Generic Prograf (Tacrolimus)

Common use

Prograf suppresses immune system and is used to prevent organ rejection after transplantation of heart, kidney, small bowel, bone marrow. Its active component is anhydrous tacrolimus. The drug binds to cytosolic protein (FKBP 12) and inhibits calcineurin hereby suppressing T-cell dependent immune response of the organism, formation of cytotoxic lymphocytes, proliferation of B cells depending on T-helpers, and formation of interleukin-2, -3 and γ-interferon.



Dosage and direction

The daily dose of Prograf should be divided in two intakes separated by twelve hours. The capsules should be taken immediately after taking them out from the blister packs with full glass of water on an empty stomach, or at least one hour before or 2-3 hours after a meal. Fatty food decreases absorption of the medication. Correction of the dose is needed inpatients with serious liver impairment.



Precautions

Risk of caner and especially skin cancer and infectious diseases increases due to immune suppressing effect of Prograf. Avoid exposing yourself to direct sun rays. Blood cell count, kidney and liver unction should be monitored on a regular basis while taking this medication. Diabetes may develop especially in Hispanic or African-American patients. Do not take the medicine with a grapefruit juice. This medication can appear in breast milk and transfer through placenta which can be harmful to a baby. Breastfeeding should be stopped while on Prograf. Inform your doctor if you have kidney or liver diseases, high blood pressure, or if you have taken cyclosporine (Neoral, Sandimmune, Gengraf) within the day before.



Contraindications

The preparation cannot be administered in patients hypersensitive to tacrolimus, other macrolides, or or hydrogenated castor oil.



Possible side effect

Side effects of Prograf are numerous and include arterial hypertension, hypotension, angina, stroke, tachycardia, arrhythmia, diarrhea, nausea, vomiting, abdominal pain, change of liver transaminases activity, constipation, anemia, easy bruising and bleeding, changes in clotting, kidney disorders and failure, hyperglycemia, hyperpotessemia, diabetes, seizures, pain in joints, miastenia, tremor, headache, vision changes, dizziness, depression, mental confusion, hallucinations, difficulty breathing, allergy, achne, photosensitivity, high risk of tumor formation, high body temperature, swelling of extremities, baldness. In case of bothersome and serious side effects seek immediate medical attention.



Drug interaction

Prograf may slow down metabolism of Cyclosporine (Neoral, Sandimmune, Gengraf) thus increasing its toxicity. As Prograf is metabolized by cytochrome CYP 3A4, a concomitant use of medications affecting or being metabolized by this cytochrome may change Prograf levels in the blood (for example testosterone, cortisone). Tacrolimus binds to proteins of blood serum and and may change (mutually) effects of the medications with high affinity to serum proteins such as peroral anticoagulants, diabetic drugs or NSAIDs. Concomitant use of Prograf with neurotoxic or nephrotoxic medication may increase toxicity (aminoglycosides, inhibitors of DNA gyrase, vancomycin, co-trimoxazole, NSAIDs, ganciclovir or acyclovir). Avoid co-administration of Prograf with potassium-saving diuretics of medicines which contain potassium to avoid hyperpotassemia (Dyazide, Maxzide, amiloride, Moduretic, and spironolactone, Aldactone). Effects of vaccination may be decreased and use of live attenuated vaccines should be avoided. Inform your doctor about all drugs and herbal products you are taking.



Missed dose

Never take a double dose of this medication. If it is almost time of the next dose just skip the missed portion and continue to take the medicine according to the schedule.



Overdose

In cases of accidental Prograf overdose the following symptoms were described: tremor, headache, nausea, vomiting, infection, rash, lethargy, increased urea nitrogen in blood and increased serum concentrations of creatinine and alanine transaminase (ALT).



Storage

Prograf should be stored at room temperature between 15-30 C (59-86 F).



Disclaimer

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