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Product description Safety information Side Effects

Drug Name

Tacroz Forte Ointment 0.1% w/v (Generic Tacrolimus Ointment)

Drug Uses

Tacroz Forte Ointment is used for preventing organ rejection in 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.

How to use

Use Tacroz Forte Ointment exactly as directed.

Do not use more or less of it or use it more often than prescribed by your doctor. To use the ointment, follow these steps:

• Wash your hands with soap and water. Be sure that the skin in the affected area is dry.
• Apply a thin layer of tacrolimus ointment to all affected areas of your skin. Rub the ointment into your skin gently and completely.
• Wash your hands with soap and water to remove any Tacroz Forte Ointment. Do not wash your hands if you are treating them with tacrolimus.
• You may cover the treated areas with normal clothing, but do not use any bandages, dressings, or wraps.
• Be careful not to wash the ointment off of affected areas of your skin. Do not swim, shower, or bathe immediately after applying tacrolimus ointment.

Drug Class and Mechanism

Tacroz Forte Ointment is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Missed Dose

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Storage

Store Tacroz Forte Ointment at room temperature, between 59 and 80 degrees F (15 and 26 degrees C). Store in a tightly closed container. Store away from heat and light. Keep Tacroz Forte Ointment out of the reach of children and away from pets.

Warnings/Precautions

Do NOT use Tacroz Forte Ointment if:

• you are allergic to any ingredient in Tacroz Forte Ointment, including castor oil
• you are taking astemizole, cisapride, dofetilide, ibutilide, a potassium-sparing diuretic (eg, spironolactone), sirolimus, terfenadine, or ziprasidone
• you have taken cyclosporine with the last 24 hours

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tacroz Forte Ointment:
Some medical conditions may interact with Tacroz Forte Ointment. 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 heart, kidney, or liver problems; diabetes; or high potassium levels in your blood

Some MEDICINES MAY INTERACT with Tacroz Forte Ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased
• Cyclosporine or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cisplatin, cyclosporine, ganciclovir, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, high cholesterol, seizures, stomach problems), multivitamin products, herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort), astemizole, cisapride, dofetilide, ibutilide, sirolimus, terfenadine, and ziprasidone may interact with Tacrolimus , increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tacrolimus 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.

Possible Side Effects

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:
Back pain; constipation; diarrhea; dizziness; headache; joint pain; loss of appetite; nausea; stomach pain or upset; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased coordination; chest pain; diabetes (frequent urination, increased thirst or hunger); fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, anxiety, confusion) one-sided weakness; painful urination or changes in the amount of urine; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; shortness of breath; swelling of the hands, feet, or legs; tingling or numbness in the hands or feet; tremor; trouble speaking; unusual bruising or bleeding; unusual lumps or skin lesions; unusual weakness or tiredness; vision changes; yellowing of the skin or eyes.

More Information

If you have any questions about Tacroz Forte Ointment, please talk with your doctor, pharmacist, or other health care provider.

Tacroz Forte Ointment 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.