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CEFTRIAXONE SODIUM 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 Sodium for Injection BP 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 Sodium For Injection BP 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 ADMINISTRATION, 13 PHARMACEUTICAL INFORMATION and 10 CLINICAL PHARMACOLOGY). 1 Dosing Considerations Ceftriaxone Sodium for Injection BP Page 6 of 58 Ceftriaxone Sodium For Injection BP 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.
V. M. 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. M . V. M. The total daily dose should not exceed 2 g. If body weight is 50 kg or more the adult dose should be used.
V. M. *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 Sodium For Injection BP 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 tre atment during clinical trials was 6 weeks, with a range of 1 to 13 weeks, depending on the severity of the infection. Ceftriaxone Sodium for Injection BP Page 7 of 58 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 bili rubin 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 Sodium For Injection BP 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 bili rubin 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,
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 25 Shake well until dissolved. 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.
V. Infusion” listed below. V. 9% Sodium Chloride Injection 5% Dextrose Injection Dextrose and 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.
1 Shake well until dissolved. V. Infusion”. Any unused solution remaining within a period of 8 hours should be discarded. 4 Administration Intramuscular: The reconstituted solution of Ceftriaxone Sodium For Injection BP should be administered by deep intragluteal injection.
It is recommended that not more than 1 g be injected at a single site. Pain on intramuscular injection is usually mild and less frequent when ceftriaxone […]