Names and pronunciation
Caldolor, NeoProfen
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Drug reference
Caldolor, NeoProfen
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Func. class.: NSAID
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Chem. class.: Propionic acid derivative
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Do not confuse: Motrin/neurontin ibuprofen/acetaminophen
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ACTION: Inhibits COX-1, COX-2 by blocking arachidonate; analgesic, antiin- flammatory, antipyretic
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USES: Inflammatory disorders: Rheu- matoid arthritis, osteoarthritis, primary dysmenorrhea, dental pain, musculoskeletal disorders, fever, migraine, patent ductus arteriosus, headache
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Unlabeled uses: Ankylosing spondylitis, bone pain, cystic fibrosis, gouty arthritis, psoriatic arthritis
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CONTRAINDICATIONS: Preg- nancy 3rd trimester; hypersensitivity to this product, NSAIDs, salicylates; asthma; severe renal/hepatic disease; periopera- tive pain in CABG, severe HF, active GI ulcer, IBD, risk of bleeding Precautions: Pregnancy 1st and 2nd tri- mesters, breastfeeding, children, geriatric patients, bleeding disorders, GI disorders, renal disorders, cardiac disorders, hyper- sensitivity to other antiinflammatory agents, HF, CCr <25 mL/min
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Black Box Warning: GI bleeding, MI, stroke Black Box Warning: GI Bleeding: As- sess for bleeding, bruising, ulceration, perforation of stomach • Nephrotoxicity: to report change in uri nary pattern, increased weight, edema, in creased pain in joints, fever, blood in urine • To avoid alcohol, NSAIDs, salicylates; bleeding may occur • To report use of this product to all health care providers • Pregnancy: to notify prescriber if pregnancy is planned or suspected; avoid after 30 wk • To avoid driving or other hazardous activities until effect is known Black Box Warning: MI/stroke: to report signs/symptoms of MI/stroke immediate- ly; discontinue product, seek emergency medical treatment • To take with full glass of water; to sit upright for 30 min after use; to take with food to lessen GI effects
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SIDE EFFECTS CNS: Headache, dizziness, drowsiness, fatigue CV: Tachycardia, peripheral edema, pal- pitations, dysrhythmias, CV thrombotic events, MI, stroke, HF EENT: Tinnitus, hearing loss, blurred vision GI: Nausea, anorexia, vomiting, diar- rhea, jaundice, constipation, flatulence, cramps, dry mouth, peptic ulcer, GI bleeding, ulceration, necrotizing entero colitis, GI perforation GU: Nephrotoxicity, dysuria, hematuria, oliguria, azotemia HEMA: Blood dyscrasias, increased bleeding time INTEG: Purpura, rash, pruritus, urti- caria, necrotizing fasciitis, photosensitiv- ity, photophobia ENDO: Hyperkalemia, hyperuricemia, hypoglycemia, hyponatremia SYST: Anaphylaxis, Stevens-Johnson syndrome
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INTERACTIONS Increase: renal dysfunction risk—ACEI/ ARBs Increase: bleeding risk—valproic acid, thrombolytics, antiplatelets, anticoagu- lants, salicylates, SSRIs Increase: blood dyscrasia risk—antineo- plastics, radiation Increase: toxicity—lithium, oral antico agulants, cycloSPORINE, methotrexate Increase: GI reactions—aspirin, cortico- steroids, NSAIDs, alcohol, tobacco Increase: hypoglycemia—oral antidiabetics Decrease: effect of antihypertensives, thiazides, furosemide Decrease: ibuprofen action—aspirin Drug/Herb Increase: bleeding risk—feverfew, fish oil garlic, ginger, ginkgo, ginseng (Panax), horse chestnut, red clover Drug/Lab Test Increase: BUN, creatinine, LFTs, potassium Decrease: HB/Hct, blood glucose, WBC, platelets I
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TREATMENT OF OVERDOSE: Lavage if recently ingested, induce diuresis
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DOSAGE AND ROUTES Self-treatment of minor aches/ pains • Adult/adolescent: PO (OTC product) 200 mg q4-6hr, may increase to 400 mg q4-6hr if needed, max 1200 mg/day • Child 11 yr (72-95 lb): PO 300 mg q6-8hr • Child 9-10 yr (60-71 lb): PO 250 mg q6-8hr • Child 6-8 yr (48-59 lb): PO 200 mg q6-8hr • Child 4-5 yr (36-47 lb): PO 150 mg q6-8hr • Child 2-3 yr (24-35 lb): PO 100 mg q6-8hr • Child 12-23 mo (18-23 lb): PO 75 mg q6-8hr • Child 6-11 mo (12-17 lb): PO 50 mg q6-8hr Analgesic • Adult: PO 200-400 mg q4-6hr, max 3.2 g/day; OTC use max 1200 mg/day • Child: PO 4-10 mg/kg/dose q6-8hr Moderate to severe pain (hospitalized patients) (Caldolor) • Adult: IV 400-800 mg q6hr as an ad- junct to opiate-agonist therapy Dysmenorrhea • Adult: PO 400 mg q4-6hr, max 1200 mg/day Antipyretic • Child 6 mo-12 yr: PO 5 mg/kg (tem- perature <102.5°F or 39.2°C), 10 mg/kg (temperature >102.5°F), may repeat q6- 8hr, max 40 mg/kg/day or 2400 mg/day whichever is less Antiinflammatory • Adult: PO 400-800 mg tid-qid, max 3.2 g/day • Child: PO 30-40 mg/kg/day in 3-4 di- vided doses, max 50 mg/kg/day or 2400 mg/day whichever is less Juvenile arthritis • Child: PO 30-50mg/kg/day divided in 3-4 doses, max 2.4 g per day Patent ductus arteriosus (PDA) (NeoProfen) • Premature neonate #32 wk gestation who weighs 500-1500 g: IV 10 mg/kg ini- tially, then, if needed, 2 doses of 5 mg/kg at 24-hr intervals; if oliguria occurs, hold dose Cystic fibrosis (unlabeled) • Child 6 mo-12 yr: PO 20-30mg/kg/ dose twice daily, max 1600 mg per dose
