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.
Risk of serious cardiovascular and gastrointestinal events.
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.
NSAID (propionic acid deriv.).
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.
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.
Single-dose vials (8mL)—25; singe-dose bags (200mL)—20