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CEFTRIAXONE FOR is a brand name for Ceftriaxone, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ceftriaxone for Injection is indicated for the treatment of the following infections when caused by susceptible strains of the designated micro-organisms: • Lower Respiratory tract infections caused by E. coli, H. influenzae, K. pneumoniae and species, Staph. aureus, Strep. pneumoniae and species (excluding…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Ceftriaxone for Injection (ceftriaxone sodium) may be administered intravenously or intramuscularly after reconstitution. Dosage and route of administration should be determined by the severity of infection, susceptibility of the causative organisms, and condition of the patient.
The intravenous route is preferable for patients with septicemia or other severe or life-threatening infections. 5 or 1 g q12h 1 or 2 g Ceftriaxone for Injection – Product Monograph Page 6 of 59 Type of Infection Route Dose Frequency Total Daily Dose There is limited experience with daily dose of 3 - 4 g administered as a single dose or two equally divided doses.
The total daily dose should not exceed 4 g. 5 mg/kg q12h 50 or 75 mg/kg The total daily dose should not exceed 2 g. If body weight is 50 kg or more, the adult dose should be used. Meningitis intravenous or intramuscular 50 mg/kg* q12h 100 mg/kg * With or without a loading dose of 75 mg/kg.
The total daily dose should not exceed 4 g. With the exception of gonorrhea, which is treated with a single dose, the administration of Ceftriaxone for Injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained, usually 4 to 14 days.
In bone and joint infections, the average duration of treatment during clinical trials was 6 weeks, with a range of 1 to 13 weeks, depending on the severity of the infection. When treating infections caused by beta hemolytic streptococcus, it is recommended that therapy be continued for at least 10 days.
The average duration of therapy for infections associated with beta hemolytic streptococcus during clinical trials was 2 weeks, with a range of 1 to 5 weeks, depending on the site and severity of the infection. Prophylaxis (Vaginal or Abdominal Hysterectomy, Coronary Artery Bypass Surgery, Biliary Tract Surgery): For preoperative use as prophylaxis before vaginal or abdominal hysterectomy, coronary artery bypass surgery, or biliary tract surgery in patients at risk of infection, a single dose of 1 g administered 30 minutes to 2 hours before surgery is recommended.
Impairment of Renal and/or Hepatic Function:
In patients with mild to moderate renal impairment, changes in the dosage regimen are not required, provided liver function is not impaired. In cases of preterminal renal failure (creatinine clearance less than 10 mL/min), periodic monitoring of serum ceftriaxone concentrations is recommended.
1 Adverse Reaction Overview The most commonly reported adverse reactions are Severe Cutaneous Adverse Reactions, Clostridium Difficile-Associated Disease, Hemolytic Anemia and Renal and Hepatic Impairment (see WARNINGS AND PRECAUTIONS).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful for identifying and approximating rates of adverse drug reactions in real-world use. 1 - 1%); urticaria (post-marketing reports). Isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens Johnson Syndrome, or Lyell’s Syndrome/toxic epidermal necrolysis) have also been reported.
1%); immune hemolytic anemia (post-marketing reports - see WARNINGS AND PRECAUTIONS for more information on hemolytic anemia); granulocytopenia (post-marketing reports). 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.
1%). 1 - 1%); oliguria and nephrolithiasis (post-marketing reports). 1%); glossitis (post- marketing reports). 1%). 1%); glottic/laryngeal edema (post- marketing reports). 1%). a Pain on intramuscular injection is usually mild and less frequent when the drug is administered in sterile 1% Lidocaine solution.
1%). 1 - 1%). 1%). b Incidence is more frequent in patients less than one year old. c Incidence is more frequent in patients less than one year old and over 50 years old. 5 Post-Market Adverse Reactions 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 sodium and calcium-containing fluids.
, General, Severe Cutaneous Adverse Reactions 01/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment .........................................................
3 Reconstitution ........................................................................................................... 4 Administration ...........................................................................................................
8 5 OVERDOSAGE........................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................
Ceftriaxone for Injection is contraindicated in • patients with known hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. other cephalosporins, or penicillins (see WARNINGS AND PRECAUTIONS).
