Nonnarcotic analgesics:

Indications for CALDOLOR:

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

Adult:

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.

Children:

<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.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

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.

Pharmacologic Class:

NSAID (propionic acid deriv.).

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.

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.

Generic Availability:

NO

How Supplied:

Single-dose vials (8mL)—25; singe-dose bags (200mL)—20