Tacrolimus

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Tacrolimus

Longer graft survival

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  • For more information, please download leaflet.

    • The brand name of your medication is Suprotac® and the generic name is Tacrolimus (as monohydrate).
    • Suprotac® is an immunosuppressive drug. The immune system helps your body fight infections. The immune system can also reject a transplanted organ such as liver or kidney. This is because the immune system treats the new organ as an invader. Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
    • This medication is a capsule in dosage of 0.5,1 and 5 mg and available in two types of packaging: bottle or blister.
    • The bottle package contains 50 capsules inside a bottle and one bottle, along with a leaflet in a box.
    • The blister package contains 10 capsules in each blister and 5 blister along with a leaflet in a box.
    • Each capsule contains Tacrolimus as active pharmaceutical ingredient.

    1 Why is SUPROTAC® prescribed?

    SUPROTAC® is used to prophylaxis of transplant rejection in liver, kidney or heart with the other drugs.

    SUPROTAC® may be prescribed in other conditions which had not been mentioned here.

    2 How SUPROTAC® should be taken?

    • Take SUPROTAC® according to your doctor’s order. Your doctor will talk to you about amount and interval of using capsules.
    • SUPROTAC® is usually taken twice daily (every 12 hours) and at the same time each day. Your doctor may change the dose and frequency of use during treatment in order to be achieve the best therapeutic response
    • Take your medicine at the same time each day and avoid increasing or decreasing the dose of the drug without doctor’s order.
    • Take SUPROTAC® capsule immediately following removal from the bottle or blister.
    • Do not use SUPROTAC® more than the treatment period.
    • During treatment don’t change dosing form, strength, and the manufacturer of your medicine without consulting your doctor.
    • Avoid chewing, crushing or opening SUPROTAC® capsules.
    • Take the drug on an empty stomach, at least 1 hour before or 2 hours after a meal.
    • Follow the diet and exercise recommended by your doctor during taking medication.
    • If you have any more question about SUPROTAC® talk to your doctor, pharmacist or other health care providers.

    3 What special precautions should you follow during your treatment with SUPROTAC®?

    • Inform your doctor if you have hypertension, heart, kidney or liver problems.
    • Talk to your doctor or dentist before any surgery when you are using SUPROTAC®.
    • If you are pregnant or planning to have a baby consult your doctor about advantages and disadvantages of SUPROTAC® on embryos.
    • Talk with the doctor before starting any new drug, Keep a list of all your any prescription or nonprescription medicines, herbal preparation, and vitamins with you. Give this list to your doctor.
    • Stopping your treatment may increase the risk of rejection. Do not stop taking your medicine unless your doctor tells you to do so.
    • Due to the possibility of severe infections while using this drug, you should consider precautions.
    • If you need to have any vaccinations while you are using SUPROTAC®, inform your doctor. because co-administration of this drug with vaccines can increase the risk of infection or decrease efficacy of the vaccines.
    • Do not use SUPROTAC® at the same with antacids and cholestyramine, Take these medications at least two hours apart.
    • Use of SUPROTAC® may increase your sensitivity to the sun and raise up the possibility of sunburn. During treatment, avoid exposure to the sunlight and UV light and wear protective clothing and use sunscreen (SPF 30 or higher) also wear sun glasses when you are out.
    • Grapefruit and grapefruit juice have interaction with SUPROTAC® so avoid grapefruit and grapefruit juice while taking SUPROTAC®.
    • Avoid drinking alcohol while taking SUPROTAC®. It may increase your risk of side effects.
    • During treatment with SUPROTAC® try to avoid contact with people who have colds, flu or infections. If you notice any symptom of an infection call, your doctor immediately.
    • During treatment with SUPROTAC®, your doctor may run some tests to monitor Blood sugar, Potassium level in your blood or check kidney and liver function, so you may need to take some tests while using this product.
    • Taking SUPROTAC® may cause some problems in vision or nervous system function. Avoid driving or similar activities which may need high concentration.

