Generic Name and Formulations:
Ibuprofen 100mg/mL; for IV infusion after dilution.
Cumberland Pharmaceuticals, Inc.
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.
NSAID (propionic acid deriv.).
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.
Nausea, flatulence, vomiting, headache, hemorrhage, dizziness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, peripheral edema, anemia/blood dyscrasias, hypertension.
Single-dose vials (8mL)—25
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