Generics Name

INDICATIONS AND USAGE

Prophylaxis of Organ Rejection in Kidney Transplant

Tacrolimus capsules, USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus capsules, USP be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules, USP.

Prophylaxis of Organ Rejection in Liver Transplant

Tacrolimus capsules, USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus capsules, USP be used concomitantly with adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules, USP.

Prophylaxis of Organ Rejection in Heart Transplant

Tacrolimus capsules, USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that tacrolimus capsules, USP be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules, USP.

Limitations of Use

Tacrolimus capsules, USP should not be used simultaneously with cyclosporine.
Tacrolimus injection should be reserved for patients unable to take tacrolimus capsules, USP orally.

WARNINGS AND PRECAUTIONS
Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus capsules, USP with sirolimus has not been established in kidney transplant.

PATIENT INFORMATION

Tacrolimus Capsules, USP

Read this Patient Information before you start taking tacrolimus capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Tacrolimus Capsules?

Tacrolimus Capsules can cause serious side effects, including:

1. Increased risk of cancer. People who take tacrolimus capsules have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma). 

2.Increased risk of infection. Tacrolimus capsules are a medicine that affects your immune system. Tacrolimus capsules can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving tacrolimus capsules that can cause death. Call your doctor right away if you have symptoms of an infection such as:

fever

sweats or chills

cough or flu-like symptoms

muscle aches

warm, red, or painful areas on your skin

What are Tacrolimus Capsules?

Tacrolimus capsules are a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant and tacrolimus capsules are not for use with medicines called cyclosporines (Gengraf®, Neoral®, and Sandimune®).

Tacrolimus capsules are not for use with a medicine called sirolimus (Rapamune®) in people who have had a liver or heart transplant.

It is not known if tacrolimus capsules are safe and effective when used with sirolimus in people who have had kidney transplants.

It is not known if tacrolimus capsules are safe and effective in children who have had a kidney or heart transplant.Who should not take Tacrolimus Capsules? Do not take Tacrolimus Capsules if you are allergic to tacrolimus or any of the ingredients in tacrolimus capsules. See the end of this leaflet for a complete list of ingredients in tacrolimus capsules.

What should I tell my doctor before taking Tacrolimus Capsules?

Before you take Tacrolimus Capsules, tell your doctor if you:

plan to receive any live vaccines

have or have had liver, kidney or heart problems

are pregnant or plan to become pregnant. Tacrolimus capsules may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Are breastfeeding or plan to breastfeed. Tacrolimus capsules can pass into your breast milk. You and your doctor should decide if you will take tacrolimus capsules or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

cyclosporine (Gengraf®, Neoral®, and Sandimune®)

sirolimus (Rapamune®)

nelfinavir (Viracept®)

telaprevir (Incivek™)

boceprevir (Victrelis™)

amiodarone (Cordarone™, Nexterone™, Pacerone™)

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Tacrolimus capsules may affect the way other medicines work, and other medicines may affect how tacrolimus capsules works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tacrolimus Capsules?

Take tacrolimus capsules exactly as your doctor tells you to take it.

Your doctor will tell you how many tacrolimus capsules to take and when to take them.

Your doctor may change your tacrolimus capsules dose if needed. Do not stop taking or change your dose of tacrolimus capsules without talking to your doctor.

Take tacrolimus capsules with or without food.

Take tacrolimus capsules the same way every day. For example, if you choose to take tacrolimus capsules with food, you should always take tacrolimus capsules with food.

Take tacrolimus capsules at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m. you should take your second dose at 7:00 p.m.

Taking tacrolimus capsules at the same time each day helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs.

Do not eat grapefruit or drink grapefruit juice while taking tacrolimus capsules.

If you take too much tacrolimus capsules, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Tacrolimus Capsules?

While you take tacrolimus capsules you should not receive any live vaccines such as:

flu vaccine through your nose

measles

mumps

rubella

polio by mouth

BCG (TB vaccine)

yellow fever

chicken pox (varicella)

typhoid

Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

What are the possible side effects of Tacrolimus Capsules?

Tacrolimus Capsules may cause serious side effects, including: See “What is the most important information I should know about Tacrolimus Capsules?”

high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take tacrolimus capsules. Call your doctor right away if you have:

frequent urination

increased thirst or hunger

blurred vision

confusion

drowsiness

loss of appetite

fruity smell on your breath

nausea, vomiting, or stomach pain

kidney problems. Your doctor may do certain tests to check your kidney function while you take tacrolimus capsules.

nervous system problems. Call your doctor right away if you get any of these symptoms while taking tacrolimus capsules. These could be signs of a serious nervous system problem:

confusion

coma

muscle tremors

numbness and tinglin

headache

seizures

vision changes

high levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take tacrolimus capsules.

high blood pressure. Your doctor will monitor your blood pressure while you take tacrolimus capsules.

heart problems (myocardial hypertrophy). Tell your doctor right away if you get any of these symptoms of heart problems while taking tacrolimus capsules:

shortness of breath

chest pain

feel lightheaded

feel faint

The most common side effects of Tacrolimus Capsules in people receiving kidney transplant are:

infection

tremors (shaking of the body)

high blood pressure

kidney problems

constipation

diarrhea

headache

stomach pain

trouble sleeping

nausea

low levels of phosphate in your blood

swelling of the hands, ankles, or legs

weakness

pain

high levels of fat in your blood

high levels of potassium in your blood

low red blood cell count (anemia)

The most common side effects of Tacrolimus Capsules in people receiving liver transplants are:

shaking of the body tremors

headache

diarrhea

high blood pressure

nausea

kidney problems

stomach pain

trouble sleeping

numbness or tingling in your hands or feet

anemia

pain

fever

weakness

high levels of potassium in the blood

low levels of magnesium in the blood

The most common side effects of tacrolimus capsules for heart transplant patients are:

kidney problems

high blood pressure

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tacrolimus capsules. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tacrolimus Capsules?
Store tacrolimus capsules at 20° to 25°C (68° to 77° F).
Safely throw away medicine that is out of date or no longer needed.

Keep Tacrolimus Capsules and all medicines out of reach of children.

General information about the safe and effective use of Tacrolimus Capsules Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use  tacrolimus capsules for a condition for which it was not prescribed. Do not give tacrolimus capsules to other people, even if they have the same symptoms that you have. It may harm them.

How do Tacrolimus Capsules protect my new organ? The body’s immune system protects the body against anything that it does not recognize as part of the body. For example, when the immune system detects a virus or bacteria it tries to get rid of it to prevent infection. When a person has a liver, kidney, or heart transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too. This is called “rejection”. Tacrolimus capsules protect your new organ by slowing down the body’s immune system.

This Patient Information leaflet summarizes the most important information about tacrolimus capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about tacrolimus capsules that is written for health professionals.

For more information contact Taj Pharma
What are the ingredients in Tacrolimus Capsules?
Active ingredient: tacrolimus
Inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate.
The tacrolimus capsule shell for 0.5 mg strength consists of gelatin, titanium dioxide and yellow iron oxide.The tacrolimus capsule shell for 1 mg strength consists of black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.The tacrolimus capsule shell for 5 mg strength consists of red iron oxide, gelatin, and titanium dioxide. Tacrolimus capsules 0.5 mg, 1 mg and 5 mg are printed with edible black ink. The black ink is comprised of ammonia, black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, and shellac.