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
Initial U.S. Approval: 1974
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning
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Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (5.1)
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CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
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NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. (5.2)
RECENT MAJOR CHANGES
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Boxed Warning |
11/2015 |
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Indications and Usage (1) |
11/2015 |
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Dosage and Administration (2.1, 2.2, 2.3) |
11/2015 |
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Warnings and Precautions, Cardiovascular Thrombotic Events (5.1) |
11/2015 |
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Warnings and Precautions, Heart Failure and Edema (5.5) |
11/2015 |
INDICATIONS AND USAGE
CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients six months and older for the:
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Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics (1)
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Reduction of fever (1)
DOSAGE AND ADMINISTRATION
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Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals
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Adult Pain: 400 mg to 800 mg intravenously over 30 minutes every 6 hours as necessary. (2.2)
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Adult 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)
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Pediatric (pain and fever) ages 12 to 17 years of age: 400 mg intravenously over 10 minutes every 4 to 6 hours as necessary (2.3)
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Pediatric (pain and fever) ages 6 months to 12 years of age: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 400 mg every 4 to 6 hours as necessary (2.3)
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CALDOLOR must be diluted before administration. (2.1)
DOSAGE FORMS AND STRENGTHS
CALDOLOR (ibuprofen) Injection: 800 mg/8 mL (3)
CONTRAINDICATIONS
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Known hypersensitivity to ibuprofen or any component of the drug product (4)
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History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs (4)
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In the setting of CABG surgery (4)
WARNINGS AND PRECAUTIONS
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Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
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Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
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Heart Failure and Edema: Avoid use of CALDOLOR in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
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Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CALDOLOR in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
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Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
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Exacerbation of Asthma Related to Aspirin Sensitivity: CALDOLOR is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
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Serious Skin Reactions: Discontinue CALDOLOR at first appearance of skin rash or other signs of hypersensitivity (5.9)
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Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation (5.10, 8.1)
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Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.11, 7)
The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%).
The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (≥2%). (6)
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.
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Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking CALDOLOR with drugs that interfere with hemostasis. Concomitant use of CALDOLOR and analgesic doses of aspirin is not generally recommended (7)
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ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with CALDOLOR may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)
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ACE Inhibitors and ARBs: Concomitant use with CALDOLOR in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7)
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Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)
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Digoxin: Concomitant use with CALDOLOR can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7)
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation (5.10, 8.1)
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of CALDOLOR in women who have difficulties conceiving |
