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Ketek (telithromycin) Disease Interactions

There are 7 disease interactions with Ketek (telithromycin):

Major

Antibiotics (applies to Ketek) colitis

Major Potential Hazard, Moderate plausibility. Applicable conditions: Colitis/Enteritis (Noninfectious)

Clostridioides difficile-associated diarrhea (CDAD), formerly pseudomembranous colitis, has been reported with almost all antibacterial drugs and may range from mild diarrhea to fatal colitis. The most common culprits include clindamycin and lincomycin. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C difficile, whose toxins A and B contribute to CDAD development. Morbidity and mortality are increased with hypertoxin-producing strains of C difficile; these infections can be resistant to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea after antibacterial use. Since CDAD has been reported to occur more than 2 months after antibacterial use, careful medical history is necessary. Therapy with broad-spectrum antibacterials and other agents with significant antibacterial activity should be administered cautiously in patients with history of gastrointestinal disease, particularly colitis; pseudomembranous colitis (generally characterized by severe, persistent diarrhea and severe abdominal cramps, and sometimes associated with the passage of blood and mucus), if it occurs, may be more severe in these patients and may be associated with flares in underlying disease activity. Antibacterial drugs not directed against C difficile may need to be stopped if CDAD is suspected or confirmed. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and surgical evaluation should be started as clinically indicated.

