Telithromycin

Class: Ketolides
VA Class: AM200
Chemical Name: Erythromycin, 3de[(2,6 - dideoxy - 3 - C - methyl - 3 - O - methyl - α - L - ribo - hexopyranosyn)] - 11,12 - dideoxy - 6 - O - methyl - 3 - oxo - 12,11 - [oxy - carbonyl{[4 - [4 - (3 - pyridinyl) - 1H - imidazol - 1 - yl]butyl]imino}]
Molecular Formula: C₄₃H₆₅N₅O₁₀
CAS Number: 173838-31-8
Brands: Ketek

• 
  

  Contraindicated in patients with myasthenia gravis.¹ Fatal or life-threatening acute respiratory failure reported.¹ (See Myasthenia Gravis Patients under Cautions.)

  
  

REMS:

FDA approved a REMS for telithromycin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; ketolide.^{1 14 23}

Uses for Telithromycin

Respiratory Tract Infections

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae (Chlamydia pneumoniae), or Mycoplasma pneumoniae.^{1 2 3 4 5}

Although initially approved by FDA for treatment of acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and CAP in 2004,³² approval for treatment of acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis was withdrawn in 2007 because of safety concerns.³⁴

Telithromycin Dosage and Administration

Administration

Oral Administration

Administer orally once daily without regard to meals.¹

Dosage

Adults

Respiratory Tract Infections

Community-acquired Pneumonia

Oral

800 mg once daily for 7–10 days.¹

Special Populations

Hepatic Impairment

Hepatic impairment: Dosage adjustment not required.^{1 14 15} (See Hepatic Effects under Cautions.)

Hepatic impairment with coexisting severe renal impairment (Cl_cr <30 mL/minute or undergoing hemodialysis): Use reduced dosage of 400 mg once daily.¹ (See Hepatic Effects under Cautions.)

Renal Impairment

Mild to moderate renal impairment: Dosage adjustment not required.^{2 14 16}

Severe renal impairment (Cl_cr <30 mL/minute or undergoing hemodialysis): Use reduced dosage of 600 mg once daily.¹ On dialysis days, administer daily dose after dialysis session.¹

Severe renal impairment (Cl_cr <30 mL/minute or undergoing hemodialysis) with coexisting hepatic impairment: Use reduced dosage of 400 mg once daily.¹ (See Hepatic Effects under Cautions.)

Geriatric Patients

Routine dosage adjustment based on age not required.¹

Cautions for Telithromycin

Contraindications

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  Myasthenia gravis.¹ (See Myasthenia Gravis Patients under Cautions.)

  
  


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  Known hypersensitivity to telithromycin, any macrolide, or any ingredient in the formulation.¹

  
  


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  History of hepatitis and/or jaundice associated with use of telithromycin or any macrolide.¹

  
  


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  Concomitant use with cisapride or pimozide.¹ (See Specific Drugs and Foods under Interactions.)

  
  

Warnings/Precautions

Warnings

Myasthenia Gravis Patients

Exacerbation of myasthenia gravis reported.^{1 29 30 31} Exacerbations have occurred within a few hours of the first dose and have included rapid-onset, fatal or life-threatening, acute respiratory failure.^{1 29 30 31} (See Contraindications under Cautions.)

Hepatic Effects

Acute hepatic failure and severe liver injury (in some cases fatal) reported.^{1 24} Reactions include fulminant hepatitis and hepatic necrosis requiring liver transplant.¹ Liver injury may progress rapidly and occur after administration of a few doses.¹

Monitor closely for signs and symptoms of hepatic impairment (i.e., fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness, hepatomegaly).¹ Advise patients to immediately discontinue the drug and contact their clinician if they experience signs and symptoms of hepatic injury.¹

Do not reinitiate therapy in patients with a history of telithromycin- or macrolide-associated hepatitis and/or jaundice.¹

Less severe hepatic dysfunction, including increased liver enzyme concentrations and hepatitis (with or without jaundice), reported; events were reversible.^{1 24}

Prolongation of QT Interval

Potential for prolonged QT interval.¹

Avoid use in patients with congenital or known prolongation of the QT_c interval, those with ongoing proarrhythmic conditions (e.g., uncorrected hypokalemia or hypomagnesemia) or clinically important bradycardia, and those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., dofetilide) antiarrhythmic agents.¹

