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Drug Name:


Generic Name and Formulations:
Ibuprofen 100mg/mL; for IV infusion after dilution.

Cumberland Pharmaceuticals, Inc.

Therapeutic Use:

Indications for CALDOLOR:

Mild-to-moderate pain. Moderate-to-severe pain adjunct to opioids. Fever.


Use lowest effective dose for shortest duration. ≥18yrs: Give by IV infusion over 30 mins. Maintain adequate hydration. Pain: 400mg–800mg every 6 hours as needed. Fever: initially 400mg, followed by 400mg every 4–6 hours or 100–200mg every 4 hours as needed. Max: 3200mg/day.


<6mos: not established. Use lowest effective dose for shortest duration. Give by IV infusion over 10 mins. Maintain adequate hydration. Pain and fever (≥6mos–<12yrs): 10mg/kg up to max single dose of 400mg every 4–6 hours as needed; max: 40mg/kg or 2400mg per day, whichever is less; (12–17yrs): 400mg every 4–6 hours as needed; max: 2400mg/day.


Aspirin allergy. Coronary artery bypass graft surgery.


Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; 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. Advanced renal disease: not recommended. 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. Pregnancy (3rd trimester; avoid). Nursing mothers.


Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. 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 (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Pharmacological Class:

NSAID (propionic acid deriv.).

Adverse Reactions:

Nausea, flatulence, vomiting, headache, hemorrhage, dizziness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, peripheral edema, anemia/blood dyscrasias, hypertension.

Generic Availability:


How Supplied:

Single-dose vials (8mL)—25

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