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Ketek (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 Ketek. (See CONTRAINDICATIONS.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK (telithromycin) and other antibacterial drugs, KETEK (telithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
KETEK® tablets contain telithromycin, a semisynthetic antibacterial in the ketolide class for oral administration. Chemically, telithromycin is designated as Erythromycin, 3-de[(2,6-dideoxy-3C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-11,12-dideoxy-6-O-methyl-3-oxo-12,11[oxycarbonyl[[4-[4-(3-pyridinyl)-1H-imidazol-1-yl]butyl]imino]]-.
Telithromycin, a ketolide, differs chemically from the macrolide group of antibacterials by the lack of α-L-cladinose at position 3 of the erythronolide A ring, resulting in a 3-keto function. It is further characterized by a C11-12 carbamate substituted by an imidazolyl and pyridyl ring through a butyl chain. Its empirical formula is C43H65N5O10 and its molecular weight is 812.03. Telithromycin is a white to off-white crystalline powder. The following represents the chemical structure of telithromycin.
KETEK (telithromycin) tablets are available as light-orange, oval, film-coated tablets, each containing 400 mg or 300 mg of telithromycin, and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, red ferric oxide, talc, titanium dioxide, and yellow ferric oxide.
What are the possible side effects of telithromycin (Ketek, Ketek Pak)?
Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using telithromycin and call your doctor at once if you have a serious side...
What are the precautions when taking telithromycin (Ketek)?
Before taking telithromycin, tell your doctor or pharmacist if you are allergic to it; or to macrolide antibiotics (e.g., azithromycin, clarithromycin, dirithromycin, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: myasthenia gravis, previous liver problems (e.g., yellowing eyes/skin, dark urine) while taking telithromycin or a macrolide antibiotic, previous allergic reaction to telithromycin or a macrolide antibiotic.
Before using this medication, tell your doctor or pharmacist...
Last reviewed on RxList: 1/27/2011
This monograph has been modified to include the generic and brand name in many instances.
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