Dosing and uses of Ketek (telithromycin)
Adult dosage forms and strengths
tablet
- 400mg
Pneumonia
Indicated for treatment of community-acquired pneumonia due to Streptococcus pneumoniae, (including multi-drug resistant isolates), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae
800 mg PO qDay for 7-10 days
Dosage modifications
Renal impairment (CrCl <30 mL/min): 600 mg PO qDay
Renal impairment (CrCl <30 mL/min) and hepatic impairment: 400 mg PO qDay
Severe renal impairment (dialysis dependent): 600 mg PO administered 2 hr postdialysis
Administration
May take with or without food
Pediatric dosage forms and strengths
Safety and efficacy not established
Ketek (telithromycin) adverse (side) 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
Warnings
Black box warnings
Fatal and life-threatening respiratory failure have been reported in patients with myasthenia gravis who were treated with this drug
Contraindications
Hypersensitivity to telithromycin or any macrolide antibiotic
Concomitant administration with cisapride, pimozide, astemizole, terfenadine, ergot alkaloids
Coadministration of colchicine with telithromycin in patients with renal/hepatic impairment
Myasthenia Gravis
Cautions
May prolong QT intervaL
Avoid coadministration with colchicine; if telithromycin is prescribed in patients with normal renal/hepatic function, decrease the dose of colchicine
Cases of ventricular arrhythmias, including ventricular tachycardia and torsades de pointes, reported
Risk of C. difficile pseudomembranous colitis
Risk of serious hepatotoxicity
Risk of visual disturbances & LOC
Pregnancy and lactation
Pregnancy category: B
Lactation: may be excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ketek (telithromycin)
Mechanism of action
Ketolide antibiotic (related to macrolides); suppresses protein synthesis by binding to bacterial 50S ribosomal subunit, and inhibits assembly of new bacterial ribosomes.
Absorption
Bioavailability: 57%
Peak Plasma Time: 1 hr
Distribution
Protein Bound: 60-70%
Vd: 2.9 L/kg
Metabolism
Hepatic P450 enzyme CYP3A4
Enzymes inhibited: CYP3A4; CYP2D6 (mild)
Elimination
Half-life: 10 hr
Excretion: urine, bile
