Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4246
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Cefobid (Powder, For Solution)
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Sterile cefoperazone sodium can be administered by IM or IV injection (following dilution). However, the intent of this pharmacy bulk package is for the preparation of solutions for IV infusion only. The usual adult daily dose of CEFOBID is 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6���12 grams divided into 2, 3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days. If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoperazone has no activity against this organism. Solutions of CEFOBID and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with CEFOBID and an aminoglycoside is contemplated this can be accomplished by sequential intermittent intravenous infusion provided that separate secondary intravenous tubing is used, and that the primary intravenous tubing is adequately irrigated with an approved diluent between doses. It is also suggested that CEFOBID be administered prior to the aminoglycoside. In vitro testing of the effectiveness of drug combination(s) is recommended. In a pharmacokinetic study, a total daily dose of 16 grams was administered to severely immunocompromised patients by constant infusion without complications. Steady-state serum concentrations were approximately 150 mcg/mL in these patients.
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CEFOBID' (cefoperazone), formerly known as cefoperazone sodium, is a sterile, semisynthetic, broad-spectrum, parenteral cephalosporin antibiotic for intravenous or intramuscular administration. It is the sodium salt of 7-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-(p-hydroxyphenyl)acetamido-3-[[(1-methyl-H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Its chemical formula is CHNNaOSwith a molecular weight of 667.65. The structural formula is given below: CEFOBID contains 34 mg sodium (1.5 mEq) per gram. CEFOBID is a white powder which is freely soluble in water. The pH of a 25% (w/v) freshly reconstituted solution varies between 4.5���6.5 and the solution ranges from colorless to straw yellow depending on the concentration. CEFOBID in crystalline form is supplied in vials equivalent to 1 g or 2 g of cefoperazone. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. This Pharmacy Bulk Package is for use in a pharmacy admixture service; it provides many single doses of cefoperazone for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion.
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High serum and bile levels of CEFOBID are attained after a single dose of the drug. Table 1 demonstrates the serum concentrations of CEFOBID in normal volunteers following either a single 15-minute constant rate intravenous infusion of 1, 2, 3 or 4 grams of the drug, or a single intramuscular injection of 1 or 2 grams of the drug. The mean serum half-life of CEFOBID is approximately 2.0 hours, independent of the route of administration. In vitro studies with human serum indicate that the degree of CEFOBID reversible protein binding varies with the serum concentration from 93% at 25 mcg/mL of CEFOBID to 90% at 250 mcg/mL and 82% at 500 mcg/mL. CEFOBID achieves therapeutic concentrations in the following body tissues and fluids: CEFOBID is excreted mainly in the bile. Maximum bile concentrations are generally obtained between one and three hours following drug administration and exceed concurrent serum concentrations by up to 100 times. Reported biliary concentrations of CEFOBID range from 66 mcg/mL at 30 minutes to as high as 6000 mcg/mL at 3 hours after an intravenous bolus injection of 2 grams. Following a single intramuscular or intravenous dose, the urinary recovery of CEFOBID over a 12-hour period averages 20���30%. No significant quantity of metabolites has been found in the urine. Urinary concentrations greater than 2200 mcg/mL have been obtained following a 15-minute infusion of a 2 g dose. After an IM injection of 2 g, peak urine concentrations of almost 1000 mcg/mL have been obtained, and therapeutic levels are maintained for 12 hours. Repeated administration of CEFOBID at 12-hour intervals does not result in accumulation of the drug in normal subjects. Peak serum concentrations, areas under the curve (AUC's), and serum half-lives in patients with severe renal insufficiency are not significantly different from those in normal volunteers. In patients with hepatic dysfunction, the serum half-life is prolonged and urinary excretion is increased. In patients with combined renal and hepatic insufficiencies, CEFOBID may accumulate in the serum. CEFOBID has been used in pediatrics, but the safety and effectiveness in children have not been established. The half-life of CEFOBID in serum is 6���10 hours in low birth-weight neonates.<br/>Microbiology: CEFOBID is active in vitro against a wide range of aerobic and anaerobic, gram-positive and gram-negative pathogens. The bactericidal action of CEFOBID results from the inhibition of bacterial cell wall synthesis. CEFOBID has a high degree of stability in the presence of beta-lactamases produced by most gram-negative pathogens. CEFOBID is usually active against organisms which are resistant to other beta-lactam antibiotics because of beta lactamase production. CEFOBID is usually active against the following organisms in vitro and in clinical infections:<br/>Gram-Positive Aerobes:<br/>Gram-Negative Aerobes:<br/>Anaerobic Organisms: CEFOBID is also active in vitro against a wide variety of other pathogens although the clinical significance is unknown. These organisms include: Salmonella and Shigella species,Serratia liquefaciens, N. meningitidis, Bordetella pertussis, Yersinia enterocolitica, Clostridium difficile, Fusobacterium species, Eubacterium species and beta-lactamase producing strains of H.influenzae and N. gonorrhoeae.
