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Pharmacologic class: Ketolide antibiotic
Therapeutic class: Anti-infective
Pregnancy risk category C
FDA Box Warning
Drug is contraindicated in myasthenia gravis because life-threatening or fatal respiratory failure has occurred in these patients.
Blocks protein synthesis by binding to domains II and V of 23S rRNA of 50S ribosomal subunit. Binding at domain II enables drug to retain activity against gram-positive cocci in resistance mediated by methylases that alter domain-V binding site.
Tablets (film-coated): 300 mg, 400 mg
Indications and dosages
➣ Mild to moderate community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant isolates), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae
Adults age 18 and older: 800 mg P.O. daily for 7 to 10 days
• Severe renal impairment, with or without coexisting hepatic impairment
• Hypersensitivity to drug, its components, or macrolide antibiotics
• History of hepatitis or jaundice with previous use of telithromycin or macrolide antibiotics
• Concurrent use of cisapride or pimozide
• Myasthenia gravis
Use cautiously in:
• severe renal impairment, hepatic dysfunction, congenital prolongation of QT interval, ongoing proarrhythmic conditions (such as uncorrected hypokalemia or hypomagnesemia), clinically significant bradycardia (use should be avoided)
• concurrent use of some HMG-CoA reductase inhibitors (atorvastatin, lovastatin, simvastatin), rifampin, and Class IA or Class III antiarrhythmics (use should be avoided)
• concurrent use of midazolam and other benzodiazepines metabolized by CYP3A4 that undergo high first-pass effect (such as triazolam)
• concurrent use of ergot alkaloid derivatives, metoprolol, or rifampin (use not recommended)
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).
• Administer tablets whole with or without food.
• Give at least 1 hour before or after theophylline (if prescribed).
Don't give currently with cisapride or pimozide.
CNS: headache, dizziness, fatigue, loss of consciousness
CV: prolonged QT interval with increased risk of ventricular arrhythmias and torsades de pointes
EENT: visual disturbances, poor visual accommodation
GI: nausea, vomiting, diarrhea, loose stools, light-colored stools, dysgeusia, anorexia, pseudomembranous colitis (possibly caused by Clostridium difficile)
GU: dark urine
Hepatic: abnormal hepatic function, fulminant hepatitis, hepatic necrosis, hepatic failure
Other: superinfection, hypersensitivity reactions including angioedema and anaphylaxis (rare), acute myasthenia gravis exacerbation
Drug-drug. Atorvastatin, lovastatin, simvastatin: increased blood levels of these drugs, increased myopathy risk
Benzodiazepines metabolized by CYP3A4 (such as midazolam, triazolam): increased blood levels of these drugs
Cisapride, pimozide: increased blood levels of these drugs, increasing risk of significantly prolonged QT interval
Class IA antiarrhythmics (such as procainamide, quinidine), Class III antiarrhythmics (such as dofetilide): interference with antiarrhythmic efficacy
Colchicine: increased serum colchicine blood level and toxicity risk
Cyclosporine, sirolimus, tacrolimus: increased blood levels of these drugs, with increased toxicity risk CYP3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin): subtherapeutic telithromycin blood level CYP3A4 inhibitors (such as itraconazole, ketoconazole): increased telithromycin blood level
Digoxin: increased peak and trough digoxin levels
Ergot alkaloid derivatives (such as dihydroergotamine, ergotamine): acute ergot toxicity
Hexobarbital: increased hexobarbital blood level and toxicity risk
Metoprolol: increased metoprolol effect
Oral anticoagulants: possible potentiation of these drugs
Sotalol: decreased sotalol absorption
Theophylline: increased theophylline blood level, with exacerbated adverse GI reactions
Verapamil: increased verapamil blood level, causing increased risk of cardiotoxicity
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels
• Monitor liver function tests frequently.
Discontinue drug permanently if patient develops clinical hepatitis or transaminase elevations and other systemic symptoms.
• Monitor patient closely for adverse GI reactions, especially diarrhea.
