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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.)


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2004,32 approval for treatment of acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis was withdrawn in 2007 because of safety concerns.34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


Oral Administration

Administer orally once daily without regard to meals.1



Respiratory Tract Infections
Community-acquired Pneumonia

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 (Clcr <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 (Clcr <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 (Clcr <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


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

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

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

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



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 QTc 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, 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


Category C.1


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 (Clcr <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

Inhibits 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



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


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


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


Increased cisapride concentrations; increases in QTc interval1

Concomitant use contraindicated1


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


Pharmacokinetic interactions unlikely1


Possible increased pimozide concentrations1

Concomitant use contraindicated1


Pharmacokinetic interactions unlikely1


Increased plasma concentrations and AUC of repaglinide; increased risk of hypoglycemia26

Consider increased risk of hypoglycemia26


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



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


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 (Clcr <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



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



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


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





25°C (may be exposed to 15–30°C).1


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

  • May be bacteriostatic or bactericidal.14

  • 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

  • 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

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

  • 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

  • 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

  • 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

  • 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

  • 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 QTc interval, proarrhythmic conditions (e.g., uncorrected hypokalemia), or clinically important bradycardia.1

  • 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

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

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


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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.



Dosage Forms


Brand Names



Tablets, film-coated

300 mg

Ketek (with povidone)


400 mg

Ketek (with povidone; available in Ketek-Pak 5-day mnemonic blister cards of 10 tablets, regular packaging, and unit-dose blister packages)


AHFS DI Essentials. © Copyright 2018, Selected Revisions October 3, 2014. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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


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