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Prograf

Prograf

(tacrolimus)

Prograf (Tacrolimus) belongs to the class of medications called immunosuppressants. It is used in addition to other medications to prevent the body's rejection of an allogeneic (from a donor) transplanted kidney, liver, or heart or treat the body's rejection of a transplanted kidney or liver.

Available form

Dosage

Capsule

0.5MG, 1MG, 5MG

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Prograf information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

For kidney, liver, or heart transplant patients, the dose of Prograf (Tacrolimus) varies according to the circumstances and will be determined by your doctor. If you are unable to take capsules, the medication may be delivered by slow injection into a vein at the hospital.

Prograf (Tacrolimus) is usually taken every 12 hours. You should try to take your doses of Prograf (Tacrolimus) at the same time every day. The doses should be spaced as evenly throughout the day as possible. Ask your transplant nurse or pharmacist about a dosing schedule that fits your lifestyle.

Prograf (Tacrolimus) may be taken with or without food, but it is best to be consistent. Prograf (Tacrolimus) should not be taken with grapefruit or grapefruit juice. The capsules should be swallowed whole and not cut, crushed, or chewed.

For the treatment of rheumatoid arthritis, the recommended adult dose of Prograf (Tacrolimus) is 3 mg, taken once a day. People taking Prograf (Tacrolimus) for rheumatoid arthritis must be regularly monitored by their doctor for side effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take Prograf (Tacrolimus) exactly as prescribed by the doctor. If even a few doses of Prograf (Tacrolimus) are missed, your body may reject your transplanted organ. If you miss a dose of Prograf (Tacrolimus), do not try to catch up on your own, but call your doctor or pharmacist immediately for advice. Ask your doctor ahead of time what you should do about missed doses. Be sure to order your medication refills well ahead of time.

Prograf (Tacrolimus) is often given with other medications. Make sure you talk to your doctor about whether you need to stop or continue taking any other immunosuppressive medications.

Store Prograf (Tacrolimus) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Prograf (Tacrolimus). If you are concerned about side effects, discuss the risks and benefits of Prograf (Tacrolimus) with your doctor.

The following side effects have been reported by at least 1% of people taking Prograf (Tacrolimus). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Constipation
back pain
changes in mood or emotions
Diarrhea
difficulty sleeping or nightmares
headache
loss of appetite
nausea
stomach pain
tiredness or fatigue
trembling
vomiting
weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

any mouth sores
cold or flu-like symptoms (such as Fever or sore throat)
fever
headache
high blood pressure
nightmares
pallor (paleness of skin)
palpitations (unusual heartbeats that may cause a pounding or fluttering feeling in the chest)
possible signs of cancer (e.g., a sore that does not heal; changes in bladder or bowel habits; lumps or thickened areas on the breast or other body areas; night sweats; severe, persistent Headaches; swollen glands; trouble swallowing, unexplained stomach upset, nagging cough or hoarseness; unusual bleeding or discharge)
rapid heartbeat
shortness of breath or difficulty breathing
signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
signs of progressive multifocal leukoencephalopathy (e.g., personality changes, progressive weakness on one side of the body, changes in memory, confusion)
signs of posterior encephalopathy syndrome (e.g., headache, seizures, visual disturbances, altered mental state)
signs of reduced red blood cells (e.g., fatigue, general feeling of being unwell, weakness, dizziness, fainting, pale skin, pale stool)
swelling or tingling in your hands or feet
symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

chest pain
convulsions (seizures)
signs of a hole in the digestive system (e.g., severe abdominal pain, burning pain, nausea, vomiting, chills or fever)
signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Prograf (Tacrolimus).

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Prograf (Tacrolimus).

Abnormal heart rhythms: Prograf (Tacrolimus) may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, Heart Attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how Prograf (Tacrolimus) may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of Prograf (Tacrolimus). Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Blood pressure: Prograf (Tacrolimus) treatment commonly causes mild-to-moderate increases in blood pressure. Monitor your blood pressure, and inform your doctor if there is an indication that your blood pressure is rising.

Diabetes: Prograf (Tacrolimus) may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Prograf (Tacrolimus). Your doctor will help to monitor this, but be sure to report any signs of high blood sugar (e.g., increased thirst, urination, unusual tiredness) to your doctor.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Prograf (Tacrolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Prograf (Tacrolimus), and whether any special monitoring is needed.

High potassium levels in the blood: Prograf (Tacrolimus) may cause an increase in potassium levels in the blood. Some foods (e.g., bananas or orange juice) and some medications may increase the risk of this problem. Be sure to tell your doctor and pharmacist about all the medications you are taking (including non-prescription medications) and to talk to them about potassium-rich foods.

Infections: Prograf (Tacrolimus) reduces resistance to infections and may delay healing. Ensure proper treatment to avoid infection (e.g., dental work, skin injury). Avoid activities that increase the risk of infection.

Because Prograf (Tacrolimus) reduces the body’s response to infection, conditions caused by bacteria or viruses that have been dormant in the body, such as chicken pox, hepatitis B, or Tuberculosis may be reactivated.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

Kidneys: Prograf (Tacrolimus) may affect kidney function. Your doctor will monitor your kidney function with laboratory tests while you are taking Prograf (Tacrolimus). Be sure to immediately report to your doctor any evidence of changes in kidney function such as changes in the appearance of urine, frequency of urination, and amount of urine produced.

Liver function: Liver disease or reduced liver function may cause Prograf (Tacrolimus) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Prograf (Tacrolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Prograf (Tacrolimus), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Prograf (Tacrolimus).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lymphoma and other malignancies: People taking immunosuppressant medications, such as Prograf (Tacrolimus), are at increased risk of developing a type of cancer known as lymphoma and certain types of Skin Cancer. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than to one specific medication.

Possible warning signs of cancer include a change in bowel or bladder habits, sores that don’t heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough or persistent and severe headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.

Nerves: Prograf (Tacrolimus) may affect nerve function and cause symptoms such as tremors and headaches. Be sure to report any changes to your doctor at once.

Red blood cell aplasia: Prograf (Tacrolimus) has been reported to cause the body to stop producing red blood cells. If you experience symptoms of reduced red blood cell count such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that can occur when using Prograf (Tacrolimus). Make sure your doctor knows if you have experienced this condition before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Pregnancy: Adequate studies have not been conducted on the use of Prograf (Tacrolimus) by pregnant women. Reports of the use of Prograf (Tacrolimus) during pregnancy has been associated with high blood potassium levels and kidney problems in the newborn.

Prograf (Tacrolimus) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Prograf (Tacrolimus), contact your doctor immediately.

Breast-feeding: Prograf (Tacrolimus) passes into breast milk. Breast-feeding is not recommended while taking Prograf (Tacrolimus). If you are a breast-feeding mother and taking Prograf (Tacrolimus), it may affect your baby. Talk to your doctor.

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