Ocular Effects

Visual disturbances (blurred vision, diplopia, difficulty focusing) reported, particularly slowed ability to accommodate or release accommodation.¹

Visual disturbances usually occur after first or second dose, but can occur after any dose; problems last several hours and may reoccur with subsequent doses.¹

Usually mild to moderate in severity, but may be severe.¹

Reported most frequently in women and patients <40 years of age.¹

Patients should be cautioned to minimize activities such as driving a motor vehicle, operating heavy machinery, or performing other hazardous activities during treatment and to avoid such activities if they experience visual disturbances.¹

Syncope

Syncope, sometimes associated with vagal syndrome, reported during postmarketing surveillance.¹

Patients should be cautioned to minimize activities such as driving a motor vehicle, operating heavy machinery, or performing other hazardous activities during treatment and to avoid such activities if they experience loss of consciousness.¹

Superinfection/Clostridium difficile-associated Diarrhea

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.^{1 35 36 37 38 39 40 41 42 43 44 45} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported in patients receiving telithromycin.¹ Consider CDAD if diarrhea develops and manage accordingly.^{1 35 36 37 38 39 42 43 44}

Some mild cases of CDAD may respond to discontinuance alone.^{1 35 36 37 38 39 43} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.^{1 35 36 37 38 39 43}

General Precautions

Provide the medication guide for telithromycin to the patient when the drug is dispensed.¹

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of telithromycin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats; may be distributed into human milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Has been investigated in children <13 years of age† for treatment of community-acquired pneumonia.¹⁰

Geriatric Use

Safety and efficacy in those ≥65 years of age similar to that in younger adults, but possibility exists of greater sensitivity to the drug in some geriatric individuals.¹

Hepatic Impairment

Contraindicated in patients with a history of telithromycin-associated hepatitis and/or jaundice.¹ (See Hepatic Effects and see Contraindications under Cautions.)

Reduced dosage required in patients with hepatic impairment and coexisting severe renal impairment.¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Reduced dosage required in patients with severe renal impairment (Cl_cr <30 mL/minute or undergoing dialysis).¹ Further dosage reduction required in patients with severe renal impairment and coexisting hepatic impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea/loose stools, nausea, vomiting, headache, dizziness.^{1 14}

Interactions for Telithromycin

Induces and is metabolized by CYP3A4.^{1 11}

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A4 with possible alteration in metabolism of telithromycin and/or the other drug.¹

Drugs That Prolong QT Interval

Potential pharmacologic interactions (additive effect on QT interval prolongation).¹ Avoid concomitant use with class 1A or class III antiarrhythmic agents.¹ (See Prolongation of QT Interval under Cautions.)

