleeding, swelling of the feet or ankles. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular heartbeat. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor if you have: kidney disease, liver disease, high blood pressure, diabetes, any allergies. This medication is not recommended for use if you have the following medical conditions: heart disease (e.g., QT prolongation). This medication is not recommended for use during pregnancy or while breast-feeding. Discuss the risks and benefits with your doctor.

Drug Interactions

Tell your doctor of all over-the-counter or prescription medications you may use, including: cyclosporine, cimetidine, bromocriptine, heart medications (e.g., nifedipine), vaccines, "statin" drugs for high cholesterol, anti-seizure medicines, nefazodone, azole antifungals (e.g., ketoconazole, itraconazole), macrolide antibiotics (e.g., erythromycin, clarithromycin), rifamycins (e.g., rifampin, rifabutin), St. John's wort. Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, quinidine, sotalol, moxifloxacin, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include chest pain, hand tremors, or decrease in amount of urine.

Notes

Laboratory tests will be done frequently while taking this medication to monitor the effects and prevent side effects.

Missed Dose

Take this medication as directed. If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store this medication at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).