    4 What are some side effects that you need to call your doctor about right away?

    • If you have used your medication more than prescribed;
    • If you see any symptoms of hypersensitivity reaction like skin rash, hives, itching, redness, swelling, blister, wheezing, difficulty in breathing or talking, roughness in voice, swelling in mouth, face, lips, tongue or throat;
    • If you notice any sign of infection like fever more than 38 C or higher, shivering, sever sore throat, pain in sinuses or ears, cough, increase or color change in sputum, pain in urination, mouth sores, any chronic wound, pain or itching in anus;
    • If you have symptoms of high blood pressure such as severe headache, blurred vision, pounding in your neck or ears, anxiety, and chest pain;
    • If you see any bruising, bleeding and or swelling of the body;
    • If you have symptoms of high blood sugar such as frequent urination, increased thirst, Loss of appetite, and fruity breath odor;
    • If you have symptoms like slow heart rate, muscle weakness, bone pain, jerky muscle movement, and slow reflexes.
    • If you have symptoms of stomach bleeding such as bloody or tarry stools, coughing up blood or dark vomiting
    • If you have urinary retention, urinary frequency, dysuria;
    • If you have severe headache
    • If you have symptoms of anemia such as shortness of breath, fatigue or severe sleepiness;
    • If you have signs of nerve disorder such as confusion, vision problems, tremor, numbness, seizures, and fainting;
    • If you hear a ringing sound in your ears or hearing loss;
    • If you have intense swelling, numbness or tingling in your hands and feet;
    • If you feel pain or swelling near your transplanted organ;
    • If you have skin rash;
    • If you feel change in your mental state, problems in speech or walking, decreased vision (may start gradually and get worse quickly);
    • In the event of symptoms that have not improved or worsened;

    5 What is the storage condition of SUPROTAC®?

    Store SUPROTAC® below 30°C and keep away from light and moisture.

    Keep the medicine out of the reach of children.

  • For more information, please download leaflet.

    • SUPROTAC® is available for oral administration as capsules (tacrolimus capsules) containing 0.5 mg, 1 mg and 5 mg of tacrolimus (as monohydrate).

    1 INDICATIONS AND USAGE

    1.1. Prophylaxis of Organ Rejection in Kidney Transplant

    TACROLIMUS is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that TACROLIMUS be used concomitantly with Azathioprine or Mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving TACROLIMUS capsules

    1.2. Prophylaxis of Organ Rejection in Liver Transplant

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

    1.3. Prophylaxis of Organ Rejection in Heart Transplant

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

    1.4. Limitations of Use

    TACROLIMUS capsules should not be used simultaneously with cyclosporine. Use with Sirolimus is not recommended in liver and heart transplant. The safety and efficacy of TACROLIMUS with Sirolimus has not been established in kidney transplant

    2 DOSAGE AND ADMINISTRATION

    2.1. Dosage in Adult Kidney, Liver, or Heart Transplant Patients

    The initial dose of TACROLIMUS should be administered no sooner than 6 hours after transplantation in the liver and heart transplant patients. In kidney transplant patients, the initial dose of TACROLIMUS may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered.

    2.2. Dosage in Pediatric Liver Transplant Patients

    Pediatric patients in general need higher tacrolimus doses compared to adults: the higher dose requirements may decrease as the child grows older.

    2.3. Dosage Adjustment in Patients with Renal Impairment

    Due to its potential for nephrotoxicity, consideration should be given to dosing TACROLIMUS at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required. In kidney transplant patients with post-operative oliguria, the initial dose of TACROLIMUS should be administered no sooner than 6 hours and within 24 hours of transplantation, but may be delayed until renal function shows evidence of recovery.

    2.4. Dosage Adjustments in Patients with Hepatic Impairment

    Due to the reduced clearance and prolonged half-life, patients with severe hepatic impairment (Child Pugh ≥ 10) may require lower doses of TACROLIMUS. Close monitoring of blood concentrations is warranted. The use of TACROLIMUS in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood concentrations of tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients.

    3 CONTRAINDICATIONS:

    TACROLIMUS capsules are contraindicated in patients with a hypersensitivity to tacrolimus or other macrolides. Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy

      Pregnancy Risk Factor: C

      There are no adequate and well-controlled studies in pregnant women. Tacrolimus is transferred across the placenta. The use of tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. TACROLIMUS should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.

      4.2. NURSING MOTHERS:

      Tacrolimus is excreted in human milk. As the effect of chronic exposure to tacrolimus in healthy infants is not established, patients maintained on tacrolimus should discontinue nursing taking into consideration importance of drug to the mother.

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