Specific Drugs and Foods

Drug or Food	Interaction	Comments
β-Adrenergic blocking agents (metoprolol, sotalol)	Metoprolol: Increased metoprolol concentrations and AUC; no change in telithromycin exposure with a single metoprolol dose1 Sotalol: Decreased sotalol peak plasma concentrations and AUC1	Metoprolol: Interaction may be clinically important in patients receiving the drug for heart failure; caution advised in heart failure patients1
Antacids (aluminum- and magnesium-containing)	Pharmacokinetic interactions unlikely1
Antiarrhythmic agents	Potential additive effect on QT interval prolongation1	Avoid concomitant use with class 1A (e.g., quinidine, procainamide) or class III (e.g., dofetilide) antiarrhythmics1
Anticoagulants, oral	Potential for enhanced effect of the oral anticoagulant1 11	Monitor PT or INR1 11
Anticonvulsants	Carbamazepine, phenobarbital, or phenytoin: Potential for decreased telithromycin concentrations and/or increased anticonvulsant concentrations1
Antifungals, azoles	Itraconazole or ketoconazole: Increased telithromycin peak plasma concentrations and AUC 1
Antimycobacterials	Rifampin: Decreased telithromycin peak plasma concentrations and AUC1	Rifampin: Avoid concomitant use1
Benzodiazepines (midazolam, triazolam)	Midazolam: Increased midazolam AUC1 Possible pharmacokinetic interactions with other benzodiazepines metabolized by CYP3A and undergoing high first-pass metabolism (e.g., triazolam)1	Midazolam: Monitor patient; consider decreasing midazolam dosage or avoiding concomitant use1 12 Other benzodiazepines (e.g., triazolam): Use concomitantly with caution
Cisapride	Increased cisapride concentrations; increases in QTc interval1	Concomitant use contraindicated1
Digoxin	Increased digoxin concentrations; no evidence of clinically important changes in ECG parameters or digoxin toxicity1	Consider monitoring digoxin concentrations or toxicity1
Ergot alkaloids (dihydroergotamine, ergotamine)	Possible pharmacokinetic interactions; potential for peripheral vasospasm, dysesthesia, acute ergot toxicity1 12	Concomitant use not recommended1
Grapefruit juice	Pharmacokinetic interactions unlikely with 240 mL of juice1
HMG-CoA reductase inhibitors	Possible increased concentrations of atorvastatin, lovastatin, or simvastatin; increased risk of myopathy1 Pharmacokinetic interactions unlikely with fluvastatin or pravastatin1	Avoid concomitant use with atorvastatin, lovastatin, or simvastatin; temporarily suspend therapy with these HMG-CoA reductase inhibitors during telithromycin therapy1
Hormonal contraceptives	Increased levonorgestrel AUC; no change in ethinyl estradiol AUC	No interference with the antiovulatory effect of the oral contraceptive1
Immunosuppressive agents	Potential for increased concentrations of cyclosporine, sirolimus, or tacrolimus1
Paroxetine	Pharmacokinetic interactions unlikely1
Pimozide	Possible increased pimozide concentrations1	Concomitant use contraindicated1
Ranitidine	Pharmacokinetic interactions unlikely1
Repaglinide	Increased plasma concentrations and AUC of repaglinide; increased risk of hypoglycemia26	Consider increased risk of hypoglycemia26
Theophylline	Small increase in theophylline AUC; increased GI effects (nausea, vomiting), especially in women1	Administer telithromycin and theophylline at least 1 hour apart to minimize GI effects1

Telithromycin Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; peak plasma concentrations usually attained within 1 hour.¹

Absolute bioavailability is 57%.¹

Steady-state plasma concentrations attained within 2–3 days with once-daily dosing.¹

Food

Does not affect rate or extent of absorption.^{1 13 14}

Special Populations

Mild to hepatic impairment (Child-Pugh class A, B, or C): Peak plasma concentrations and AUC similar to those in age- and sex-matched healthy individuals.^{1 15}

Severe renal impairment (Cl_cr <30 mL/minute): Increased peak plasma concentrations and AUC.^{1 16}

Geriatric patients ≥65 years of age: AUC 1–2 times higher than in younger adults.¹

Distribution

Extent

Distributed into bronchial mucosa, epithelial lining fluid, alveolar macrophages, sinus tissue, and WBCs.^{1 10}

Plasma Protein Binding

Approximately 60–70% (mainly albumin).¹

Special Populations

Protein binding not altered in geriatric individuals or in those with hepatic impairment.¹

Elimination

Metabolism

70% (33% presystemic and 37% systemic) of a dose metabolized to 1 active metabolite and 3 inactive metabolites.^{1 13 14}

Approximately 50% of metabolism mediated by CYP3A4; remaining 50% does not depend on CYP isoenzymes.^{1 13}

Elimination Route

Eliminated by multiple pathways: 7% eliminated unchanged in feces by biliary and/or intestinal secretion and 13% eliminated unchanged in urine by renal excretion.^{1 10 12 13 14}

Half-life

10 hours.¹

Special Populations

Mild to severe hepatic impairment (Child-Pugh class A, B, or C): Half-life similar to that in age- and sex-matched healthy individuals.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions

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  A ketolide antibiotic.^{1 2 12 13 14} Semisynthetic derivative of erythromycin A, but differs structurally from conventional macrolides.¹⁰

  
  


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  May be bacteriostatic or bactericidal.¹⁴

  
  


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  Like conventional macrolide antibacterials, inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal subunit.^{1 12 13 14 17} Has higher affinity for some ribosomal targets than conventional macrolides.^{1 10 12 13 17}

