INDICATIONS AND USAGE

Caldolor is an NSAID indicated in adults for the:

• Management of mild to moderate pain (1.1)
• Management of moderate to severe pain as an adjunct to opioid analgesics (1.1)
• Reduction of fever (1.2)

DOSAGE AND ADMINISTRATION

• Pain: 400 mg to 800 mg intravenously over 30 minutes every 6 hours as necessary. (2.1)
• Fever: 400 mg intravenously over 30 minutes, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. (2.2)
• Patients must be well hydrated before Caldolor administration.
• Caldolor must be diluted before administration. (2.3)

DOSAGE FORMS AND STRENGTHS

Vials: 400 mg/4 mL or 800 mg/8 mL (3)

CONTRAINDICATIONS

• Known hypersensitivity to ibuprofen or other NSAIDs (4.1)
• Asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs (4.2)
• Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery (4.3, 5.1)

WARNINGS AND PRECAUTIONS

• Serious and potentially fatal CV thrombotic events: Use lowest effective dose of Caldolor for shortest possible duration. (5.1)
• 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. (5.2)
• Hepatic effects: Range from transaminase elevations to liver failure. Discontinue Caldolor immediately if abnormal liver tests persist or worsen. (5.3, 5.15)
• Hypertension: Can occur with NSAID treatment. Monitor blood pressure closely during treatment with Caldolor. (5.4)
• 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. (5.5)
• 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). (5.6)
• 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. (5.7, 5.12)
• 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. (5.8)

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.

DRUG INTERACTIONS

• ACE inhibitors: NSAIDs may diminish the antihypertensive effect of ACE inhibitors. (7.3)
• Aspirin: Concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects. (7.1)

USE IN SPECIFIC POPULATIONS

• Pregnancy: Avoid use after 30 weeks gestation because premature closure of the ductus arteriosus in the fetus may occur. (8.1)
• Nursing Mothers: Use with caution as it is not known if ibuprofen is excreted in human milk. (8.3)
• Pediatric Use: Safety and effectiveness not established in patients less than 17 years of age. (8.4)