Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4154
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Cefotaxime and Dextrose (Injection)
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This product is intended for intravenous administration only.<br/>Adults:<br/>Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function . Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for Injection USP and Dextrose Injection is intended for IV administration after reconstitution. The maximum daily dosage should not exceed 12grams. To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IV administered 30 to 90 minutes prior to start of surgery.<br/>Cesarean Section Patients: The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously at 6 and 12 hours after the first dose.<br/>Pediatric Patients: For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams. Cefotaxime for Injection USP and Dextrose Injection in the DUPLEX Container is designed to deliver 1 g or 2 g dose of cefotaxime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of cefotaxime.<br/>Impaired Renal Function: see PRECAUTIONS section. NOTE: As with antibiotic therapy in general, administration of cefotaxime should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>DUPLEX Drug Delivery System Directions for Use: Removal from Multi-Pack Tray Patient Labeling and Drug Powder/Diluent Inspection Reconstitution (Activation) Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration. Administration Precautions
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Cefotaxime for Injection USP and Dextrose Injection is a sterile, nonpyrogenic, single use, packaged combination of Cefotaxime Sodium and Dextrose Injection (diluent) in the DUPLEX sterile container. The DUPLEX Container is a flexible dual chamber container. The drug chamber is filled with sterile Cefotaxime Sodium USP, a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0]
oct-2-ene-2-carboxylate 7(Z)-(o-methyloxime), acetate (ester). The CAS Registry Number is 64485-93-4. Cefotaxime Sodium has the following structural formula: The empirical formula of Cefotaxime Sodium is CHNNaOS, representing a molecular weight of 477.45. Cefotaxime Sodium contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. The diluent chamber contains Dextrose Injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula: The molecular weight of Hydrous Dextrose USP is 198.17. Cefotaxime Sodium is supplied as a dry powder form equivalent to either 1 g or 2 g of cefotaxime. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 1.95 g and 1.2 g to 1 g and 2 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the
approximate osmolality for the reconstituted solution for Cefotaxime for Injection USP and Dextrose Injection is 290 mOsmol/kg. The DUPLEX dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.
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There was a dose-dependent increase in serum levels after the IV administration of 500 mg, 1 g, and 2 g of cefotaxime (38.9, 101.7, and 214.4��g/mL respectively) without alteration in the elimination half-life. There is no evidence of accumulation following repetitive IV infusion of 1 g doses every 6 hours for 14 days as there are no alterations of serum or renal clearance. About 60% of the administered dose was recovered from urine during the first 6 hours following the start of the infusion. Approximately 20���36% of an intravenously administered dose ofC-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15���25% as the desacetyl derivative, the major metabolite. The desacetyl metabolite has been shown to contribute to the bactericidal activity. Two other urinary metabolites (Mand M) account for about 20���25%. They lack bactericidal activity. A single 50 mg/kg dose of cefotaxime was administered as an intravenous infusion over a 10- to 15- minute period to 29 newborn infants grouped according to birth weight and age. The mean half-life of cefotaxime in infants with lower birth weights (���1500 grams), regardless of age, was longer (4.6 hours) than the mean half-life (3.4 hours) in infants whose birth weight was greater than 1500 grams. Mean serum clearance was also smaller in the lower birth weight infants. Although the differences in mean half-life values are statistically significant for weight, they are not clinically important. Therefore, dosage should be based solely on age. Additionally, no disulfiram-like reactions were reported in a study conducted in 22 healthy volunteers administered cefotaxime and ethanol.<br/>Microbiology: The bactericidal activity of cefotaxime sodium results from inhibition of cell wall synthesis. Cefotaxime sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. Cefotaxime sodium has a high degree of stability in the presence of��-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Cefotaxime sodium has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Aerobes, Gram-positive: Enterococcus spp.Staphylococcus aureus, including��-lactamase-positive and negative strainsStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus pyogenes (Group A beta-hemolytic streptococci)Streptococcus spp. Aerobes, Gram-negative: Acinetobacter spp.Citrobacter spp.Enterobacter spp.Escherichia coliHaemophilus influenzae (including ampicillin-resistant strains)Haemophilus parainfluenzaeKlebsiella spp. (including Klebsiella pneumoniae)Morganella morganiiNeisseria meningitidisProteus mirabilisProteus vulgarisProvidencia rettgeriProvidencia stuartiiSerratia marcescens NOTE: Many strains of the above organisms that are multiply resistant to other antibiotics, e.g. penicillins, cephalosporins, and aminoglycosides, are susceptible to cefotaxime sodium. Cefotaxime sodium is active against some strains of Pseudomonas aeruginosa. Anaerobes: Bacteroides spp., including some strains of Bacteroides fragilisClostridium spp. (Note: Most strains of Clostridium difficile are resistant.)Fusobacterium spp. (including Fusobacterium nucleatum).Peptococcus spp.Peptostreptococcus spp. Cefotaxime sodium also demonstrates in vitro activity against the following microorganisms but the clinical significance is unknown. Cefotaxime sodium exhibits in vitro minimal inhibitory concentrations (MIC's) of 8��g/mL or less against most (���90%) strains of the following microorganisms; however, the safety and effectiveness of cefotaxime sodium in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials: Aerobes, Gram-negative: Providencia spp.Salmonella spp. (including Salmonella typhi)Shigella spp. Cefotaxime sodium is highly stable in vitro to four of the five major classes of��-lactamases described by Richmond et al., including type IIIa (TEM) which is produced by many gram-negative bacteria. The drug is also stable to��-lactamase (penicillinase) produced by staphylococci. In addition, cefotaxime sodium shows high affinity for penicillin-binding proteins in the cell wall, including PBP: Ib and III. Cefotaxime sodium and aminoglycosides have been shown to be synergistic in vitro against some strains of Pseudomonas aeruginosa but the clinical significance is unknown.<br/>Susceptibility Tests:
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Cefotaxime for Injection USP and Dextrose Injection is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium or the cephalosporin group of antibiotics. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
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Cefotaxime for Injection USP and Dextrose Injection in the DUPLEX Drug Delivery System is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g cefotaxime. The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose Injection has been adjusted to 3.9% and 2.4% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic. Cefotaxime for Injection USP and Dextrose Injection is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System Containers packaged 12 units per tray, 2 trays per case. Store the unactivated unit at 20���25��C (68���77��F). Excursions permitted to 15���30��C (59���86��F).
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Cefotaxime sodium and Dextrose monohydrate
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Cefotaxime and Dextrose (Injection)
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Cefotaxime is generally well tolerated. The most common adverse reactions have been local reactions following IV injection. Other adverse reactions have been encountered infrequently. The most frequent adverse reactions (greater than 1%) are: Less frequent adverse reactions (less than 1%) are:<br/>Cephalosporin Class Labeling: In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
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Treatment: Cefotaxime for Injection USP and Dextrose Injection is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Although many strains of enterococci (e.g., E. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime is used concomitantly with an aminoglycoside.<br/>Prevention: The administration of cefotaxime preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, cefotaxime should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotaxime for Injection USP and Dextrose Injection and other antibacterial drugs, Cefotaxime for Injection USP and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absenceof such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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Cefotaxime and Dextrose
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