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Gengraf Capsules and Ketoconazole (Systemic)

Determining the interaction of Gengraf Capsules and Ketoconazole (Systemic) and the possibility of their joint administration.

Check result:

Gengraf Capsules <> Ketoconazole (Systemic)

Relevance: 22.08.2022 Reviewer: Shkutko P.M., M.D., in

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.

Consumer:

Ketoconazole may increase the blood levels and effects of cycloSPORINE. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. Contact your doctor if your condition changes or you experience increased side effects such as nausea, vomiting, diarrhea, abdominal pain, dizziness, fatigue, headache, tremors, seizures, fever, sore throat, unusual bruising or bleeding, and increased or decreased urination. 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.

Professional:

ADJUST DOSE: Certain azole antifungal agents such as ketoconazole and itraconazole that are potent inhibitors of CYP450 3A4 may significantly increase the blood levels of cyclosporine, which is primarily metabolized by the isoenzyme. The risk of nephro- and neurotoxicity associated with cyclosporine may be increased. Five- to tenfold increases in cyclosporine levels have been reported during coadministration with ketoconazole.

MANAGEMENT: Cyclosporine dosage reductions are often necessary during coadministration with azole antifungal agents. Cyclosporine blood levels and renal function should be checked frequently and the dosage adjusted accordingly, particularly following initiation or discontinuation of antifungal therapy in patients who are stabilized on their cyclosporine regimen. A 60% to 80% reduction may be necessary during concomitant therapy with ketoconazole. Patients should be advised to notify their doctor if they experience possible signs of cyclosporine toxicity such as nausea, vomiting, diarrhea, abdominal pain, dizziness, fatigue, headache, tremors, and convulsions.

References

Sobh M, Elagroudy A, Moustafa F, Harras F, Elbedewy M, Ghoneim M "Coadministration of ketoconazole to cyclosporin-treated kidney transplant recipients: a prospective randomized study." Am J Nephrol 15 (1995): 493-9
Charles BG, Ravenscroft PJ, Rigby RJ "The ketoconazole-cyclosporin interaction in an elderly renal transplant patient." Aust N Z J Med 19 (1989): 292-3
Gerntholtz T, Pascoe MD, Botha JF, Halkett J, Kahn D "The use of a cyclosporin-ketoconazole combination: making renal transplantation affordable in developing countries." Eur J Clin Pharmacol (2004):
Hwang WL, Gau JP, Young JH, Chia LG "Ketoconazole and high-dose methylprednisolone predisposing to cyclosporine-induced seizures: report of 3 cases." Acta Haematol 88 (1992): 139-41
Kiss D, Thiel G "Glucose-intolerance and prolonged renal-transplant insufficiency due to ketoconazole-cyclosporin A interaction." Clin Nephrol 33 (1990): 207-8
Sorenson AL, Lovdahl M, Hewitt JM, et al. "Effects of ketoconazole on cyclosporine metabolism in renal allograft recipients." Transplant Proc 26 (1994): 2822
Horton CM, Freeman CD, Nolan PE Jr, Copeland JG 3rd "Cyclosporine interactions with miconazole and other azole- antimycotics: a case report and review of the literature." J Heart Lung Transplant 11 (1992): 1127-32
Keogh A, Spratt P, McCosker C, Macdonald, Mundy J, Kaan A "Ketoconazole to reduce the need for cyclosporine after cardiac transplantation." N Engl J Med 333 (1995): 628-33
First MR, Schroeder TJ, Alexander JW, et al "Cyclosporine dose reduction by ketoconazole administration in renal transplant recipients." Transplantation 51 (1991): 365-70
Yee GC, McGuire TR "Pharmacokinetic drug interactions with cyclosporin (Part I)." Clin Pharmacokinet 19 (1990): 319-32
Kramer MR, Marshall SE, Denning DW, et al "Cyclosporine and itraconazole interaction in heart and lung transplant recipients." Ann Intern Med 113 (1990): 327-9

Gengraf Capsules

Generic Name: cyclosporine

Brand name: Gengraf, Neoral, Sandimmune, Sandimmune

Synonyms: Gengraf (Capsules, Modified), Gengraf

What is Gengraf Capsules?

Ketoconazole (Systemic)

Generic Name: ketoconazole

Brand name: Nizoral

Synonyms: Ketoconazole

What is Ketoconazole (Systemic)?

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In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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