telithromycin (Discontinued)

Brand and Other Names:Ketek
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Discontinued in the U.S. in 2016

Pneumonia

Discontinued in the U.S. in 2016

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

Safety and efficacy not established

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Interactions

Interaction Checker

and telithromycin

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

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            Pregnancy & 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.

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            Pharmacology

            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

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.