  
  


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  Gram-positive aerobes: Active in vitro and in clinical infections against Streptococcus pneumoniae (including many multidrug-resistant strains [MDRSP]).^{1 14 18 19 21 22} Also active in vitro against Staphylococcus aureus (oxacillin- and erythromycin-susceptible strains),^{1 14 18} S. pyogenes (group A β-hemolytic streptococci),^{1 14 18 21} S. agalactiae (group B streptococci),¹⁴ and groups C and G streptococci.^{1 14}

  
  


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  Gram-negative aerobes: Active in vitro and in clinical infections against Haemophilus influenzae ^{1 14 18} and Moraxella catarrhalis.^{1 14 18}

  
  


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  Other organisms: Active in vitro and in clinical infections against Chlamydophila pneumoniae(Chlamydia pneumoniae)^{1 14 20} and Mycoplasma pneumoniae.^{1 14} Also active against Legionella pneumophila.¹

  
  


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  Active against some S. pneumoniae resistant to penicillin and/or erythromycin,¹⁸ but S. pneumoniae with reduced susceptibility or resistance to telithromycin have been reported rarely.^{18 46 47}

  
  


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  Some, but not all, erythromycin-resistant S. pyogenes may be susceptible to telithromycin.^{14 18 21} S. aureus resistant to erythromycin usually also resistant to telithromycin.¹⁴

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including telithromycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹

  
  


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  Importance of completing full course of therapy, even if feeling better after a few days.¹ Importance of reporting resistant or worsening symptoms of infections.¹

  
  


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  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with telithromycin or other antibacterials in the future.¹

  
  


• 
  

  Importance of reading the medication guide for telithromycin that is provided to the patient when the drug is dispensed.¹

  
  


• 
  

  Risk of visual disturbances (blurred vision, difficulty focusing, double vision), especially when looking quickly between objects close by and objects far away.¹ Advise patients that avoiding quick changes in viewing between distant and close objects may decrease the effects of these visual difficulties.¹

  
  


• 
  

  Risk of loss of consciousness.¹

  
  


• 
  

  Because of the potential for visual disturbances or loss of consciousness, advise patients to minimize activities such as driving a motor vehicle, operating heavy machines, or performing other hazardous activities.¹ Advise patients experiencing visual difficulties or loss of consciousness to contact their clinician before taking another dose of telithromycin.¹ Advise patients experiencing these symptoms to avoid driving a motor vehicle, operating heavy machines, or engaging in other hazardous activities.¹

  
  


• 
  

  Importance of informing clinicians if they have myasthenia gravis.¹ Telithromycin is contraindicated in patients with myasthenia gravis.¹

  
  


• 
  

  Risk of adverse hepatic effects.¹ Advise patients to immediately discontinue telithromycin and seek medical attention if they experience signs or symptoms of hepatic injury (e.g., nausea, fatigue, anorexia, jaundice, dark urine, light-colored stools, pruritus, tender abdomen).¹ Importance of not reinitiating telithromycin in patients who have experienced hepatitis or jaundice while receiving the drug.¹

  
  


• 
  

  Importance of informing clinician if they have a personal or family history of prolongation of the QT_c interval, proarrhythmic conditions (e.g., uncorrected hypokalemia), or clinically important bradycardia.¹

  
  


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  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹ Especially important to report use of drugs that affect the QT interval (e.g., cisapride, pimozide), antiarrhythmic agents (class IA and III), and/or some HMG-CoA reductase inhibitors (i.e., atorvastatin, lovastatin, simvastatin).¹

  
  


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  Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Telithromycin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	300 mg	Ketek (with povidone)	Sanofi-Aventis
		400 mg	Ketek (with povidone; available in Ketek-Pak 5-day mnemonic blister cards of 10 tablets, regular packaging, and unit-dose blister packages)	Sanofi-Aventis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ketek 400MG Tablets (SANOFI-AVENTIS U.S.): 60/$311.99 or 180/$899.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Sanofi-Aventis. Ketek (telithromycin) tablets prescribing information. Bridgewater, NJ; 2007 Feb.

