| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Caldolor safely and effectively. See full prescribing information for Caldolor.
CALDOLOR (ibuprofen) Injection, for intravenous use
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.
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.
| CLINICAL PHARMACOLOGY
Mechanism of Action
| INDICATIONS AND USAGE
— Known hypersensitivity to ibuprofen or other NSAIDs
| WARNINGS AND PRECAUTIONS
–Serious and potentially fatal CV thrombotic events: Use lowest effective dose of Caldolor for shortest possible duration.
–Serious and potentially fatal GI reactions: Use lowest effective dose of Caldolor for shortest possible duration. Use with caution in patients with prior history of ulcer disease or GI bleeding.
–Hepatic effects: Range from transaminase elevations to liver failure. Discontinue Caldolor immediately if abnormal liver tests persist or worsen.
–Hypertension: Can occur with NSAID treatment. Monitor blood pressure closely during treatment with Caldolor.
–Congestive heart failure and edema: Fluid retention and edema can occur with NSAID treatment. Use Caldolor with caution in patients with fluid retention or heart failure.
–Renal effects: Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use Caldolor with caution in patients at risk (e.g., the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors).
— Anaphylactoid reactions: May occur in patients with the aspirin triad or in patients without prior exposure to Caldolor. Discontinue Caldolor immediately if an anaphylactoid reaction occurs.
–Serious skin reactions: Include exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue Caldolor if rash or other signs of local skin reaction occur.
| ADVERSE REACTIONS
The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
| DOSAGE AND ADMINISTRATION
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.
Preparation and Administration
— 800 mg dose: Dilute 8 mL of Caldolor in no less than 200 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.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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