Telithromycin

Name: Telithromycin

Adverse Effects

>10%

Diarrhea

1-10%

Dizziness

Nausea

Vomiting

Rashes

Stevens-Johnson syndrome

Urticaria

<1%

Pseudomembranous colitis

QT prolongation

Exacerbation of myasthenia gravis

Anaphylaxis

Postmarketing Reports

Ventricular arrhythmias with fatal outcome, ischemic cardiac events in the context of hypersensitivity reactions

Pseudomembranous colitis

Chromaturia

Convulsions

Dyspnea

What Is Telithromycin?

Telithromycin is an antibiotic that fights bacteria.

Telithromycin is used to treat mild to moderate pneumonia caused by certain types of bacteria.

Telithromycin may also be used for purposes not listed in this medication guide.

Do not take this medicine if you have ever had an allergic reaction or liver problems caused by telithromycin or similar antibiotics. You should not take telithromycin if you also take cisapride or pimozide, or if you have kidney or liver disease AND you are also taking colchicine.

Do not take telithromycin if you have myasthenia gravis. Some people with myasthenia gravis have developed serious or fatal lung problems while taking telithromycin.

You should not use telithromycin if you are allergic to it, or if:

  • you have myasthenia gravis;
  • you have ever had an allergic reaction or liver problems while taking telithromycin or similar antibiotics, such as azithromycin (Zithromax), erythromycin, clarithromycin (Biaxin), troleandomycin (TAO), or dirithromycin (Dynabac);
  • you also take cisapride or pimozide (Orap); or
  • you have kidney or liver disease AND you are taking colchicine (Colcrys).

Some people with myasthenia gravis have developed serious or fatal lung problems while taking telithromycin.

To make sure telithromycin is safe for you, tell your doctor if you have:

  • liver disease;
  • kidney disease;
  • low levels of potassium or magnesium in your blood;
  • a heart rhythm disorder (especially if you take certain medications to treat it);
  • very slow heartbeats; or
  • a personal or family history of long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Telithromycin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Telithromycin is not approved for use by anyone younger than 18 years old.

Telithromycin Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of telithromycin there are no specific foods that you must exclude from your diet when receiving telithromycin.

Telithromycin and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if telithromycin will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Telithromycin and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if telithromycin passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take telithromycin.

Telithromycin Usage

  • Take telithromycin exactly as your doctor tells you.
  • Skipping doses or not taking all of an antibiotic may:
    • make the treatment not work as well
    • increase the chance that the bacteria will develop resistance to the antibiotic
  • If you have kidney disease, your doctor may prescribe a lower dose for you.
  • Take telithromycin with or without food.
  • Swallow telithromycin tablets whole.
  • If you take too much telithromycin, call your doctor, or go to the nearest hospital emergency room right away.

What is telithromycin?

Telithromycin is an antibiotic that fights bacteria.

Telithromycin is used to treat mild to moderate pneumonia caused by certain types of bacteria.

Telithromycin may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

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

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

Commonly used brand name(s)

In the U.S.

  • Ketek
  • Ketek Pak

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antibiotic

Chemical Class: Ketolide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Ketek: 300 mg [DSC], 400 mg [DSC]

Dosing Renal Impairment

CrCl ≥ 30 mL/minute: No dosage adjustment necessary

CrCl <30 mL/minute: 600 mg once daily

CrCl <30 mL/minute and concomitant hepatic impairment: 400 mg once daily

Hemodialysis: 600 mg once daily; administer after dialysis on dialysis days

ALERT U.S. Boxed Warning

Myasthenia gravis:

Telithromycin is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of telithromycin.

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