• In patients receiving drug concurrently with anticoagulants, stay alert for potentiation of anticoagulant effects.
• In patients receiving drug concurrently with midazolam, stay alert for need to adjust midazolam dosage.
• In patients receiving drug concurrently with digoxin, monitor peak and trough digoxin levels periodically, and stay alert for adverse reactions to digoxin.
• Ensure that patient has received and read medication guide that comes with drug.
• Instruct patient to take tablet whole with or without food.
• Advise patient to take drug at least 1 hour before or after theophylline (if prescribed).
• Stress importance of completing full course of therapy, even if patient feels better.
Urge patient to immediately stop taking drug and report signs and symptoms of liver damage, such as nausea, fatigue, appetite loss, yellowing of skin or eyes, dark urine, light-colored stools, itching, and tender abdomen.
Instruct patient to immediately report fainting episodes or signs of heartbeat irregularities.
Urge patient to immediately report watery or loose stools even as late as several months after taking the last dose.
Advise patient to immediately report itching, throat swelling, and other signs or symptoms of allergic reaction.
• Inform patient that drug may cause visual disturbances.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects vision and alertness.
• Advise patient to consult prescriber before taking other prescription or over-the-counter drugs or dietary supplements.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
ClassificationTherapeutic: anti infectives
Time/action profile (blood levels)
|PO||rapid||1 hr||24 hr|
Adverse Reactions/Side Effects
Central nervous system
- loss of consciousness
Ear, Eye, Nose, Throat
- visual disturbances
- QTc interval prolongation
- pseUdomembranous colitis (life-threatening)
- diarrhea (most frequent)
- HEPATotoxicity (life-threatening)
- exacerbation of myasthenia gravis
Drug-Drug interactionBlood levels are ↑ by ketoconazole and itraconazole.↑ levels and risk of myopathy from simvastatin, lovastatin, and atorvastatin ; avoid concurrent use.↑ levels and risk of toxicity with colchicine ; avoid concurrent use in patients with renal or hepatic impairment; ↓ dose of colchicine if patients have normal renal and hepatic function.↑ levels and risk of excessive sedation with midazolam ; careful titration is required. Similar effects may occur with triazolam.↑ levels of metoprolol ; use caution in patients with HF.May also ↑ levels, effects and risk of toxicity from ergot derivatives (ergotamine, dihydroergotamine ); concurrent use not recommended; similar effects may occur with carbamazepine, cyclosporine, tacrolimus, sirolimus, hexobarbital, or phenytoin.Rifampin ↓ levels and effectiveness; avoid concurrent use. Similar effects may occur with phenytoin, carbamazepine, or phenobarbital.
- Assess for infection (vital signs; sputum, WBC) at beginning of and during therapy.
- Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
- Determine any family history of QTc prolongation or proarrythmic conditions (hypokalemia, bradycardia).
- Monitor for signs or symptoms of hepatitis (fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly). If these occur, discontinue telithromycin immediately and monitor liver function; do not re-administer telithromycin.
- Lab Test Considerations: May cause ↑ platelet count.
- Monitor liver function periodically during therapy and if signs of hepatitis occur.
Potential Nursing DiagnosesRisk for infection (Indications)
Noncompliance (Patient/Family Teaching)
- Oral: Administer with or without food. Swallow tablets whole; do not crush, break, or chew.
- Instruct patient to take medication as directed and to finish medication completely, even if feeling better. Take missed doses as soon as remembered, but do not take more than one dose in a 24–hr period. Advise patient to read Patient Information Sheet prior to starting therapy.
- May cause visual disturbances (blurred vision, difficulty focusing, diplopia). Caution patient to avoid driving or other activities requiring visual acuity until response to medication is known. Advise patient to notify health care professional if visual disturbances interfere with daily activities.
- Instruct patient to notify health care professional if fainting occurs.
- Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools).
- Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
- Advise patient to discontinue telithromycin and notify health care professional immediately if signs of liver injury (nausea, fatigue, anorexia, jaundice, dark urine, light-colored stools, pruritus, or tender abdomen) occur.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
- Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.