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Available forms: Caps 200 mg; tabs 100, 200, 300 , 400, 600, 800 mg; cap, liq gels 200 mg; oral susp 40 mg/ mL, 100 mg/5 mL; liq 100 mg/5 mL; chew tabs 100 mg; oral drops 50 mg/1.25 mL; inj 10 mg/mL (NeoProfen)
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Administer: PO route • With food, milk, or antacid to decrease GI symptoms; if nausea and vomiting oc- cur or persist, notify prescriber • Shake suspension well before use • Do not break, crush, chew enteric- or film-coated products • Do not use in pregnancy after 30 wk gestation • Store at room temperature IV route • Patient must be well hydrated before administration • Dilute to ≤4 mg/mL with 0.9% NaCl, LR, D5W; infuse over ≥30 min; do not give IM • Discard unused portion • Visually inspect for particulate prior to use • Ibuprofen lysine: dilute with dextrose or saline to appropriate volume (10 mg/mL of ibuprofen is recommended); give within 30 min of preparation; give via IV port nearest insertion site; give over 15 min • Check for extravasation; do not give in same line with TPN; interrupt TPN for 15 min before and after product administration
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Assess: Black Box Warning: GI bleeding/ perforation: chronic use can cause gastritis with or without bleeding; for those with a pri- or history of peptic ulcer disease or GI bleed- ing, initiate treatment at lower dose; geriatric patients are at greater risk and those who consume >3 alcoholic drinks/day • Renal, hepatic, blood studies: BUN, creatinine, AST, ALT, HB, stool guaiac, before treatment, periodically thereafter; monitor electrolytes as needed; make sure patient is well hydrated • Perioperative pain in CABG: MI and stroke can result for 10-14 days; can be fatal; those taking NSAIDs are at greater risk of MI and stroke even in first few weeks of therapy • Cardiac status: edema (peripheral), tachycardia, palpitations; monitor B/P, pulse for character, quality, rhythm, espe- cially in patients with cardiac disease, geri- atric patients • Pain: note type, duration, location, intensity with ROM 1 hr after administra- tion • PDA closure: monitor for bleeding, oliguria, infection; in preterm neonates use only doses needed for ductus arterio- sus closure, hold dose if renal output <0.6 mL/kg/hr on 2nd/3rd dose • Dysmenorrhea: give at onset of menses • Audiometric, ophthalmic exam before, during, after long-term treatment; for eye, ear problems: blurred vision, tinni- tus; may indicate toxicity • Infection: may mask symptoms; fever: temperature before and 1 hr after admin- istration • For history of peptic ulcer disorder, asthma, aspirin use, hypersensitivity; check closely for hypersensitivity reactions • Serious skin disorders: for skin rash or swelling of lips, face, tongue; if pres ent, discontinue immediately, provide supportive care • Beers: avoid chronic use in older adults unless other alternatives are inef- fective; increased risk of GI bleeding • Pregnancy: identify if pregnancy is planned or suspected, or if breastfeeding; do not use after 30 wk gestation; use only if benefits outweigh fetal risk before 30 wk gestation; do not breastfeed
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Evaluate: • Therapeutic response: decreased pain, stiffness in joints; decreased swelling in joints; ability to move more easily; reduc- tion in fever or menstrual cramping
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To use sunscreen, sunglasses, and pro- tective clothing to prevent photosensitiv- ity, photophobia • To report blurred vision, ringing, roar- ing in ears (may indicate toxicity); that eye and hearing tests should be done during long-term therapy • To avoid driving, other hazardous ac- tivities if dizziness or drowsiness occurs
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PHARMACOKINETICS PO: Onset ½ hr, peak 1-2 hr, duration 4-6 hr; IV: duration 4-6 hr, half-life 1.8-2 hr (adult), 1-2 hr (child) metabolized in liver (inactive metabolites), excreted in urine (inactive metabolites), 90%-99% protein binding, does not enter breast milk, well absorbed
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• Child 11 yr (72-95 lb): PO 300 mg q6-8hr
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• Child 9-10 yr (60-71 lb): PO 250 mg q6-8hr
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• Child 6-8 yr (48-59 lb): PO 200 mg q6-8hr
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• Child 4-5 yr (36-47 lb): PO 150 mg q6-8hr
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• Child 2-3 yr (24-35 lb): PO 100 mg q6-8hr
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• Child 12-23 mo (18-23 lb): PO 75 mg q6-8hr
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• Child 6-11 mo (12-17 lb): PO 50 mg q6-8hr Analgesic
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• Child: PO 4-10 mg/kg/dose q6-8hr Moderate to severe pain (hospitalized patients) (Caldolor)
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• Child 6 mo-12 yr: PO 5 mg/kg (tem- perature <102.5°F or 39.2°C), 10 mg/kg (temperature >102.5°F), may repeat q6- 8hr, max 40 mg/kg/day or 2400 mg/day whichever is less Antiinflammatory
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• Child: PO 30-40 mg/kg/day in 3-4 di- vided doses, max 50 mg/kg/day or 2400 mg/day whichever is less Juvenile arthritis
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• Child: PO 30-50mg/kg/day divided in 3-4 doses, max 2.4 g per day Patent ductus arteriosus (PDA) (NeoProfen)
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• Child 6 mo-12 yr: PO 20-30mg/kg/ dose twice daily, max 1600 mg per dose
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