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 thanup 6 months to 17 years of age.

The dosage is limited to a single dose not to exceed 10 mg/kg or 100 mg, whichever is less, in pediatric patients 3 months to less than 6 months of age.

To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of CALDOLOR.

CALDOLOR injection 800 mg/8 mL (100 mg/mL) vials 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

CALDOLOR injection 800 mg/200 mL (4 mg/mL) polypropylene flexible bags are ready to use, intended for 800 mg doses only.

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.

Adults

Pediatric Patients