2. Tellier G, Niederman MS, Nusrat R et al. Clinical and bacteriological efficacy and safety of 5 and 7 day regimens of telithromycin once daily compared with a 10 day regimen of clarithromycin twice daily in patients with mild to moderate community-acquired pneumonia. J Antimicrob Chemother. 2004; 54:515-23. [IDIS 523620] [PubMed 15269191]

3. Dunbar LM, Hassman J, Tellier G. Efficacy and tolerability of once-daily oral telithromycin compared with clarithromycin for the treatment of community-acquired pneumonia in adults. Clin Ther. 2004; 26:48-62. [PubMed 14996517]

4. Pullman J, Champlin J, Vrooman PS Jr. Efficacy and tolerability of once-daily oral therapy with telithromycin compared with trovafloxacin for the treatment of community-acquired pneumonia in adults. Int J Clin Pract. 2003; 57:377-84. [IDIS 499736] [PubMed 12846341]

5. Hagberg L, Torres A, van Rensburg D et al. Efficacy and tolerability of once-daily telithromycin compared with high-dose amoxicillin for treatment of community-acquired pneumonia. Infection. 2002; 30:378-86. [PubMed 12478329]

6. Zervos MJ, Heyder AM, Leroy B. Oral telithromycin 800 mg once daily for 5 days versus cefuroxime axetil 500 mg twice daily for 10 days in adults with acute exacerbations of chronic bronchitis. J Int Med Res. 2003; 31:157-69. [IDIS 517304] [PubMed 12870368]

7. Aubier M, Aldons PM, Leak A et al. Telithromycin is as effective as amoxicillin/clavulanate in acute exacerbations of chronic bronchitis. Respir Med. 2002; 96:862-71. [IDIS 517306] [PubMed 12418583]

8. Luterman M, Tellier G, Lasko B et al. Efficacy and tolerability of telithromycin for 5 or 10 days vs amoxicillin/clavulanic acid for 10 days in acute maxillary sinusitis. Ear Nose Throat J. 2003; 82:576-90. [IDIS 517305] [PubMed 14503094]

9. Buchanan PP, Stephens TA, Leroy B. A comparison of the efficacy of telithromycin versus cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis. Am J Rhinol. 2003; 17:369-77. [IDIS 517307] [PubMed 14750614]

10. Aventis. American Hospital Formulary Service Fact Book: Ketek. 2004 Aug.

11. Kolilekas L, Anagnostopoulos GK, Lampaditis I, Eleftheriadis I. Potential interaction between telithromycin and warfarin. Ann Pharmacother. 2004: 38:1424-7.

12. Anon. Telithromycin (Ketek) for respiratory infections. Med Lett Drugs Ther. 2004; 46:66-8. [PubMed 15314586]

13. Wellington K, Noble S. Telithromycin. Drugs. 2004; 64:1683-94. [PubMed 15257629]

14. Zhanel GG, Walters M, Noreddin A et al. The ketolides: a critical review. Drugs. 2002; 62:1771-804. [PubMed 12149046]

15. Cantalloube C, Bhargava V, Sultan E et al. Pharmacokinetics of the ketolide telithromycin after single and repeated doses in patients with hepatic impairment. Int J Antimicrob Agents. 2003; 22:112-21. [IDIS 517308] [PubMed 12927950]

16. Shi J, Montay G, Chapel S et al. Pharmacokinetics and safety of the ketolide telithromycin in patients with renal impairment. J Clin Pharmacol. 2004; 44:234-4. [IDIS 512832] [PubMed 14973302]

17. Berisio R, Harms J, Schluenzen F et al. Structural insight into the antibiotic action of telithromycin against resistant mutants. J Bacteriol. 2003;185:4276-9.

18. Dohar J, Canton R, Cohen R et al. Activity of telithromycin and comparators against bacterial pathogens isolated from 1,336 patient with clinically diagnosed acute sinusitis. Ann Clin Microbiol Antimicrob. 2004;3:1476-07.

19. Powis J, McGeer A, Green K et al. In vitro antimicrobial susceptibilities of Streptococcus pneumoniae clinical isolates obtained in Canada in 2002. Antimicrob Agents Chemother. 2004;48:3305-11.

20. Miyashita N, Fukano H, Niki Y et al. In vitro activity of telithromycin, a new ketolide, against Chlamydia pneumoniae. J Antimicrob Chemother. 2001;48:403-5.

