CALDOLOR 800 mg/8 mL vials (100 mg/mL) must be diluted prior to intravenous infusion.
Use without dilution can cause hemolysis. The CALDOLOR vials should not be given as an IV bolus or IM injection. 1
Dilute to a final concentration of 4 mg/mL or less.1
For weight-based dosing at 10 mg/kg, ensure that the concentration of CALDOLOR is 4 mg/mL or less. Diluted solutions are stable for up to 24 hours at ambient temperature (approximately 20° to 25° C) and room lighting.
CALDOLOR is available in 800 mg/8 mL single-dose vials (100 mg/mL) with a 20 mm closure. The stopper in the CALDOLOR vial is not made with natural rubber latex.
To prepare an 800 mg dose using a needleless transfer system with the CALDOLOR vial, CALDOLOR is compatible with the Vial2Bag® IV drug transfer system.
CALDOLOR in a ready-to-use bag
CALDOLOR 800 mg/200 mL (4 mg/mL) bags are ready-to-use and require no dilution prior to use.
Diluent is an iso-osmotic phosphate buffer with an approximate pH of 7.4
|For Analgesia (pain):||For Fever:|
|The dose is 400 to 800 mg intravenously every 6 hours as necessary. Maximum daily dose is 3,200 mg.||The dose is 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100 mg to 200 mg every 4 hours as necessary. Maximum daily dose is 3,200 mg.|
|In key clinical trials, CALDOLOR was infused over 30 minutes. In Phase IV studies, CALDOLOR was found to be well tolerated when administered over a period of 5 to 10 minutes. CALDOLOR therapy has been initiated pre-, intra- and postoperatively in analgesic studies.|
For Analgesia (pain) and Fever:
|Age Group||Dose||Dosing Interval||Min Infusion Time||Max Daily Dose|
|3 months to less than 6 months||10 mg/kg up to 100 mg||Single Dose||10 minutes||100 mg|
|6 months to less than 12 years||10 mg/kg up to 400 mg||Every 4 to 6 hours as necessary||10 minutes||40 mg/kg or 2,400 mg, whichever is less|
|12 to 17 years||400 mg||Every 4 to 6 hours as necessary||10 minutes||2,400 mg|
|Pediatric patients received a single dose of 10 mg/kg (up to 600 mg) CALDOLOR at induction of anesthesia in a multicenter, randomized, double-blind study for treatment of pain associated with surgical tonsillectomy.|