Data from FDA - Curated by EPG Health - Last updated 21 December 2016
4 CONTRAINDICATIONS 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 and Dextrose Injection 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)].
To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
The following reactions occurred in less than or equal to 6 % of the patients: Local reactions-pain, induration,
Hypersensitivity-rash, pruritus, fever or chills.
Hematologic-eosinophilia, thrombocytosis, leucopenia, anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia, and prolongation of the prothrombin time.
The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3)].
Hepatic-elevations of SGOT, SGPT, alkaline phosphatase, bilirubin.
Renal-elevations of the BUN, creatinine, and the presence of casts in the
Genitourinary-moniliasis or vaginitis.
Miscellaneous-diaphoresis and flushing.
Ceftriaxone-calcium precipitates-Cases of
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)].
6.2 Postmarketing Experience The following
Because these reactions are reported voluntarily from
Gastrointestinal-stomatitis and glossitis.
Immunologic - Anaphylaxis (anaphylactic
Altered Laboratory Tests:
2 DOSAGE AND ADMINISTRATION For intravenous use only over approximately 30
(2) Use this formulation of ceftriaxone only in
Surgical Prophylaxis 1 gram IV once 1/2 to 2 hours before surgery Meningitis 100 mg/kg once a day or in equally divided doses
Population Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container should be used only in
Ceftriaxone for Injection and Dextrose Injection should be administered intravenously (IV) over approximately 30
The usual duration of therapy is 4 to 14 days; in
Surgical Prophylaxis 1 gram IV once 1/2 to 2 hours before surgery Skin and Skin Structure
[see Use in Specific Populations (8.4)] 2.3 Preparation for Use of Ceftriaxone for Injection and Dextrose Injection in DUPLEX® Container This reconstituted solution is for intravenous use only.
Such use would result in air embolism due to residual air being drawn from the primary container before
If administration is controlled by a pumping device,
Parenteral drug products should be inspected visually for particulate matter and
Use only if
DUPLEX® Drug Delivery System Storage To avoid
Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.
Do not cover any portion of foil strip with patient label.
Unlatch side tab and unfold DUPLEX® Container (see Diagram 1).
Visually inspect diluent chamber for particulate matter.
Use only if
To inspect the drug powder for foreign matter or
If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate.
The product must then be used within 7 days, but not beyond the labeled expiration date.
Diagram 1 Diagram 2 Reconstitution (Activation) Do not
Unfold the DUPLEX® container and point the set port in a
Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold.
To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3).
Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.
Diagram 3 Administration Visually inspect the reconstituted solution for particulate matter.
Point the set port in a downwards direction.
Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold.
Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4).
Prior to attaching the IV set, check for minute leaks by squeezing
If leaks are found,
Using aseptic technique, peel foil cover from the set port and attach
Refer to directions for use accompanying the administration set.
Do not introduce additives into the DUPLEX®
Administer Ceftriaxone for Injection and Dextrose Injection intravenously over approximately 30
After the indicated stability time periods,
Vancomycin, amsacrine, aminoglycosides, and
When any of these drugs are to be administered concomitantly with ceftriaxone by
Ceftriaxone for Injection and Dextrose Injection should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs due to possible
[see Drug Interactions (7.1)] Precipitation of ceftriaxone-calcium can also occur when Ceftriaxone for Injection and Dextrose Injection is mixed with calcium-containing solutions in the same IV administration line.
Ceftriaxone for Injection and Dextrose Injection 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 for Injection and Dextrose Injection and calcium-containing solutions may be administered sequentially of one another if
[see Warnings and Precautions (5.2)] There have been
8 USE IN SPECIFIC POPULATIONS Hepatic and renal
(2.2, 8.4) 8.1 Pregnancy Pregnancy Category B Reproductive studies have been performed in mice,
These doses are approximately 1.5, 2.8, and 0.8 times the
There are, however,
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
8.3 Nursing Mothers Ceftriaxone is excreted in human breast milk.
8.4 Pediatric Use Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftriaxone.
8.5 Geriatric Use Of the total number of subjects in clinical studies of ceftriaxone sodium, 32 % were 60 and over.
Because elderly patients are more likely to have
The pharmacokinetics of ceftriaxone were only minimally altered in geriatric patients compared to
[see Clinical Pharmacology (12)]
|Date Last Revised||21-07-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||B. Braun Medical Inc.|