"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
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.
DOSAGE AND ADMINISTRATION
Use the lowest effective dose 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.
To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Caldolor.
Administer 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be no less than 30 minutes.
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.
Preparation And Administration
Caldolor must be diluted prior to intravenous infusion.
- 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.
Dosage Forms And Strengths
Caldolor is available as a 400 mg/4 mL single-dose vial (100 mg/mL) and 800 mg/8 mL single-dose vial (100 mg/mL).
Storage And Handling
Caldolor is available in the following strengths:
400 mg/4 mL (100 mg/mL)
Carton of 25 vials, NDC 66220-247-04
800 mg/8 mL (100 mg/mL)
Carton of 25 vials, NDC 66220-287-08
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
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: 06/2009This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/29/2014
Additional Caldolor Information
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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