June 28, 2016
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Caldolor

"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...

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Caldolor




Indications
Dosage
How Supplied

INDICATIONS

CALDOLOR is indicated in adults and pediatric patients six months and older for the:

  • management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
  • reduction of fever

DOSAGE AND ADMINISTRATION

Important Dosage And Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

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.

Adults

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.

For Fever

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. Infusion time must be at least 30 minutes. Maximum daily dose is 3,200 mg.

Pediatric Patients

For Analgesia (pain) And Fever

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.

Pediatric Dosing as Necessary for Fever and Pain

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
* Maximum daily dose is 40 mg/kg or 2,400 mg, whichever is less

HOW SUPPLIED

Dosage Forms And Strengths

CALDOLOR (ibuprofen) Injection is a clear, colorless, non-pyrogenic, aqueous solution intended for intravenous use available in an 800 mg/8 mL (100 mg/mL) single-dose vial.

Storage And Handling

CALDOLOR (ibuprofen) Injection is a clear, colorless, non-pyrogenic, aqueous solution intended for intravenous use available in an 800 mg/8 mL (100 mg/mL) single-dose vial.

Carton of 25 vials, NDC 66220-287-08

Storage

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

The stopper in the CALDOLOR vial does not contain natural rubber latex, dry natural rubber, or blends of natural rubber.

Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN 37203. Revised: Apr 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/7/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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