PCE Dispertab and Prograf (Tacrolimus Granules for Suspension)

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Erythromycin may significantly increase the blood levels of tacrolimus. This may increase the risk of serious side effects such as kidney problems, diabetes, nervous system disorders, hyperkalemia (high potassium levels in the blood), high blood pressure, irregular heart rhythm, heart failure, infections, and various types of malignancies including lymphoma and skin cancer. You may need a dose adjustment if you have been taking tacrolimus and are starting treatment with erythromycin. Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the interaction, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. Contact your doctor if you develop signs and symptoms of infection such as fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in phlegm, weight loss, red or inflamed skin, body sores, and pain or burning during urination. Also seek medical attention if you experience frequent urination, increased hunger or thirst, loss of appetite, confusion, tremor, numbness or tingling, seizures, vision changes, sudden dizziness, lightheadedness, fainting, shortness of breath, heart palpitations, and chest pain. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

ADJUST DOSE: Coadministration with certain macrolide or ketolide antibiotics may significantly increase the oral bioavailability of tacrolimus. The proposed mechanism is inhibition of tacrolimus metabolism via intestinal CYP450 3A4. Inhibition of P-glycoprotein (P-gp) efflux transporter in gut wall may also contribute. There have been case reports of nephrotoxicity and other adverse effects (e.g., hyperkalemia, hyperglycemia, hemolytic anemia, hemolytic uremic syndrome, neurotoxicity) in association with significantly elevated tacrolimus blood levels within days following the addition of clarithromycin or erythromycin, which necessitated either a dosing adjustment or interruption of tacrolimus and/or discontinuation of the macrolide. Greater than 10-fold increases in tacrolimus blood levels have been observed in some cases. These reports are consistent with data derived from pharmacokinetic studies involving tacrolimus and other potent CYP450 3A4 inhibitors such as azole antifungal agents. Although data are not available for telithromycin, it is expected to interact similarly with tacrolimus due to its status as a potent CYP450 3A4/P-gp inhibitor.

MONITOR CLOSELY: Tacrolimus can cause concentration-dependent prolongation of the QT interval. Theoretically, coadministration with other agents that can prolong the QT interval such as macrolide and ketolide antibiotics may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

MANAGEMENT: Caution is advised when tacrolimus is used with macrolide or ketolide antibiotics that significantly inhibit CYP450 3A4 such as clarithromycin, erythromycin, josamycin, and telithromycin. A preemptive dosage reduction for tacrolimus may be appropriate in some cases. Frequent monitoring of tacrolimus whole blood levels should be performed during and after discontinuation of macrolide antibiotic therapy, and the tacrolimus dosage adjusted accordingly. In addition, patients should be closely monitored for development of serious adverse effects such as nephrotoxicity, lymphoma and other malignancies, infections, diabetes, neurotoxicity (tremor, paraesthesia, encephalopathy, delirium, coma), hyperkalemia, QT prolongation, myocardial hypertrophy, and hypertension. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

PCE Dispertab

Generic Name: erythromycin

Brand name: EES. Granules, EES-400 Filmtab, EryPed 200, EryPed 400, Ery-Tab, Erythrocin Lactobionate, Erythrocin Stearate Filmtab, PCE Dispertab, E. E. S, EryPed, Erythrocin, Erythromycin Filmtabs, Erythromycin Lactobionate - IV

Synonyms: PCE Dispertab (Oral), PCE, PCE (Oral)

What is PCE Dispertab?

Prograf (Tacrolimus Granules for Suspension)

Generic Name: tacrolimus

Brand name: Prograf, Astagraf XL, Envarsus XR, Hecoria

Synonyms: Prograf

What is Prograf (Tacrolimus Granules for Suspension)?