This includes prescription and over-the-counter medicines, Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prograf only for the indication prescribed.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Copyright 1996-2020 Cerner Multum, Inc. To date, no other relevant epidemiological data are available. All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medications associated with PRCA.As Prograf contains lactose, special care should be taken in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.The printing ink used to mark Prograf capsules 0.5 mg and 1mg contains soya lecithin.

In rats, tacrolimus caused toxic effects to the nervous system and the eyes. 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. Therapeutic drug monitoring of mycophenolic acid may be appropriate when switching from ciclosporin to tacrolimus or vice versa.Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole + trimethoprim, NSAIDs, ganciclovir or aciclovir).Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective. liver, kidney, heart), your body’s immune system will try to reject the new organ.

Decreases in AUC (27%) and CIn a study of stable renal transplant patients who were administered Prograf immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced. Blood trough levels of tacrolimus should also be monitored following dose adjustment, changes in the immunosuppressive regimen, or following co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml. Corresponding data based on whole blood averaged 47.6 l.Tacrolimus is a low-clearance substance. If signs of toxicity are noted (e.g. If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.Prograf can be administered intravenously or orally. As Prograf is a medicinal product with low clearance, adjustments to the dosage regimen may take several days before changes in blood levels are apparent.

The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects). Excipient with known effect: 62.85 mg of lactose monohydrate Each capsule contains less than 1 mmol sodium (23 mg). Before using this medicine, tell your doctor about all other medicines you use. Call your doctor for medical advice about side effects. This approach was reserved for patients without organ dysfunction (e.g. In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids. This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus. Some cases have reported resolution on switching to alternative immunosuppression. Prograf … 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. morning and evening). If you require BNF for Children, use BNFC. Subsequently, during maintenance therapy, blood concentrations have generally been in the range of 5 - 15 ng/ml in liver, kidney and heart transplant recipients.

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