Brand Name

Prograf Capsules {Astellas}

Generic Name

tacrolimus, pronounced ta KROE li mus

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Prograf Capsules?

Prograf Capsules areprescribed to help prevent the rejection of organ transplants, such as heart, kidney and liver transplants. You may be prescribed Prograf Capsules along with other medications.

Prograf Capsules may also be used for reasons not stated in this medication guide.

Key Facts About Prograf Capsules

Prograf Capsules are an immunosuppressant and work by suppressing your immune system which helps to prevent your body from rejecting transplanted organs.

Do not take Prograf Capsules if you are taking another medication to suppress your immune system without talking to your doctor first.

You should try to stay away from people who are ill or have infections, as Prograf Capsules can lower your blood cells that help you to fight infections. Prograf Capsules put you at risk for developing potentially serious infections.

It is important that you contact your doctor immediately if you notice any signs of a potential brain infection, like decreased vision, problems with balance or walking and changes in your mental state.

Tell your doctor if you are pregnant or plan to become pregnant. Prograf Capsules is in FDA pregnancy category C. It is not known that Prograf Capsules can cause health problems in your newborn. Talk to your doctor about using Prograf Capsules if you are pregnant. If you become pregnant while using Prograf Capsules tell your doctor right away. You should not breastfeed while using Prograf Capsules as we know that Prograf Capsules can pass into breast milk and harm a nursing baby.

Before You Take Prograf Capsules

If you are allergic to tacrolimus or hydrogenated castor oil you should not take Prograf Capsules.

If you have used cyclosporine (Gengraf, Neoral or Sandimmune) within the past 24 hours you should not use Prograf Capsules.

Talk to your doctor if you havekidney or liver problems, high cholesterol levels, high triglyceride levels or heart disease before taking Prograf Capsules.

Talk to your doctor before starting treatment with Prograf Capsules if you are using sirolimus (Rapamune).

Some patients who have taken Prograf Capsules after a kidney transplant have developed diabetes. This has been more common in people who are African-American or Hispanic. If you are concerned about developing diabetes after a kidney transplant you should talk to your doctor before using Prograf Capsules.

Taking Prograf Capsules for long periods of time can increase your risk for developing skin cancer. Talk to your doctor if you are concerned about developing skin cancer and take care to protect your skin when you are outdoors with an SPF of 30 or higher.

You should not receive a “live” vaccine while taking Prograf Capsules, as the vaccine may not work as well and not fully protect you from disease you are vaccinating against. Examples of “live” vaccines include the MMR, or measles, mumps and rubella; Bacillus Calmette-Guérin (BCG); oral polio; rotavirus; smallpox; typhoid; yellow fever; varicella (chickenpox); zoster (shingles) and the nasal flu or influenza vaccine.

Prograf Capsules Drug Interactions

You should inform your doctor if you are taking any of the following medications:

• antacids
• antibiotics like azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), rifabutin (Mycobutin) and rifampin (Rifadin, Rifater, Rifamate)
• antidepressants like desipramine (Norpramin) and nefazodone
• antifungal medications like caspofungin (Cancidas), clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil) and voriconazole (Vfend)
• barbiturates like phenobarbital (Solfoton)
• birth control pills or hormone replacements
• heart or blood pressure medications like amiodarone (Cordarone, Pacerone), amlodipine
• Norvasc, Caduet), diltiazem (Cardizem, Cartia), dronedarone (Multaq), nifedipine (Nifedical, Procardia), quinidine (Quin-G) and verapamil (Calan, Covera)
• hepatitis C medications like boceprevir (Victrelis) and telaprevir (Incivek)
• HIV or AIDS medications like atazanavir (Reyataz), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), nelfinavir (Viracept) and ritonavir (Norvir, Kaletra)
• seizure medications like carbamazepine (Carbatrol, Equetro, Tegretol) and phenytoin (Dilantin)
• St. John’s wort
• steroid medications like dexamethasone (Cortastat, Dexason) and methylprednisolone (Medrol)
• stomach acid reducers like cimetidine (Tagamet), lansoprazole (Prevacid) and omeprazole (Prilosec, Zegerid)

Other drugs you take that are not listed may interact with Prograf Capsules. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Prograf Capsules

You should take Prograf Capsules exactly as directed by your doctor. It is important that you do not take Prograf Capsules in larger or smaller amounts, or for longer or shorter than recommended. Follow the directions on your prescription label and follow any dose changes carefully if your doctor instructs you to change your dose.

You should take the Prograf Capsules with a full glass of water, and swallow the capsule whole. Do not break the capsule.

Prograf Capsules should be taken at the same time every day and at regular intervals, usually 12 hours apart. Do not stop taking Prograf Capsules without talking to your doctor first.

Take care to refrain from eating grapefruit products while you are taking Prograf Capsules.

Prograf Capsules needs to be stored at room temperature, and away from light, moisture and heat.

If you miss a dose of Prograf Capsules you should attempt to take the missed dose as soon as you remember. Do not take an extra Prograf Capsule to make up for a missed dose.

Prograf Capsules Side Effects

If you experience any of the following adverse effects you should stop taking Prograf Capsules and seek emergency medical help immediately:

• allergic reactions such as breathing difficulties, hives, or swelling of your face, lips, throat or tongue
• chest pain that may include arm or jaw pain
• confusion and/or decreased coordination
• cough that is dry or with mucous
• flu symptoms
• high blood pressure symptoms like a headache that is severe, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath and rapid or uneven heartbeats
• high blood sugar symptoms like increased thirst, increased urination, hunger, dry mouth, a fruity breath odor, drowsiness, dry skin, blurry vision and weight loss
• high potassium symptoms like a slow heart rate, a weak pulse, muscle weakness and a tingly feeling
• infection signs, such as chills, fever and painful or warm skin
• irregular or rapid heartbeats
• jaundice, with yellowing of your eyes or skin
• lightheadedness
• liver problems such as clay-colored stools and dark urine
• low magnesium symptoms like jerky muscle movements, muscle weakness or a limp feeling and slow reflexes
• seizures
• shortness of breath
• sores in your mouth and throat
• tremors
• urinary problems that may indicate kidney problems, such as blood in your urine
• weakness that is unusual
• wheezing or gasping for breath

Less serious side effects of Prograf Capsules may include:

• constipation
• mild diarrhea
• headache
• insomnia
• nausea
• swelling of your hands and feet
• upset stomach or stomach pain

It should be noted that this is not a complete list of possible side effects of Prograf Capsules. You should contact your physician for a complete list and medical advice regarding these effects.

Prograf Capsules Description and Dosing

Prograf Capsules are available as oblong, hard capsules for oral administration. The 0.5 mg capsule is light-yellow and imprinted in red “0.5 mg” on the capsule cap and “logo607″* on the capsule body. The 1 mg, capsule is white and imprinted in red “1 mg” on the capsule cap and “logo617″* on the capsule body. The 5 mg capsule is grayish-red and imprinted with white “5 mg” on the capsule cap and “logo657″* on the capsule body.

You should consult your doctor for specific dosing pertaining to you. Do not attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Prograf Capsules you should seek emergency help immediately.

Ingredients in Prograf Capsules

Prograf Capsules is comprised of the main ingredient tacrolimus. Other inactive ingredients include lactose monohydrate, hypromellose, croscarmellose sodium and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.