Drug: Ceftriaxone

Ceftriaxone for Injection and Dextrose Injection (ceftriaxone sodium and dextrose injection ) is a sterile, nonpyrogenic, single use, packaged combination of Ceftriaxone 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 ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous administration. Ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium is (6R,7R)-7-[2-(2- Amino-4-thiazolyl)glyoxylamido]-8-oxo-3- [[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3- yl)thio]methyl] -5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacid,72-(Z)-(0-methyloxime), disodium salt, sesquaterhydrate. Ceftriaxone Sodium has the following structural formula: The chemical formula of ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium is C18H16N8Na207S3•3.5H20, representing a molecular weight of 661.60. Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium is supplied as a dry powder form equivalent to either..1 g or 2 g of ceftriaxone. Ceftriaxone Sodium is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone Sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration. Ceftriaxone Sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone (ceftriaxone sodium and dextrose injection ) 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 USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). 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. 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 Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) is 290 mOsmol/kg. The DUPLEX Container is Latex-free, PVC-free, and DEHP-free. 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.Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium therapy or of uncertain etiology, were observed: LOCAL REACTIONS — Phlebitis was reported in < 1% after IV administration. HYPERSENSITIVITY — rash (1.7%). Less frequently reported ( < 1 %) were pruritus, fever or chills. HEMATOLOGIC — eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported ( < 1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time. GASTROINTESTINAL — diarrhea (2.7%). Less frequently reported ( < 1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). HEPATIC — elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported ( < 1%) were elevations of alkaline phosphatase and bilirubin. RENAL — elevations of the BUN (1.2%). Less frequently reported ( < 1 %) were elevations of creatinine and the presence of casts in the urine. CENTRAL NERVOUS SVSTEM — headache or dizziness were reported occasionally ( < 1%). GENITOURINARY — moniliasis or vaginitis were reported occasionally ( < 1 %). MISCELLANEOUS — diaphoresis and flushing were reported occasionally ( < 1%). Other rarely observed adverse reactions ( < 0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness. Read the Ceftriaxone (ceftriaxone sodium and dextrose injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Ceftriaxone Injection and Dextrose Injection is intended for intravenous administration only. ADULTS: The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 grams. If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium has no activity against this organism. For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended. PEDIATRIC PATIENTS: Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftriaxone (ceftriaxone sodium and dextrose injection ) . To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftriaxone (ceftriaxone sodium and dextrose injection ) . For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should.not exceed 2 grams. For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams. In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days. Generally, Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days. No dosage adjustment is necessary for patients with impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal impairment [e.g., dialysis patients) and in patients with both renal and hepatic dysfunctions. Vancomycin and fluconazole are physically incompatible with ceftriaxone (ceftriaxone sodium and dextrose injection ) in admixtures. When either of these drugs is to be administered concomitantly with ceftriaxone (ceftriaxone sodium and dextrose injection ) by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations. After the indicated stability time periods, unused portions of solutions should be discarded. CAUTION: Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. NOTE: Parenteral drug products should be inspected visually for particulate matter before administration. Directions for Use of DUPLEX® Drug Delivery System Removal from Multi-Pack Tray
  • Tear tape strips from one or both sides of the tray. Remove top tray.
  • To avoid inadvertent activation, DUPLEX Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
  • Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label.
  • Unlatch side tab and unfold DUPLEX Container. (See Diagram 1.)
  • Visually inspect diluent chamber for particulate matter.
  • Use only if container and seals are intact.
  • To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.)
  • Protect.from light after removal of foil strip.
    • Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
  • The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
  • Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
  • Unfold the DUPLEX Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.)
  • Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration. Administration
  • Visually inspect the reconstituted solution for particulate matter.
  • Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.)
  • Prior to' attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired.
  • Using aseptic technique, remove the set port cover from the set port and attach sterile administration set.
  • Refer to Directions for Use accompanying the administration set.
Precautions
  • As with other cephalosporins, reconstituted Ceftriaxone (ceftriaxone sodium and dextrose injection ) for Injection and Dextrose Injection tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.
  • Use only if prepared solution is clear and free from particulate matter.
  • Do not use in series connection.
  • Do not introduce additives into the DUPLEX Container.
  • Do not freeze.
Animal Pharmacology Concretions consisting of the precipitated calcium salt of ceftriaxone (ceftriaxone sodium and dextrose injection ) have been found in the gallbladder bile of dogs and baboons treated with ceftriaxone (ceftriaxone sodium and dextrose injection ) . These appeared as a gritty sediment in dogs that received 100 mg/kg/day for 4 weeks. A similar phenomenon has been observed in baboons but only after a protracted dosing period (6 months) at higher dose levels (335 mg/kg/day or more). The likelihood of this occurrence in humans is considered to be low, since ceftriaxone (ceftriaxone sodium and dextrose injection ) has a greater plasma half-life in humans, the calcium salt of ceftriaxone (ceftriaxone sodium and dextrose injection ) is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and Dextrose Injection and other antibacterial drugs 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 absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, * Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis*and Escherichia coli.* ' * Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone (ceftriaxone sodium and dextrose injection ) for Injection and. Dextrose Injection may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years.of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) provides protection from most infections due to susceptible organisms throughout the course of the procedure. Before instituting treatment with Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) , appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility tothe drug. Therapy may be instituted prior to obtaining results of susceptibility testing.

