appears [1000:28 days of treatment with another oxazolidinone anti-infective (not tedizolid). 1 In phase 3 studies of tedizolid in patients with acute bacterial skin and skin structure infections, peripheral neuropathy and optic nerve disorders reported in similar frequencies in those treated with tedizolid or linezolid. 1 Data not available for patients exposed to >6 days of tedizolid. 1 Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD) Possible emergence and overgrowth of nonsusceptible bacteria or fungi. 1 Monitor carefully; institute appropriate therapy if superinfection occurs. 1 Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile . 1 12 14 15 C. difficile infection (CDI) and C. difficile -associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including tedizolid, and may range in severity from mild diarrhea to fatal colitis. 1 12 14 15 C. difficile produces toxins A and B which contribute to development of CDAD; 1 12 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required. 1 Consider CDAD if diarrhea develops during or after therapy and manage accordingly. 1 12 14 15 Obtain careful medical history since CDAD may occur as late as 2 months after anti-infective therapy is discontinued. 1 If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. 1 12 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated. 1 12 14 15 Selection and Use of Anti-infectives To reduce development of drug-resistant bacteria and maintain effectiveness of tedizolid and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria. 1 When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. 1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy. 1 Specific Populations Pregnancy Category C. 1 Use during pregnancy only if potential benefits justify potential risks to fetus. 1 No adequate and well-controlled studies in pregnant women; 1 animal studies (mice, rats, rabbits) revealed reduced fetal weight, costal cartilage anomalies, increased skeletal variations, and/or reduced maternal weight at dosages at least 4 times estimated human exposure. 1 Lactation Distributed into milk in rats; 1 not known whether distributed into human milk. 1 Use with caution in nursing women. 1 Pediatric Use Safety and efficacy not established in pediatric patients] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Merck & Co., Inc. Drug Class Oxazolidinone antibiotics Related Drugs Skin and Structure Infection ciprofloxacin , azithromycin , Augmentin , Zithromax , cefdinir , ceftriaxone , cefuroxime , mupirocin topical , Rocephin , Bactroban , Ceftin , More... Bacterial Infection ciprofloxacin , amoxicillin , azithromycin , doxycycline , cephalexin , metronidazole , Augmentin , Zithromax , Levaquin , Keflex , levofloxacin , More... Sivextro Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! thinking of
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