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CEFOBID is contraindicated in patients with known allergy to the cephalosporin-class of antibiotics.
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CEFOBID sterile powder is available in Pharmacy Bulk Package containing cefoperazone sodium equivalent to 10 g cefoperazone��1 (NDC 0049-1219-28).<br/>OTHER SIZE PACKAGES AVAILABLE: CEFOBID sterile powder is available in vials containing cefoperazone sodium equivalent to 1 g cefoperazone��10 (NDC 0049-1201-83) and 2 g cefoperazone��10 (NDC 0049-1202-83) for intramuscular and intravenous administration.
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cefoperazone
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Cefobid (Powder, For Solution)
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In clinical studies the following adverse effects were observed and were considered to be related to CEFOBID therapy or of uncertain etiology:<br/>Hypersensitivity: As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.<br/>Hematology: As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10.<br/>Hepatic: Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during CEFOBID therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID therapy was discontinued, the patient's enzymes returned to pre-treatment levels andthe symptomatology resolved. As with other antibiotics that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5���10% of the patients receiving CEFOBID therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established.<br/>Gastrointestinal: Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely. Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibiotic therapy .<br/>Renal Function Tests: Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.<br/>Local Reactions: CEFOBID is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOBID is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.
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CEFOBID is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections caused by S. pneumoniae, H. influenzae, S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes(Group A beta-hemolytic streptococci), P. aeruginosa, Klebsiella pneumoniae, E. coli, Proteus mirabilis, and Enterobacter species. Peritonitis and Other Intra-abdominal Infections caused by E. coli, P. aeruginosaand anaerobic gram-negative bacilli (including Bacteroides fragilis). Bacterial Septicemia caused by S. pneumoniae, S. agalactiae,S. aureus, Pseudomonas aeruginosa,E. coli, Klebsiella spp.,Klebsiella pneumoniae,Proteus species(indole-positive and indole-negative), Clostridium spp.and anaerobic gram-positive cocci. Infections of the Skin and Skin Structures caused by S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes,and P. aeruginosa. Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital Tract caused by N. gonorrhoeae, S. epidermidis,S. agalactiae, E. coli, Clostridium spp.,Bacteroides species (including Bacteroides fragilis), and anaerobic gram-positive cocci. Cefobid, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa. Enterococcal Infections: Although cefoperazone has been shown to be clinically effective in the treatment of infections caused by enterococci in cases of peritonitis and other intra-abdominal infections, infections of the skin and skin structures, pelvic inflammatory disease, endometritis and other infections of the female genital tract, and urinary tract infections,the majority of clinical isolates of enterococci tested are not susceptible to cefoperazone but fall just at or in the intermediate zone of susceptibility, and are moderately resistant to cefoperazone. However, in vitro susceptibility testing may not correlate directly with in vivo results. Despite this, cefoperazone therapy has resulted in clinical cures of enterococcal infections, chiefly in polymicrobial infections. Cefoperazone should be used in enterococcal infections with care and at doses that achieve satisfactory serum levels of cefoperazone.
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Cefobid
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