Caldolor
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Caldolor is indicated in adults for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics.
Caldolor is indicated for the reduction of fever in adults.
History
There is currently no drug history available for this drug.
Other Information
Caldolor contains the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C. It has a molecular weight of 206.28. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is represented below:
Each 1 mL of solution contains 100 mg of ibuprofen in Water for Injection, USP. The product also contains 78 mg/mL arginine at a molar ratio of 0.92:1 arginine:ibuprofen. The solution pH is about 7.4.
Caldolor is sterile and is intended for intravenous administration only.
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Sources
Caldolor Manufacturers
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Cumberland Pharmaceuticals Inc.
![Caldolor (Ibuprofen) Injection [Cumberland Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Caldolor | Cumberland Pharmaceuticals Inc.
Use the lowest effective dose 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.
To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Caldolor.
2.1 Analgesia (Pain)Administer 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be no less than 30 minutes.
2.2 Antipyretic (Fever)Administer 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. Infusion time must be no less than 30 minutes.
2.3 Preparation and AdministrationCaldolor must be diluted prior to intravenous infusion. 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.
800 mg dose: Dilute 8 mL of Caldolor in no less than 200 mL of diluent. 400 mg dose: Dilute 4 mL of Caldolor in no less than 100 mL of diluent.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 to 25° C) and room lighting.
Infusion time must be no less than 30 minutes.
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