Possible interactions with other medicinal products known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).Other potential interactions that may increase systemic exposure of tacrolimus include the prokinetic agent metoclopramide, cimetidine and magnesium-aluminium-hydroxide.Clinically the following substances have been shown to decrease tacrolimus blood levels:Strong interactions have been observed with rifampicin, phenytoin or St. John's Wort (High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly. However, cases of spontaneous abortion have been reported. ritonavir, nelfinavir, saquinavir), HCV protease inhibitors (e.g.
Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). Patients switched to Prograf therapy should not receive anti-lymphocyte treatment concomitantly. However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output). Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions. PVC/PVDC/Aluminium blisters or PVC/PVDC/Aluminium perforated unit-dose blisters. Do not save this mixture for later use. renal dysfunction). To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.Hypersensitivity to tacrolimus or other macrolides.Hypersensitivity to any of the excipients listed in section 6.1. The use of live attenuated vaccines should be avoided.Gastrointestinal perforation has been reported in patients treated with tacrolimus. Ask your doctor or pharmacist if you do not understand these instructions.Prograf oral granules must be mixed with water right before you take them. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.You may get infections more easily, even serious or fatal infections. Prograf is a prescription medicine and is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant. Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient.As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood including a semi-automated microparticle enzyme immunoassay (MEIA). Subsequently, during maintenance therapy, blood concentrations have generally been in the range of 5 - 15 ng/ml in liver, kidney and heart transplant recipients. These symptoms may start gradually and get worse quickly.Prograf can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys.
Efficacy results of the largest studies in each indication are summarised below. If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.Prograf can be administered intravenously or orally.
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