References

  1. Moriarty HJ, Scobie BA "Pseudomembranous colitis in a patient on rifampicin and ethambutol." N Z Med J 04/23/80 (1980): 294-5
  2. Thomas E, Mehta JB "Pseudomembranous colitis due to oxacillin therapy." South Med J 77 (1984): 532-3
  3. Bauwens JE, McFarland LV, Melcher SA "Recurrent clostridium difficile disease following ciprofloxacin use." Ann Pharmacother 31 (1997): 1090
  4. Davies J, Beck E "Recurrent colitis following antibiotic-associated pseudomembranous colitis." Postgrad Med J 57 (1981): 599-601
  5. Dan M, Samra Z "Clostridium difficile colitis associated with ofloxacin therapy." Am J Med 87 (1989): 479
  6. Harmon T, Burkhart G, Applebaum H "Perforated pseudomembranous colitis in the breast-fed infant." J Pediatr Surg 27 (1992): 744-6
  7. Milstone EB, McDonald AJ, Scholhamer CF Jr "Pseudomembranous colitis after topical application of clindamycin." Arch Dermatol 117 (1981): 154-5
  8. Cone JB, Wetzel W "Toxic megacolon secondary to pseudomembranous colitis." Dis Colon Rectum 25 (1982): 478-82
  9. Burt RA "A review of the drug events reported by 12,917 patients treated with cephalexin." Postgrad Med J 59 (1983): 47-50,51-3
  10. Cannon SR, Dyson PH, Sanderson PJ "Pseudomembranous colitis associated with antibiotic prophylaxis in orthopaedic surgery." J Bone Joint Surg Br 70-B (1988): 600-2
  11. Miller DL, Sedlack JD, Holt RW "Perforation complicating rifampin-associated pseudomembranous enteritis." Arch Surg 124 (1989): 1082
  12. Wang C, Calandra GB, Aziz MA, Brown KR "Efficacy and safety of imipenem/cilastatin: a review of worldwide clinical experience." Rev Infect Dis 7 (1985): s528-36
  13. Miller SN, Ringler RP "Vancomycin-induced pseudomembranous colitis." J Clin Gastroenterol 9 (1987): 114-5
  14. Bernstein L "Adverse reaction to trimethoprim-sulfamethoxazole, with particular reference to long-term therapy." Can Med Assoc J 112 (1975): s96-8
  15. Calandra GB, Brown KR, Grad LC, et al "Review of adverse experiences and tolerability in the first 2,516 patients treated with imipenem/cilastatin." Am J Med 78 (1985): 73-8
  16. Pokorney BH, Nichols TW, Jr "Pseudomembranous colitis. A complication of sulfasalazine therapy in a patient with Crohn's colitis." Am J Gastroenterol 76 (1981): 374-6
  17. Sankarankutty M, McGeorge D, Galasko CS "Pseudomembranous colitis following cephradine prophylaxis." Postgrad Med J 58 (1982): 726-8
  18. Van Ness MM, Cattau EL Jr "Fulminant colitis complicating antibiotic-associated pseudomembranous colitis: case report and review of the clinical manifestations and treatment." Am J Gastroenterol 82 (1987): 374-7
  19. Hutcheon DF, Milligan FD, Yardley JH, Hendrix TR "Cephalosporin-associated pseudomembranous colitis." Am J Dig Dis 23 (1978): 321-6
  20. Gordin F, Gibert C, Schmidt ME "Clostridium difficile colitis associated with trimethoprim-sulfamethoxazole given as prophylaxis for pneumocystis carinii pneumonia." Am J Med 96 (1994): 94-5
  21. Bingley PJ, Harding GM "Clostridium difficile colitis following treatment with metronidazole and vancomycin." Postgrad Med J 63 (1987): 993-4
  22. Hinton NA "The effect of oral tetracycline HCl and doxycycline on the intestinal flora." Curr Ther Res Clin Exp 12 (1970): 341-52
  23. Ring FA, Hershfield NB, Machin GA, Scott RB "Sulfasalazine-induced colitis complicating idiopathic ulcerative colitis." Can Med Assoc J 131 (1984): 43-5
  24. Saginur R, Hawley CR, Bartlett JG "Colitis associated with metronidazole therapy." J Infect Dis 141 (1980): 772-4
  25. Friedman RJ, Mayer IE, Galambos JT, Hersh T "Oxacillin-induced pseudomembranous colitis." Am J Gastroenterol 73 (1980): 445-7
  26. "Multum Information Services, Inc. Expert Review Panel"
  27. Midtvedt T, Carlstedt-Duke B, Hoverstad T, et al "Influence of peroral antibiotics upon the biotransformatory activity of the intestinal microflora in healthy subjects." Eur J Clin Invest 16 (1986): 11-7
  28. Leigh DA, Simmons K, Williams S "Gastrointestinal side effects following clindamycin and lincomycin treatment: a follow up study." J Antimicrob Chemother 6 (1980): 639-45
  29. Altamirano A, Bondani A "Adverse reactions to furazolidone and other drugs. A comparative review." Scand J Gastroenterol Suppl 169 (1989): 70-80
  30. Hecht JR, Olinger EJ "Clostridium difficile colitis secondary to intravenous vancomycin." Dig Dis Sci 34 (1989): 148-9
  31. Brause BD, Romankiewicz JA, Gotz V, Franklin JE Jr, Roberts RB "Comparative study of diarrhea associated with clindamycin and ampicillin therapy." Am J Gastroenterol 73 (1980): 244-8
  32. Boriello SP, Jones RH, Phillips I "Rifampicin-associated pseudomembranous colitis." Br Med J 281 (1980): 1180-1
  33. Klinger D, Radford P, Collin J "Pneumoperitoneum without faecal peritonitis in a patient with pseudomembranous colitis." Br Med J 288 (1984): 1271-2
  34. Saadah HA "Carbenicillin and pseudomembranous enterocolitis." Ann Intern Med 93 (1980): 645
  35. Lyon JA "Imipenem/cilastatin: the first carbapenem antibiotic." Drug Intell Clin Pharm 19 (1985): 894-8
  36. Daly JJ, Chowdary KV "Pseudomembranous colitis secondary to metronidazole." Dig Dis Sci 28 (1983): 573-4
  37. Trexler MF, Fraser TG, Jones MP "Fulminant pseudomembranous colitis caused by clindamycin phosphate vaginal cream." Am J Gastroenterol 92 (1997): 2112-3
  38. Edlund C, Brismar B, Nord CE "Effect of lomefloxacin on the normal oral and intestinal microflora." Eur J Clin Microbiol Infect Dis 1 (1990): 35-9
  39. O'Meara TF, Simmons RA "Carbenicillin and pseudomembranous enterocolitis." Ann Intern Med 92 (1980): 440-1
  40. Meadowcroft AM, Diaz PR, Latham GS "Clostridium difficile toxin-induced colitis after use of clindmycin phosphate vaginal cream." Ann Pharmacother 32 (1998): 309-11
  41. Ehrenpreis ED, Lievens MW, Craig RM "Clostridium difficile-associated diarrhea after norfloxacin." J Clin Gastroenterol 12 (1990): 188-9
  42. Osler T, Lott D, Bordley J, et al "Cefazolin-induced pseudomembranous colitis resulting in perforation of the sigmoid colon." Dis Colon Rectum 29 (1986): 140-3
  43. Parry MF, Rha CK "Pseudomembranous colitis caused by topical clindamycin phosphate." Arch Dermatol 122 (1986): 583-4
  44. Clissold SP, Todd PA, Campoli-Richards DM "Imipenem/cilastatin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic efficacy." Drugs 33 (1987): 185-241
  45. Sugarman B "Trimethoprim-sulfamethoxazole, pseudomembranous colitis, and spinal cord injury." South Med J 78 (1985): 711-3
  46. Golledge CL, Riley TV "Clostridium difficile-associated diarrhoea after doxycycline malaria prophylaxis." Lancet 345 (1995): 1377-8
  47. Edlund C, Lidbeck A, Kager L, Nord CE "Effect of enoxacin on colonic microflora of healthy volunteers." Eur J Clin Microbiol 6 (1987): 298-300
View all 47 references
Major

