Ceftriaxone Apotex is used to treat bacterial infections in many different parts of the body. Ceftriaxone Apotex is also given before certain types of surgery to prevent infections.
Ceftriaxone Apotex belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Ceftriaxone Apotex will not work for colds, flu, or other virus infections.
Ceftriaxone Apotex is available only with your doctor's prescription.
Ceftriaxone Apotex indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Before instituting treatment with B Braun Ceftriaxone Apotex, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of B Braun Ceftriaxone Apotex and other antibacterial drugs, B Braun Ceftriaxone Apotex 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.
B Braun Ceftriaxone Apotex 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 spp.
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 Apotex 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 is 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 spp.
Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium spp (Note: Most strains of Clostridium difficile are resistant) or Peptostreptococcus spp.
Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae.
Ceftriaxone Apotex 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 10 infections.
Surgical Prophylaxis: The preoperative administration of a single 1 g dose of B Braun Ceftriaxone Apotex may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients eg, those >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 (eg, during coronary artery bypass surgery). Although Ceftriaxone Apotex 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 B Braun Ceftriaxone Apotex provides protection from most infections due to susceptible organisms throughout the course of the procedure.
How should I use Ceftriaxone Apotex?
Use Ceftriaxone Apotex exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Ceftriaxone Apotex is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.
You may need to mix Ceftriaxone Apotex with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Use only the diluent your doctor has recommended.
Do not mix Ceftriaxone Apotex in the same injection with other antibiotics, or with any diluent that contains calcium, including a TPN (total parenteral nutrition) solution.
After mixing your medicine, you will need to use it within a certain number of hours or days. This will depend on the diluent and how you store the mixture (at room temperature, in a refrigerator, or frozen). Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.
If you use other injectable medications, be sure to flush your intravenous catheter between injections of each medication.
Use Ceftriaxone Apotex for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ceftriaxone Apotex will not treat a viral infection such as the common cold or flu.
Ceftriaxone Apotex can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using this medicine.
Store unmixed Ceftriaxone Apotex powder at room temperature, away from moisture, heat, and light.
If your medicine was provided in a frozen form or was frozen after mixing, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Use the medicine as soon as possible after thawing it. Do not refreeze.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Uses of Ceftriaxone Apotex in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Bloodstream infection: Caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, or Klebsiella pneumoniae.
Bone and joint infections (osteomyelitis and/or discitis, prosthetic joint infection, septic arthritis): Caused by S. aureus, S. pneumoniae, E. coli, Proteus mirabilis, K. pneumoniae, or Enterobacter spp.
Gonococcal infection, uncomplicated (cervical/urethral, rectal, and pharyngeal): Caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of N. gonorrhoeae.
Intra-abdominal infection, community-acquired (mild to moderate infection in low-risk patients): Caused by E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium spp. (Note: Most strains of C. difficile are resistant), or Peptostreptococcus spp.
Lower respiratory tract infections (pneumonia, community-acquired): Caused by S. pneumoniae, S. aureus, H. influenzae, Haemophilus parainfluenzae, K. pneumoniae, E. coli, Enterobacter aerogenes, P. mirabilis, or Serratia marcescens.
Meningitis, bacterial: Caused by H. influenzae, Neisseria meningitidis, or S. pneumoniae. Ceftriaxone Apotex has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and E. coli (efficacy for these 2 organisms in this organ system was studied in fewer than 10 infections).
Otitis media, acute: Caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), or Moraxella catarrhalis (including beta-lactamase-producing strains).
Pelvic inflammatory disease (mild to moderate): Caused by N. gonorrhoeae. Ceftriaxone Apotex, 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 antichlamydial coverage should be added.
Skin and soft tissue infections: Caused by S. aureus, S. epidermidis, Streptococcus pyogenes, viridans group streptococci, E. coli, Enterobacter cloacae, Klebsiella oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii (efficacy for this organism in this organ system was studied in fewer than 10 infections), S. marcescens, Acinetobacter calcoaceticus, B. fragilis (efficacy for this organism in this organ system was studied in fewer than 10 infections), or Peptostreptococcus spp.
Surgical prophylaxis, colorectal: To reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated.
Urinary tract infection, complicated (including pyelonephritis): Caused by E. coli, P. mirabilis, Proteus vulgaris, M. morganii, or K. pneumoniae.
