To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and other antibacterial drugs, Ceftriaxone for 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 absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for Injection is indicated for the treatment of the following infections when caused by susceptible bacteria: Ceftriaxone for Injection, USP is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower Respiratory Tract Infections ( 1.1 ); Skin and Skin Structure Infections ( 1.2 ); Complicated and Uncomplicated Urinary Tract Infections ( 1.3 ); Pelvic Inflammatory Disease ( 1.4 ); Bacterial Septicemia ( 1.5 ); Bone and Joint infections ( 1.6 ); Intra-abdominal Infections ( 1.7 ); Meningitis ( 1.8 ); and Surgical Prophylaxis ( 1.9 ).
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 The efficacy for these organisms in this organ system were studied in fewer than ten infections. , Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species.
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Complicated and Uncomplicated Urinary Tract Infections Complicated
and uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae .
1.4Pelvic Inflammatory Disease
Pelvic inflammatory disease caused by Neisseria gonorrhoeae . Ceftriaxone 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.
1.5Bacterial Septicemia
Bacterial septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae .
1.6Bone and Joint Infections Bone
and joint infections caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.
1.7Intra-abdominal Infections
Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species or Peptostreptococcus species.
1.8Meningitis
Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae . Ceftriaxone sodium has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and Escherichia coli ; however, the efficacy for these organisms in this organ system were studied in fewer than ten infections.
1.9Surgical Prophylaxis
The preoperative administration of a single 1 gram dose of ceftriaxone 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 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 antibacterial in the prevention of infection following coronary artery bypass surgery.
Gegenanzeigen
Anaphylaxis to ceftriaxone or other cephalosporin class antibacterials, penicillins or other beta-lactam antibacterials ( 4.1 )
4.1 Anaphylaxis to Ceftriaxone or the Cephalosporin Class of Antibacterials, Penicillins or Other Beta-Lactam Antibacterials Ceftriaxone for Injection, USP is contraindicated in patients who have a history of anaphylaxis to ceftriaxone or the cephalosporin class of antibacterials, penicillins, or other beta-lactam antibacterials [see Warnings and Precautions (5.1) ].
Warnhinweise und Vorsichtsmaßnahmen
Hypersensitivity reactions: Include anaphylaxis and serious skin reactions. Cross hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug ( 5.1 ). Interaction with Calcium-containing products: Precipitation can occur. Do not administer simultaneously with calcium-containing I.V. solutions ( 5.2 ). Neurological adverse reactions: Serioous neurological adverse reactions have been reported during postmarketing surveillance.
If serious adverse reactions occur, discontinue the drug and institute appropriate supportive measures. ( 5.3 ) Clostridium difficile -associated diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs ( 5.4 ). Hemolytic Anemia: Severe cases of hemolytic anemia, including fatalities in adults and children, have been reported. If anemia is diagnosed, discontinue the drug until the etiology is determined.
( 5.5 )
5.1Hypersensitivity Reactions to Ceftriaxone, Cephalosporins, Penicillins or Other Drugs
Serious, occasionally fatal, hypersensitivity (anaphylactic) reactions have been reported with ceftriaxone. Before therapy with Ceftriaxone for Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to ceftriaxone, cephalosporins, penicillins, or other drugs. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterials has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to Ceftriaxone for Injection, USP occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.
5.2Interaction with Calcium-Containing Products Precipitation
of ceftriaxone-calcium can occur when Ceftriaxone for Injection, USP is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions, such as parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone for Injection, USP and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with 0.9% Sodium Chloride Injection or D5W.
In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium. [see Drug Interactions ( 7.2 ) ]
5.3Neurological Adverse Reactions
Serious neurological adverse reactions have been reported during postmarketing surveillance with ceftriaxone use. These reactions include encephalopathy (disturbances of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus [see Adverse Reactions ( 6.2 ) ]. Some cases occurred in patients with severe renal impairment who did not receive appropriate dosage adjustment.
However, in other cases, neurological adverse reactions occurred in patients receiving an appropriate dosage adjustment. The neurological adverse reactions were reversible and resolved after discontinuation. If neurological adverse reactions associate with Ceftriaxone for Injection therapy occur, discontinue Ceftriaxone for Injection and institute appropriate supportive measures. Make appropriate dosage adjustments in patients with severe renal impairment. [see Dosage and Administration ( 2.1 ) ]. 5.4 Clostridium difficile- associated Diahrrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftriaxone, 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 . 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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.5Hemolytic Anemia
An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including ceftriaxone. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on Ceftriaxone for Injection, USP, the diagnosis of a cephalosporin-associated anemia should be considered and Ceftriaxone for Injection, USP stopped until the etiology is determined.