Telithromycin (applies to Ketek) hepatitis

Major Potential Hazard, Moderate plausibility. Applicable conditions: Autoimmune Hepatitis

The use of telithromycin is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of any macrolide antibacterial agent.

Major

Telithromycin (applies to Ketek) liver disease

Major Potential Hazard, Moderate plausibility. Applicable conditions: Alcoholism

Hepatic dysfunction, including elevated liver enzymes and hepatitis, with or without jaundice, has been reported with the use of telithromycin. Although these events are generally reversible, liver failure resulting in transplantation or death has been reported rarely during postmarketing use. Alcohol use may have been a contributing factor in some of the severe cases. Therapy with telithromycin should preferably be avoided in patients with alcoholism, liver disease, or a prior history of hepatitis/jaundice associated with use of the drug. Patients treated with telithromycin should be instructed to discontinue the drug and seek medical attention promptly if signs and symptoms of hepatic injury develop such as fever, pruritus, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, and jaundice.

The pharmacokinetics of telithromycin is not significantly altered in the presence of hepatic impairment due to a compensatory increase in renal elimination. No dosage adjustment is necessary unless renal function is also severely impaired (CrCl < 30 mL/min).

References

  1. Cantalloube C, Bhargava V, Sultan E, Vacheron F, Batista I, Montay G "Pharmacokinetics of the ketolide telithromycin after single and repeated doses in patients with hepatic impairment." Int J Antimicrob Agents 22 (2003): 112-21
  2. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
  3. Clay KD, Hanson JS, Pope SD, Rissmiller RW, Purdum PP 3rd, Banks PM "Brief communication: severe hepatotoxicity of telithromycin: three case reports and literature review." Ann Intern Med 144 (2006): E1-E6
Major

Telithromycin (applies to Ketek) myasthenia gravis

Major Potential Hazard, High plausibility.

Telithromycin has been reported to exacerbate myasthenia gravis. Case reports suggest that it can occur even within a few hours after the first dose. Life-threatening acute respiratory failure with a rapid onset has occurred in patients with myasthenia gravis receiving telithromycin for respiratory tract infections. Therapy with telithromycin is not recommended in patients with myasthenia gravis unless no other therapeutic alternatives are available. If telithromycin is prescribed, patients must be closely monitored and advised to immediately discontinue the drug and seek medical attention if they experience exacerbation of their symptoms. Supportive measures should be instituted as medically necessary.