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Hyperbilirubinemic neonates and preterm neonates should not be treated with ceftriaxone. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin leading to a possible risk of bilirubin encephalopathy in these patients (see WARNINGS AND PRECAUTIONS).
• neonates (≤ 28 days old) if they require (or are expected to require) treatment with calcium- containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, PHARMACEUTICAL INFORMATION and CLINICAL PHARMACOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The daily dosage should be limited to 2 g or less. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is not Ceftriaxone for Injection – Product Monograph Page 7 of 59 impaired. In cases of coexistent renal and clinically significant hepatic insufficiency, close monitoring of serum ceftriaxone concentrations, at regular intervals, is recommended.
If there is evidence of accumulation, dosage should be decreased accordingly. 35 *Shake well until dissolved.
Note:
Solutions prepared for intramuscular use or any solution containing Lidocaine or Bacteriostatic Water for Injection should never be administered intravenously. For Intravenous Use Reconstitute only with Sterile Water for Injection. 1 **Shake well until dissolved.
The prepared solution may be further diluted to the desired volume with any of the “Solutions for Intravenous Infusion” listed below. 9% Sodium Chloride Injection Pharmacy Bulk Vial Reconstitution for Preparation of Intravenous Infusion Solutions The closure of the pharmacy bulk vial shall be penetrated only one time after reconstitution, using a suitable sterile transfer device or dispensing set which allows measured dispensing for the contents.
THE USE OF PHARMACY BULK VIALS IS RESTRICTED TO HOSPITALS WITH A RECOGNIZED INTRAVENOUS ADMIXTURE PROGRAM. 1 Shake well until dissolved. Withdraw the required amount and dilute with one of the “Solutions for intravenous Infusion”. Any unused solution remaining within a period of 8 hours should be discarded.
4 Administration Intramuscular: The reconstituted solution of Ceftriaxone for Injection should be administered by deep intragluteal injection. It is recommended that not more […]
In some of these cases, the same intravenous infusion line was used for both ceftriaxone sodium 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 sodium 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. Serious post-market cases of encephalopathy (also reported as altered mental status, delirium, confusion, disturbance of consciousness, disorientation, agitation, hallucinations) have been reported.
These cases can be accompanied by myoclonus and other movement disorders (including tremor and choreoathetosis). In the majority of cases, symptoms of neurotoxicity resolved after discontinuation of ceftriaxone. Many cases were reported in patients with renal impairment.
The maximum daily dose in patients with a creatinine clearance less than 10 mL/min should not exceed 2 g.
1 Special Populations ................................................................................................. 1 Pregnant Women ...............................................................................................
2 Breast-feeding .................................................................................................... 3 Pediatrics ............................................................................................................
4 Geriatrics ............................................................................................................ 14 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions............................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Ceftriaxone for Injection – Product Monograph Page 3 of 59 Quantitative Data ....................................................................................................
5 Post-Market Adverse Reactions .............................................................................. 15 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview ....................................................................................
4 Drug-Drug Interactions............................................................................................ 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................... 17 10 CLINICAL PHARMACOLOGY .......................................................................................
2 Pharmacodynamics ................................................................................................. 3 Pharmacokinetics ....................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 33 PART II: SCIENTIFIC INFORMATION ......................................................................................
35 13 PHARMACEUTICAL INFORMATION ........................................................................... 35 14 CLINICAL TRIALS .......................................................................................................
35 15 MICROBIOLOGY ....................................................................................................... 36 16 NON-CLINICAL TOXICOLOGY .....................................................................................
46 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 53 PATIENT MEDICATION INFORMATION ................................................................................. 54 Ceftriaxone for Injection – Product Monograph Page 4 of 59 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Ceftriaxone for Injection is indicated for the treatment of the following infections when caused by susceptible strains of the designated micro-organisms: • Lower Respiratory tract infections caused by E.
coli, H. influenzae, K. pneumoniae and species, Staph. aureus, Strep. pneumoniae and species (excluding enterococci). • Urinary tract infections (complicated and uncomplicated) caused by E. coli, Klebsiella species, P. mirabilis and P. […]