21. Reinert RR, Lutticken R, Bryskier A et al. Macrolide-resistant Streptococcus pneumoniae and Streptococcus pyogenes in the pediatric population in Germany during 2000–2001. Antimicrob Agents Chemother. 2003;47:489-93.

22. Brown SD, Tybak MJ. Antimicrobial susceptibility of Streptococcus pneumoniae, Streptococcus pyogenes and Haemophilus influenzae collected from patients across the USA, in 2001-2002, as part of the PROTEKT US study. J Antimicrob Chemother. 2004;54 (Suppl 1):17-115.

23. Adventis Pharmaceuticals, Bridgewater, N: Personal communication.

24. Clay KD, Hanson JS, Pope SD et al. Brief communication: severe hepatotoxicity of telithromycin: three case reports and literature review. Ann Intern Med. 2006; 144:415-20. [PubMed 16481451]

25. Nenciu LM, Laberge P, Thirion DJ. Telithromycin-induced digoxin toxicity and electrocardiographic changes. Pharmacotherapy. 2006; 26:872-6. [PubMed 16716140]

26. Kajosaari LI, Niemi M, Backman JT et al. Telithromycin, but not montelukast, increases the plasma concentrations and effects of the cytochrome P450 3A4 and 2C8 substrate repaglinide. Clin Pharmacol Ther. 2006; 79:231-42. [PubMed 16513447]

27. Young D. Panel urges black-box warning for Ketek. From the American Society of Health-System Pharmacists website (.).

28. Department of Health and Human Services, Food and Drug Administration. Joint meeting of the anti-infective drugs advisory committee and the drug safety and risk management advisory committee: notice of meeting. Fed Regist. 2006; 71:66545.

29. Perrot X, Bernard N, Vial C et al. Myasthenia gravis exacerbation or unmasking associated with telithromycin treatment. Neurology. 2006; 67:2256-8. [PubMed 17065592]

30. Nieman RB, Sharma K, Edelberg H, Caffe SE. Telithromycin and myasthenia gravis. Clin Infect Dis. 2003; 37:1579. Letter. [PubMed 14614683]

31. Jennett AM, Bali D, Jasti P et al. Telithromycin and myasthenia crisis. Clin Infect Dis. 2006; 43:1621-2. Letter. [PubMed 17109301]

32. Aventis. Ketek (telithromycin) tablets prescribing information. Kansas City, MO; 2004.

33. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on management of community-acquired pneumonia in adults. Clin Infect Dis. 2007; 44 (suppl 2):S27-72. [PubMed 17278083]

34. Food and Drug Administration. Telithromycin (marketed as Ketek) information. 2007 Feb 12. from FDA website (.

35. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]

36. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

37. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

38. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

39. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]

40. McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N Engl J Med. 2005; 353:2433-41. [PubMed 16322603]

41. Loo VG, Poirier L, Miller MA et al. A predominantly clonal multi-institutional outbreak of Clostricium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005; 353:2442-9. [PubMed 16322602]

42. McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006; 12:409-15. [PubMed 16704777]

43. Bartlett JG, Peri TM. The new Clostridium difficile–what does it mean? N Engl J Med. 2005; 353:2503-5.

44. Centers for Disease Control and Prevention. Severe Clostridium difficile-associated disease in populations previously at low risk–four states, 2005. MMWR Morb Mortal Wkly Rep. 2005; 54:1201-5. [PubMed 16319813]

45. Kazakova SV, Ware K, Baughman B et al. A hospital outbreak of diarrhea due to an emerging epidemic strains of Clostridium difficile. Arch Intern Med. 2006; 166:2518-24. [PubMed 17159019]

46. Al-Lahham A, Appelbaum PC, van der Linden M et al. Telithromycin-nonsusceptible clinical isolates of Streptococcus pneumoniae from Europe. Antimicrob Agents Chemother. 2006; 50:3897-900.

47. Wolter N, Smith AM, Low DE et al. High-level telithromycin resistance in a clinical isolate of Streptococcus pneumoniae. Antimicrob Agents Chemother. 2007; 51:1092-5. [PubMed 17210764]

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