Tacrolimus (Page 15 of 16)

17.9 Drug Interactions

Instruct patients to tell their health care providers when they start or stop taking all the medicines, including prescription medicines and non-prescription medicines, natural or herbal remedies, nutritional supplements and vitamins [see Drug Interactions (7)].

17.10 Pregnant Women and Nursing Mothers

Instruct patients to tell their healthcare provider if they plan to become pregnant or breast-feed their infant [see Use in Specific Populations (8.1, 8.3)].

17.11 Immunizations

Inform patients that Tacrolimus Capsules USP can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions (5.16)].

Rx only

Manufactured by:
Panacea Biotec Ltd
Malpur, Baddi,
Distt. Solan (H.P.) – 173205, India

Mfg.Lic.No: MB/05/203

Distributed by:
Kremers Urban Pharmaceuticals Inc.
Princeton, NJ 08540, USA

Resource Number: L5678

Item Code: PPIT057I
Revised Date: July 2015

Patient Information

Tacrolimus Capsules USP
(tacrolimus) capsules USP

Read this Patient Information before you start taking Tacrolimus Capsules USP 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 USP?

Tacrolimus Capsules USP can cause serious side effects, including:

  1. Increased risk of cancer. People who take Tacrolimus Capsules USP have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  2. Increased risk of infection. Tacrolimus Capsule USP is a medicine that affects your immune system. Tacrolimus Capsules USP can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving Tacrolimus Capsules USP 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 is Tacrolimus Capsules USP?

Tacrolimus Capsule USP is 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 Capsule USP is not for use with medicines called cyclosporines (Gengraf® , Neoral® , and Sandimune®).

Tacrolimus Capsule USP is not for use with a medicine called sirolimus (Rapamune®) in people who have had a liver or heart transplants.

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

It is not known if Tacrolimus is safe and effective in children who have had a kidney or heart transplants.

Who should not take Tacrolimus Capsules USP?

Do not take Tacrolimus Capsule USP if you are allergic to tacrolimus or any of the ingredients in Tacrolimus Capsule USP. See the end of this leaflet for a complete list of ingredients in Tacrolimus Capsule USP.

What should I tell my doctor before taking Tacrolimus Capsules USP?

Before you take Tacrolimus Capsules USP, 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 USP 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 can pass into your breast milk. You and your doctor should decide if you will take or breastfeed. You should not do both.

Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and heral 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 USP may affect the way other medicines work, and other medicines may affect how Tacrolimus Capsules USP 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 USP?

  • Take Tacrolimus Capsules USP exactly as your doctor tells you to take it.
  • Your doctor will tell you how many Tacrolimus Capsules USP to take and when to take them.
  • Your doctor may change your Tacrolimus Capsules USP dose if needed. Do not stop taking or change your dose of Tacrolimus Capsules USP without talking to your doctor.
  • Take Tacrolimus Capsules USP with or without food.
  • Take Tacrolimus Capsules USP the same way everyday. For example, if you choose to takeTacrolimus Capsules USP with food, you should always take Tacrolimus Capsules USP with food.
  • Take Tacrolimus Capsules USP 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 USP 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 USP.
  • If you take too much Tacrolimus Capsules USP, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Tacrolimus Capsules USP?

While you take Tacrolimus Capsules USP 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 USP?

Tacrolimus Capsules USP may cause serious side effects, including:

  • See “What the most important information I should know about Tacrolimus Capsules USP?”
  • high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take Tacrolimus Capsules USP. 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 USP.
  • nervous system problems. Call your doctor right away if you get any of these symptoms while taking Tacrolimus Capsules USP. These could be signs of a serious nervous system problem:
    • confusion
    • coma
    • muscle tremors
    • numbness and tingling
    • 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 USP.
  • high blood pressure. Your doctor will monitor your blood pressure while you take Tacrolimus Capsules USP.
  • heart problems (myocardial hypertrophy). Tell your doctor right away if you get any of these symptoms of heart problems while taking Tacrolimus Capsules USP:
    • shortness of breath
    • chest pain
    • feel lightheaded
    • feel faint

The most common side effects of Tacrolimus Capsules USP 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 USP 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 USP 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 USP. 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 USP?

  • Store Tacrolimus Capsules USP at 25°C (77°F); excursions permitted to 15ºC — 30ºC (59°F — 86ºF).
  • Safely throw away medicine that is out of date or no longer needed.

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

General information about the safe and effective use of Tacrolimus Capsules USP

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

How Does Tacrolimus Capsules USP 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 USP protects your new organ by slowing down the body’s immune system.

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

For more information, go to call Panacea Biotec Global Pharmacovigilance Function at 1-877-687-4130.

What are the ingredients in Tacrolimus Capsules USP?

Active ingredient: tacrolimus USP

Inactive ingredients: anhydrous lactose, hypromellose 2910, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and ferric oxide.

Manufactured by:
Panacea Biotec Ltd
Malpur, Baddi,
Distt. Solan (H.P.) – 173205, India

Mfg.Lic.No: MB/05/203

Distributed by:
Kremers Urban Pharmaceuticals Inc.
Princeton, NJ 08540, USA

Resource Number: L5778

Item Code: PPIT064DRevised Date: July 2015

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