Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Fresenius Kabi USA, LLC
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE 150 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the
Clindamycin Injection, USP, in the Pharmacy Bulk Package, supplied as clindamycin phosphate equivalent to clindamycin 150 mg/mL, is available as: Packaged individually. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
CLINDAMYCIN - CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- CLINDAMYCIN INJECTION USP Rx only PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION FOR INTRAVENOUS USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING _Clostridium difficile-_associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Injection, USP and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of _C. difficile_. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. _C. difficile _produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of _C._ _difficile _cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against _C. difficile _may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of _C. difficile_, and surgical evaluation should be instituted as clinically indicated. DESCRIPTION: Clindamycin Injection, USP for intravenous use contains clin Aqra d-dokument sħiħ