Off Label Uses
Actinomycosis, severe or extensive
Data from a limited number of patients suggest Ceftriaxone Apotex may be beneficial for the treatment of severe or extensive actinomycosis.
Ceftriaxone Apotex description
B Braun Ceftriaxone Apotex is a sterile, nonpyrogenic, single use, packaged combination of Ceftriaxone Apotex 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 Apotex sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for IV administration. Ceftriaxone Apotex 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-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate.
Its chemical formula is C18H16N8Na2O7S3·3.5H2O. It has a calculated molecular weight of 661.6.
Ceftriaxone Apotex sodium is supplied as a dry powder form equivalent to either 1 or 2 g of Ceftriaxone Apotex. It 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 Apotex sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration.
Ceftriaxone Apotex sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of Ceftriaxone Apotex 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.
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 IV use. When reconstituted, the approximate osmolality for the reconstituted solution for B Braun Ceftriaxone Apotex 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.
Ceftriaxone Apotex dosage
Intended for IV administration only.
B Braun Ceftriaxone Apotex and calcium-containing solutions, including continuous calcium-containing infusions eg, parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites.
Treatment of Skin and Skin Structure Infections: Recommended Total Daily Dose: 50-75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 g.
Treatment of Serious Miscellaneous Infections Other than Meningitis: Recommended Total Daily Dose: 50-75 mg/kg, given in divided doses every 12 hrs. The total daily dose should not exceed 2 g.
Treatment of Meningitis: Recommended Initial Therapeutic Dose: 100 mg/kg (not to exceed 4 g). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 g daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hrs). The usual duration of therapy is 7-14 days.
Adults: Usual Daily Dose: 1-2 g 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 g.
If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because Ceftriaxone Apotex sodium has no activity against this organism.
For preoperative use (surgical prophylaxis), a single dose of 1 g administered IV ½-2 hrs before surgery is recommended.
Generally, B Braun Ceftriaxone Apotex therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4-14 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.
Children: B Braun Ceftriaxone Apotex in the Duplex container is designed to deliver a 1 or 2 g dose of Ceftriaxone Apotex. To prevent unintentional overdose, B Braun Ceftriaxone Apotex should not be used in pediatric patients who require less than the full adult dose of Ceftriaxone Apotex.
Neonates: Hyperbilirubinemic neonates, especially prematures, should not be treated with B Braun Ceftriaxone Apotex.
Hepatic and Renal Impairment: 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 (eg, dialysis patients) and in patients with both renal and hepatic dysfunctions.
Administration: Directions for Use: B Braun Ceftriaxone Apotex should be administered IV by infusion over a period of 30 min.
Vancomycin, amsacrine, aminoglycosides and fluconazole are physically incompatible with Ceftriaxone Apotex in admixtures. When any of these drugs are to be administered concomitantly with Ceftriaxone Apotex by intermittent IV infusion, it is recommended that they be given sequentially, with thorough flushing of the IV lines (with one of the compatible fluids) between the administrations.
B Braun Ceftriaxone Apotex should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs due to possible incompatibility.
After the indicated stability time periods, unused portions of solutions should be discarded.
No impairment of renal function has so far been observed after concurrent administration of large doses of Ceftriaxone Apotex and potent diuretics (eg, furosemide). There is no evidence that Ceftriaxone Apotex increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of Ceftriaxone Apotex. Ceftriaxone Apotex does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. The elimination of Ceftriaxone Apotex is not altered by probenecid. In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and Ceftriaxone Apotex.
Do not use diluents containing calcium eg, Ringer's or Hartmann's solution, to reconstitute Ceftriaxone Apotex vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of Ceftriaxone Apotex-calcium can also occur when Ceftriaxone Apotex is mixed with calcium-containing solutions in the same IV administration line.
Ceftriaxone Apotex must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions eg, parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone Apotex and calcium-containing solutions may be administered sequentially of one another, if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord, blood demonstrated that neonates have an increased risk of precipitation of Ceftriaxone Apotex-calcium.
Based on literature reports, Ceftriaxone Apotex is incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
In patients treated with Ceftriaxone Apotex, the Coombs' test may in rare cases be false-positive. Ceftriaxone Apotex, like other antibiotics, may result in false-positive tests for galactosemia. Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with Ceftriaxone Apotex should be carried out enzymatically.