Source: http://www.rxlist.com

Ceftriaxone for Injection and Dextrose injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.

Source: http://www.rxlist.com

Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium 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 ceftriaxone (ceftriaxone sodium and dextrose injection ) . The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose injection has been adjusted to 3.74% and 2.22% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic. Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 12 units per tray, 2 trays per case. NDG Cat. No. Dose Volume Ceftriaxone for Injection and Dextrose Injection 0264-3153-11 3153-11 1g 50 mL Ceftriaxone for Injection and Dextrose Iniection 0264-3155-11 3155-11 2g 50 mL Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). DUPLEX® is a registered trademark of B. Braun Medical Inc. Revised: January 2007 B. Braun Medical Inc. Irvine, CA, USA 92614-5895. FDA Rev date: 9/10/2007 Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Prescribing Ceftriaxone for Injection and Dextrose Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Although transient elevations of BUN and serum creatinine have been observed, at the recommended dosages, the nephrotoxic potential of Ceftriaxone (ceftriaxone sodium and dextrose injection ) is similar to that of other cephalosporins. Ceftriaxone is excreted via both biliary and renal excretion (see CLINICAL PHARMACOLOGY). Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of Ceftriaxone (ceftriaxone sodium and dextrose ) for Injection are administered, but concentrations of drug in the serum should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly. Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, Ceftriaxone for Injection and Dextrose Injection dosage should not exceed 2 g daily without close monitoring of serum concentrations. Alterations in prothrombin times have occurred rarely in patients treated with Ceftriaxone (ceftriaxone sodium and dextrose) Injection. Patients with impaired vitamin K synthesis or low vitamin K stores (e.g., chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy. Prolonged use of Ceftriaxone for Injection and Dextrose Injection may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Ceftriaxone for Injection and Dextrose Injection should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis. There have been reports of sonographic abnormalities in the gallbladder of patients treated with Ceftriaxone (ceftriaxone sodium and dextrose) Injection; some of these patients also had symptoms of gallbladder disease. These abnormalities appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. The chemical nature of the sonographically detected material has been determined to be predominantly a ceftriaxone (ceftriaxone sodium and dextrose) Injection -calcium salt. The condition appears to be transient and reversible upon discontinuation of Ceftriaxone (ceftriaxone sodium and dextrose) Injection and institution of conservative management. Therefore, Ceftriaxone (ceftriaxone sodium and dextrose) Injection should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above. As with other dextrose-containing solutions, Ceftriaxone for Injection and Dextrose Injection should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Use only if solution is clear and container and seals are intact. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Considering the maximum duration of treatment and the class of the compound, carcinogenicity studies with Ceftriaxone (ceftriaxone sodium and dextrose) Injection in animals have not been performed. The maximum duration of animal toxicity studies was 6 months. Mutagenesis: Genetic toxicology tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in w'frowith ceftriaxone showed no potential for mutagenic activity in these studies. Impairment of Fertility: Ceftriaxone produced no impairment of fertility when given intravenously to rats at daily doses up to 586 mg/kg/day, approximately 20 times the recommended clinical dose of 2 g/day. Pregnancy:Teratogenic Effects: Pregnancy Category B. Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects: In rats, in the Segment I (fertility and general reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered ceftriaxone, no adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior and reproductive ability of the offspring, at doses of 586 mg/kg/day or less. Nursing Mothers Low concentrations of ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a nursing woman. Pediatric Use Ceftriaxone in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftriaxone. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftriaxone . Safety and effectiveness of Ceftriaxone in neonates, infants and pediatric patients have been established for the dosages described in the DOSAGE AND ADMINISTRATION section. In vitro studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone should not be administered to hyperbilirubinemic neonates, especially prematures. Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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