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CEFTRIAXONE is a brand name for Ceftriaxone, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ceftriaxone Injection, USP 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.
). 2 Geriatrics Geriatrics: There is no known evidence to suggest that use in the geriatric population is associated with differences in safety or effectiveness. 2 CONTRAINDICATIONS Ceftriaxone Injection, USP 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 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see
, 4 DOSAGE AND Ceftriaxone Injection, USP Page 6 of 60 ADMINISTRATION, 13 PHARMACEUTICAL INFORMATION and 10 CLINICAL PHARMACOLOGY). 1 Dosing Considerations Ceftriaxone Injection, USP is administered intravenously. 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 There is limited experience with daily doses 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 Intravenously 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. Ceftriaxone Injection, USP Page 7 of 60 With the exception of gonorrhea, which is treated with a single dose, the administration of Ceftriaxone Injection, USP 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 1/2 to 2 hours before surgery is recommended.
). For a complete listing, see 6 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 7 WARNINGS AND PRECAUTIONS).
• Neonates (≤ 28 days old) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone -calcium (see 7 WARNINGS AND PRECAUTIONS,
Ceftriaxone Injection, USP 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 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see 6 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 7 WARNINGS AND PRECAUTIONS).
• Neonates (≤ 28 days old) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone -calcium (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS, 4 DOSAGE AND Ceftriaxone Injection, USP Page 6 of 60 ADMINISTRATION, 13 PHARMACEUTICAL INFORMATION and 10 CLINICAL PHARMACOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ceftriaxone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
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 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. 4 Administration Ceftriaxone Injection, USP is for intravenous administration using sterile equipment. It should be administered intravenously by infusion over a period of 30 minutes.
Do not add supplementary medication.
NOTE:
Ceftriaxone Injection, USP solution should not be physically mixed with aminoglycoside antibiotics nor administered at the same site because of possible chemical incompatibility. There have also been literature reports of physical incompatabilities between ceftriaxone and vancomycin, amsacrine, or fluconazole.
Precipitation of ceftriaxone calcium can also occur when Ceftriaxone Injection, USP is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone Injection, USP Ceftriaxone Injection, USP Page 8 of 60 must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site.
However, in patients other than neonates, Ceftriaxone Injection, USP and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
DIRECTIONS FOR USE Thawing of Plastic Container Thaw frozen container at room temperature (15 - 25°C) or under refrigeration (3 - 7°C). 5 hours Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.
Do not add supplementary medication. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation.
Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted, or if any seals are not intact, the container should be discarded.
The thawed solution is stable for 21 days under refrigeration (3 - 7°C) or 48 hours at room temperature (15 - 25°C). Do not refreeze thawed antibiotics.
Caution:
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is […]