Ceftriaxone Apotex may adversely affect the efficacy of oral hormonal contraceptives.
Consequently, it is advisable to use supplementary (nonhormonal) contraceptive measures during treatment and in the month following treatment.
Incompatibilities: Solutions containing Ceftriaxone Apotex should not be mixed with or added to other agents. In particular, diluents containing calcium (eg, Ringer's or Hartmann's solution), should not be used to reconstitute Ceftriaxone Apotex vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Ceftriaxone Apotex must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, Ceftriaxone Apotex is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Post-Marketing: During the use of Ceftriaxone Apotex, the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed: Systemic Side Effects: Gastrointestinal complaints (about 2% of the cases): loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.
Hematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia. Isolated cases of agranulocytosis (<500/mm3) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.
Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, edema. Isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens Johnson syndrome or Lyell's Syndrome/toxic epidermal necrolysis) have been reported.
Other, Rare Side Effects: Headache and dizziness, symptomatic precipitation of Ceftriaxone Apotex calcium salt in the gallbladder, increase in liver enzymes, oliguria, increase in serum creatinine, genital mycosis, fever, shivering and anaphylactic or anaphylactoid reactions.
Interaction with Calcium: Two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of Ceftriaxone Apotex and calcium. Ceftriaxone Apotex concentrations up to 1 mM (in excess of concentrations achieved in vivo following administration of 2 grams Ceftriaxone Apotex infused over 30 minutes) were used in combination with calcium concentrations up to 12 mM (48 mg/dL). Recovery of Ceftriaxone Apotex from plasma was reduced with calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or 4 mM (16 mg/dL) or higher in neonatal plasma. This may be reflective of Ceftriaxone Apotex-calcium precipitation.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Ceftriaxone Apotex and calcium containing fluids. In some of these cases, the same intravenous infusion line was used for both Ceftriaxone Apotex and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Ceftriaxone Apotex and calcium-containing fluids were administered at different autopsy in this neonate. There have been no similar reports in patients other than neonates.
Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects.
Very rare cases of renal precipitation have been reported, mostly in children older than 3 years and who have been treated with either high daily doses (e.g. ≥80 mg/kg/day) or total doses exceeding 10 grams and presenting other risk factors (e.g. fluid restrictions, confinement to bed, etc.). This event may be symptomatic or asymptomatic, may lead to renal insufficiency, and is reversible upon discontinuation of Ceftriaxone Apotex.
Local Side Effects: In rare cases, phlebitis reactions occurred after i.v. administration. These may be minimized by slow (2-4 minutes) injection.
Intramuscular injection without lidocaine solution is painful.
Laboratory Abnormalities: Influence on Diagnostic Tests: In patients treated with Ceftriaxone Apotex the Coombs' test may rarely become false-positive.
Ceftriaxone Apotex, like other antibiotics, may result in false-positive tests for galactosemia.
Likewise, nonenzymatic methods for the glucose determination in urine may give false positive results. For this reason, urine-glucose determination during therapy with Ceftriaxone Apotex should be done enzymatically.
Hypersensitivity: Hypersensitivity to Ceftriaxone Apotex, any of excipients of Ceftriaxone Apotex or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other β-lactam agents may be at greater risk of hypersensitivity to Ceftriaxone Apotex.
Lidocaine: It must be excluded before IM injection of Ceftriaxone Apotex when lidocaine solution is used as a solvent. Ceftriaxone Apotex solutions containing lidocaine should never be administered IV.
Premature Neonates: Ceftriaxone Apotex is contraindicated in premature neonates up to postmenstrual age of 41 weeks (gestational age + chronological age).
Hyperbilirubinemic Newborns: Should not be treated with Ceftriaxone Apotex. In vitro studies have shown that Ceftriaxone Apotex can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.
Neonates and Calcium-Containing IV Solutions: Ceftriaxone Apotex is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions eg, parenteral nutrition because of the risk of precipitation of Ceftriaxone Apotex-calcium.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Ceftriaxone Apotex and calcium-containing fluids. In some of these cases, the same IV infusion line was used for both Ceftriaxone Apotex and calcium-containing fluids and in some a precipitate was observed in the IV infusion line. At least 1 fatality has been reported in a neonate in whom Ceftriaxone Apotex and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.
DailyMed. "CEFTRIAXONE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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