Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
telithromycin (UNII: KI8H7H19WL) (telithromycin - UNII:KI8H7H19WL)
Physicians Total Care, Inc.
telithromycin
telithromycin 400 mg
ORAL
PRESCRIPTION DRUG
KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression. KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic. KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic. Concomitant administration of KETEK with cisapride or pimozide is contraindicated. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions and PRECAUTIONS .) Concomitant administration of KETEK and colchicine is contraindicated in patients with renal or hepatic impairment. (See WARNINGS, Drug Interactions and PRECAUTIONS, Drug interactions .)
KETEK® 400 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "H3647" on one side and "400" on the other side. These are packaged in bottles or blister cards (Ketek Pak™ and unit dose) as follows: Ketek Pak™, 10-tablet cards (2 tablets per blister cavity) (NDC 54868-5171-0) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
New Drug Application
Physicians Total Care, Inc. ---------- MEDICATION GUIDE KETEK® (KEE tek) (telithromycin) Tablets Read the Medication Guide that comes with KETEK before you start taking it and each time you get a new prescription. There may be new information. Talk to your doctor if you have any questions about KETEK. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about KETEK? Do not take KETEK if you have myasthenia gravis (a rare disease which causes muscle weakness). Worsening of myasthenia gravis symptoms including life-threatening breathing problems have happened in people with myasthenia gravis after taking KETEK, in some cases leading to death. KETEK can cause other serious side effects, including: 1. Severe liver damage (hepatotoxicity). Severe liver damage, in some cases leading to a liver transplant or death has happened in people treated with KETEK. Severe liver damage has happened during treatment, even after a few doses, or right after treatment with KETEK has ended. Stop taking KETEK and call your doctor right away if you have signs of liver problems. Do not take another dose of KETEK unless your doctor tells you to. Signs of liver problems include: • increased tiredness • loss of appetite • nausea • yellowing of your skin or whites of your eyes • dark colored urine (tea colored) • light colored stools • right upper belly pain • itchy skin Do not take KETEK if you have ever had liver problems while taking KETEK or macrolide antibiotics. Macrolide antibiotics include: • erythromycin • azithromycin (Zithromax®, Zmax®) • clarithromycin (Biaxin®) • dirithromycin (Dynabac®) 2. Vision problems. KETEK may cause you to have blurred vision, trouble focusing your eyes, and double vision. You may especially notice vision problems if you look quickly between objects close to you and objects far away from you. 3. Fainting. KETEK may cause you to faint, especially if you also have read_full_document
KETEK - TELITHROMYCIN TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- KETEK (TELITHROMYCIN) TABLETS KETEK 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 and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION 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-3-C-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 C H N O 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 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. CLINICAL PHARMACOLOGY ® ® 43 65 5 10 PHARMACOKINETICS Absorption Following oral administration, telithromycin reached maximal concentration at about 1 hour (0.5 – 4 hours). It has an absolute bioavailability of 57% in both young and elderly subjects. The rate a read_full_document