Telithromycin

KETEK

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Pronunciation: tel-ith-roe-MYE-sin (KEE-tek)

Telithromycin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Telithromycin ballicule

What it isKetolide inhibiting the 50S subunit; withdrawn.

Why this oneIt retained activity against macrolide-resistant pneumococcus.

What limits itFatal hepatotoxicity and visual disturbance, and it is contraindicated in myasthenia gravis. Withdrawn.

Telithromycin molecular structure (skeletal formula) — Molecular structure: Telithromycin

Telithromycin prescription history

Animated chart of estimated U.S. prescriptions per year, Antibacterials (systemic) (1938–2026). Telithromycin enters in 2004 (estimated).

FDA-approved for

community-acquired pneumonia (2004)

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Sedation liability1 / 4

QT / Torsades2 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilitySevere hepatotoxicity, myasthenic respiratory failure and QT risk

FDA label

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BOXED WARNING Contraindicated in myasthenia gravis — fatal/life-threatening respiratory failure reported.

FDA dosing	Population	Start	Target	Max
Community-acquired pneumonia (mild-moderate)	Adults	800 mg QD	800 mg QD × 7–10 days	800 mg QD

Renal CrCl <30 (incl. dialysis): 600 mg QD; CrCl <30 with coexisting hepatic impairment: 400 mg QD; give after dialysis on dialysis days

Hepatic No adjustment for hepatic impairment alone

Instructions

Take orally once every 24 hours, with or without food
In hemodialysis patients, give after the dialysis session on dialysis days

Available strengths

tab 400 mg

Contraindications

Myasthenia gravis
Prior hepatitis and/or jaundice with Ketek or any macrolide
Concomitant cisapride or pimozide
Concomitant colchicine in renal or hepatic impairment

Cautions

Exacerbation of myasthenia gravis (may be fatal, rapid onset)
Hepatotoxicity — hepatitis and hepatic failure reported
QT prolongation risk
Visual disturbances and loss of consciousness reported

Adverse reactions

Diarrhea, nausea, headache, dizziness, vomiting, loose stools, dysgeusia

Pregnancy Pregnancy Category C — not teratogenic in animals; use only if benefit justifies risk

Lactation Undefined

Cost

Telithromycin (KETEK)

Strength		#/mo	generic $/mo	CostPlus
400 mg	tab	30 qd		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Telithromycin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

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Self-check

Against which resistant respiratory pathogen did telithromycin retain activity?
Macrolide-resistant pneumococcus.
Which neuromuscular disease contraindicates telithromycin?
Myasthenia gravis.