País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)
Pharmacia & Upjohn Company LLC
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 150 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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. CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designa
Each mL of CLEOCIN PHOSPHATE Sterile Solution contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate; 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. CLEOCIN PHOSPHATE is available in the following packages: 25-2 mL vials NDC 0009-0302-25 25-4 mL vials NDC 0009-0602-25 25-6 mL vials NDC 0009-0901-25 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. CLEOCIN PHOSPHATE IV Solution in GALAXY plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. The single dose GALAXY plastic containers are available as follows: 300 mg/50 mL 24 Single Dose Bags NDC 0009-3470-02 600 mg/50 mL 24 Single Dose Bags NDC 0009-6780-02 900 mg/50 mL 24 Single Dose Bags NDC 0009-9890-02 Exposure of pharmaceutical products to heat should be minimized. It is recommended that GALAXY plastic containers be stored at room temperature (25°C). Avoid temperatures above 30°C.
New Drug Application
CLEOCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION PHARMACIA & UPJOHN COMPANY LLC ---------- CLEOCIN PHOSPHATE (CLINDAMYCIN INJECTION, USP) AND (CLINDAMYCIN INJECTION IN 5% DEXTROSE) To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. STERILE SOLUTION IS FOR INTRAMUSCULAR AND INTRAVENOUS USE WARNING _Clostridioides difficile_-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE Steri Leer el documento completo