Generic name: ibuprofen 400mg in 4mL
Dosage form: intravenous injection
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Important Dosage and Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
After observing the response to initial therapy with CALDOLOR, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose in adults. Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients less than 17 years of age.
To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of CALDOLOR.
CALDOLOR must be diluted prior to administration.
Dilute to a final concentration of 4 mg/mL or less. Appropriate diluents include 0.9% Sodium Chloride Injection USP (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution.
- 100 mg dose: Dilute 1 mL of CALDOLOR in at least 100 mL of diluent
- 200 mg dose: Dilute 2 mL of CALDOLOR in at least 100 mL of diluent
- 400 mg dose: Dilute 4 mL of CALDOLOR in at least 100 mL of diluent
- 800 mg dose: Dilute 8 mL of CALDOLOR in at least 200 mL of diluent
For weight-based dosing at 10 mg/kg ensure that the concentration of CALDOLOR is 4 mg/mL or less.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.
Diluted solutions are stable for up to 24 hours at ambient temperature (approximately 20° C to 25° C) and room lighting.
For Analgesia (pain):
The dose is 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be at least 30 minutes. Maximum daily dose is 3,200 mg.
2.3 Pediatric Patients
Ages 12 to 17 years of age
The dose is 400 mg intravenously every 4 to 6 hours as necessary. Infusion time must be at least 10 minutes. Maximum daily dose is 2,400 mg.
Ages 6 months to 12 years of age
The dose is 10 mg/kg intravenously up to a maximum single dose of 400 mg every 4 to 6 hours as necessary. Infusion time must be at least 10 minutes. Maximum daily dose is 40 mg/kg or 2,400 mg, whichever is less.
* Maximum daily dose is 40 mg/kg or 2,400 mg, whichever is less
|Age Group||Dose||Dosing Interval||Min infusion time||Max daily dose|
|6 months to less than 12 years||10 mg/kg up to 400 mg max||Every 4 to 6 hours as necessary||10 minutes||*40 mg/Kg or 2,400 mg|
|12 to 17 years||400 mg||Every 4 to 6 hours as necessary||10 minutes||2,400 mg|