References

  1. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
  2. Nieman RB, Sharma K, Edelberg H, Caffe SE "Telithromycin and myasthenia gravis." Clin Infect Dis 37 (2003): 1579
Major

Telithromycin (applies to Ketek) QT interval prolongation

Major Potential Hazard, Moderate plausibility. Applicable conditions: Abnormal Electrocardiogram, Arrhythmias, Electrolyte Abnormalities, Hypokalemia, Magnesium Imbalance

Telithromycin may prolong the QTc interval of the electrocardiogram in some patients. QTC prolongation has been associated with an increased risk of ventricular arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsade de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in nearly 5000 patients in clinical efficacy trials, including 204 patients who had a prolonged QTc interval at baseline. In addition, a pharmacokinetic study found no significant QT prolongation in 34 healthy volunteers at all heart rates tested following telithromycin administered as repeated doses of 800 mg or as single doses of up to 2400 mg. Nevertheless, therapy with telithromycin should be avoided in patients with preexisting arrhythmia or congenital prolongation of the QTc interval. It should also be avoided in the presence of proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia; clinically significant bradycardia; or concomitant use of class IA or III antiarrhythmic drugs or other medications that are known to produce an increase in the QTc interval.

References

  1. Owens RC "QT Prolongation with Antimicrobial Agents : Understanding the Significance." Drugs 64 (2004): 1091-124
  2. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
  3. Iannini PB "Cardiotoxicity of macrolides, ketolides and fluoroquinolones that prolong the QTc interval." Expert Opin Drug Saf 1 (2002): 121-8
  4. Demolis JL, Vacheron F, Cardus S, Funck-Brentano C "Effect of single and repeated oral doses of telithromycin on cardiac QT interval in healthy subjects." Clin Pharmacol Ther 73 (2003): 242-52
View all 4 references
Moderate

Telithromycin (applies to Ketek) hemodialysis

Moderate Potential Hazard, High plausibility.

The effect of hemodialysis on removing telithromycin from the body has not been studied. Doses should be given after the dialysis session on dialysis days.

References

  1. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
Moderate

Telithromycin (applies to Ketek) renal dysfunction

Moderate Potential Hazard, High plausibility.

Telithromycin is eliminated by both renal and hepatic routes. In a multiple-dose study of subjects with varying degrees of renal impairment, patients classified as having severely impaired renal function (CrCl < 30 mL/min) had a 1.4-fold increase in steady-state peak plasma concentration (Cmax) and a 1.9-fold increase in systemic exposure (AUC) of telithromycin compared to healthy volunteers following administration of 800 mg once daily for 5 days. Renal excretion may serve as a compensatory elimination pathway for telithromycin in situations where metabolic clearance is impaired. In one study, coadministration of ketoconazole (which inhibits metabolism of telithromycin via CYP450 3A4) in 2 patients with severe renal impairment resulted in a 4- to 5-fold increase in telithromycin AUC compared to that in healthy subjects with normal renal function receiving telithromycin alone. Since patients with severe renal impairment are prone to conditions that may impair their metabolic clearance, telithromycin dosage should be reduced to 600 mg once daily in patients with severe renal impairment (CrCl < 30 mL/min), including those undergoing dialysis. The dosage should be further reduced to 400 mg once daily if there is coexisting hepatic impairment.

References

  1. "Product Information. Ketek (telithromycin)." Aventis Pharmaceuticals, Bridgewater, NJ.
  2. Shi J, Montay G, Chapel S, et al. "Pharmacokinetics and safety of the ketolide telithromycin in patients with renal impairment." J Clin Pharmacol 44 (2004): 234-44

Ketek (telithromycin) drug interactions

There are 578 drug interactions with Ketek (telithromycin)

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.