5.6Gallbladder Sonogram Abnormalities
There have been reports of sonographic abnormalities in the gallbladder of patients treated with ceftriaxone sodium; 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-calcium salt.
The condition appears to be transient and reversible upon discontinuation of ceftriaxone sodium and institution of conservative management. Therefore, ceftriaxone should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.
5.7Patients with Hepatic and Renal Impairment Hepatic Impairment:
In patients with both hepatic and significant renal disease, Ceftriaxone for Injection dosage should not exceed 2 grams daily. Renal Impairment: This formulation of Ceftriaxone for Injection USP – Pharmacy Bulk Package bags SmartPak ® should not be used in renally impaired patients who require less than the 1 gram dose of ceftriaxone. In patients with both hepatic impairment and significant renal disease, Ceftriaxone for Injection dosage should not exceed 2 grams per day.
5.8Pancreatitis Cases
of pancreatitis, possibly secondary to biliary obstruction, have been reported in patients treated with ceftriaxone sodium. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, total parenteral nutrition). A cofactor role of ceftriaxone-related biliary precipitation cannot be ruled out.
5.9 Development of Drug-Resistant Bacteria Prescribing Ceftriaxone for Injection, USP 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. As with other antibacterial drugs, use of Ceftriaxone for 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.
5.10Alterations in Prothrombin Time Alterations
in prothrombin times have occurred in patients treated with ceftriaxone sodium. Patients w
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Wechselwirkungen
Vancomycin, amsacrine, aminoglycosides and fluconazole are physically incompatible. ( 7.1 ) Calcium-containing products: precipitation can occur. ( 7.2 )
7.1Vancomycin, Amsacrine, Aminoglycosides, and Fluconazole
Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures [see Dosage and Administration (2.3) ].
7.2Calcium-containing Products Precipitation
of ceftriaxone-calcium can occur when Ceftriaxone for Injection is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection, USP must not be administered simultaneously with calcium-containing intravenous solutions. Ceftriaxone for Injection and calcium-containing solutions can be administered sequentially [see Warnings and Precautions (5.2) ]
Schwangerschaft und Stillzeit
8.1Pregnancy Pregnancy Category B.
Reproductive studies have been performed in mice, rats, and primates at intravenous doses of 625, 586, and 84 mg/kg/day, respectively without evidence of embryotoxicity, fetotoxicity, or teratogenicity. These doses are approximately 1.5, 2.8, and 0.8 times the recommended clinical dose of 2 grams/day based on body surface area comparisons. 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. Ceftriaxone was tested in a Segment III (pre-postnatal) study in rats at intravenous doses of up to 586 mg/kg/day approximately 2.8 times (mg/m 2 comparison) the recommended daily dose of 2 grams/day. No adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior, and reproductive ability of the offspring.
Nebenwirkungen
The following serious adverse reactions to ceftriaxone are described below and elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1) ] Ceftriaxone-calcium precipitates [see Warnings and Precautions (5.2) and Drug Interactions (7.2) ] Clostridium difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Hemolytic anemia [see Warnings and Precautions (5.4) ] The most common adverse reactions occurring in >2% of patients receiving ceftriaxone include diarrhea, eosinophilia, thrombocytosis, leukopenia, and elevations of SGOT and SGPT.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Samson Medical Technologies, L.L.C. at 1-877-418-3600 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reactions occurred in ≤ 6% of the patients: Local reactions – pain, induration, tenderness, and phlebitis after intravenous administration. Hypersensitivity – rash, pruritus, fever or chills.
Hematologic – eosinophilia, thrombocytosis, leukopenia, anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia, and prolongation of the prothrombin time. Gastrointestinal – diarrhea, nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.4 ) ]. Hepatic – elevations of SGOT, SGPT, alkaline phosphatase, bilirubin.
Renal – elevations of the BUN, creatinine, and the presence of casts in the urine. Central Nervous System – headache or dizziness. Genitourinary – moniliasis or vaginitis. Miscellaneous – diaphoresis and flushing. Ceftriaxone-calcium precipitates – Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 ) ].
Other observed adverse reactions - 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. inner bag
6.2Postmarketing Experience
The following adverse reactions have been reported during postapproval use of ceftriaxone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure. Neurologic-Encephalopathy, seizures, myoclonus, and non-convulsive status epilepti us [see Warnings and Precautions ( 5.3 )] Gastrointestinal – stomatitis and glossitis Genitourinary – oliguria Dermatologic – exanthema, allergic dermatitis, urticaria, edema Cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported.
Anaphylaxis (including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia) has been reported.
6.3Cephalosporin-class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with ceftriaxone, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterials: Adverse Reactions: Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and superinfection.
Altered Laboratory Tests: Positive direct Coombs’ test, false-positive test for urinary glucose, and elevated LDH.
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