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Caldolor Generic Name & Formulations
Legal Class
Rx
General Description
Ibuprofen 100mg/mL; per vial; for IV infusion after dilution; or 4mg/mL; per bag; for IV infusion.
Pharmacological Class
NSAID (propionic acid deriv.).
How Supplied
Single-dose vials (8mL)—25; Single-dose (ready-to-use) bags (200mL)—20
Manufacturer
Generic Availability
NO
Mechanism of Action
The mechanism of action of Caldolor, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Caldolor Indications
Indications
Mild to moderate pain. Moderate to severe pain adjunct to opioids. Fever.
Caldolor Dosage and Administration
Adult
Use lowest effective dose for shortest duration. ≥18yrs: Give by IV infusion over 30mins. Maintain adequate hydration. Pain: 400mg–800mg every 6hrs as needed. Fever: initially 400mg, followed by 400mg every 4–6hrs or 100–200mg every 4hrs as needed. Max: 3200mg/day.
Children
<3mos: not established. Use lowest effective dose for shortest duration. Give by IV infusion over 10mins. Maintain adequate hydration. Pain and fever (≥3mos–<6mos): 10mg/kg up to max single dose of 100mg;(≥6mos–<12yrs): 10mg/kg up to max single dose of 400mg every 4–6hrs as needed; max: 40mg/kg or 2400mg per day, whichever is less; (12–17yrs): 400mg every 4–6hrs as needed; max: 2400mg/day.
Caldolor Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Caldolor Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Caldolor Warnings/Precautions
Warnings/Precautions
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (3rd trimester; avoid). Nursing mothers.
Caldolor Pharmacokinetics
Elimination
Half-life: 2.22 hours (400mg); 2.44 hours (800mg); 1.5–1.8 hours (10mg/kg).
Caldolor Interactions
Interactions
Concomitant aspirin, salicylates (eg, diflunisal, salsalate), other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. May potentiate digoxin, lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.
Caldolor Adverse Reactions
Adverse Reactions
Nausea, flatulence, vomiting, headache, hemorrhage, dizziness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), peripheral edema, anemia/blood dyscrasias, hypertension, aseptic meningitis.
Caldolor Clinical Trials
See Literature
Caldolor Note
Not Applicable
Caldolor Patient Counseling
See Literature
