1.2. Pediatrics

NSAID safety and efficacy in children have not been established for all available agents. Ibuprofen is FDA-approved for short-term management of fever and mild to moderate pain and long-term management of JRA/JIA/JA in pediatric patients; meloxicam and naproxen are FDA-approved for use in children as young as 2 years of age 1,2,24,25,29,37. Indomethacin is not FDA-approved in those less than 15 years of age, but JRA/JIA/JA patients between 2 and 14 years of age who have experienced toxicity/lack of benefit from other medications, may receive indomethacin up to a maximum dose of 3 mg/kg/day (no more than 200 mg/day orally)1,2,17,38. Aspirin, while FDA-approved for use in fever and pain for adolescents, should not be given for fever and muscle aches seen in viral illness due to the potential for Reye’s syndrome1,2,38. Aspirin in combination with acetaminophen and caffeine is FDA-approved for use in adolescent patients for mild to moderate pain, while naproxen/esomeprazole (Vimovo®) is approved for use in adolescents weighing at least 38 kg diagnosed with juvenile idiopathic arthritis at increased risk for NSAID associated gastric ulcers1,2,36 . NSAID dosages for pediatric indications are summarized in Tables 3 and 4. Dosages exceeding these recommendations will be reviewed.

Table 3. NSAID Recommended Maximum Daily Dosages for Pediatric Patients1,2,10,12,16,17,22-24,28-30
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Daily Dosage
aspirin* 81 mg chewable/EC tablets; 325 mg, 500 mg regular/EC tablets; 300 mg, 600 mg rectal suppositories fever/pain
  • Greater than or equal to 12 years of age:
    • 4000 mg/day in divided doses
choline magnesium trisalicylate 500 mg, 750 mg, 1000 mg tablets; 500 mg/5 mL solution juvenile rheumatoid arthritis (JRA)/ juvenile idiopathic arthritis (JIA)
  • Less than 37 kg:
    • 50 mg/kg/day
  • Greater than 37 kg:
    • 2250 mg/day
  • adolescents:
    • 2250 mg/day
diflunisal (generics) 500 mg tablets osteoarthritis
  • Greater than or equal to 12 years of age:
    • 1500 mg/day in divided doses
    pain (mild/moderate)
  • Greater than 12 years of age:
    • 1500 mg/day in divided doses
    rheumatoid arthritis
  • Greater than or equal to 12 years of age:
    • 1500 mg/day in divided doses
etodolac extended-release (ER) (generics) 400 mg, 500 mg, 600 mg ER tablets JIA/JRA
  • Greater than or equal to 6 years of age:
    • 20-30 kg: 400 mg/day
    • 31-45 kg: 600 mg/day
    • 46-60 kg: 800 mg/day
  • Greater than 60 kg:
    • 1000 mg/day
diflunisal (generics) 500 mg tablets osteoarthritis
  • Greater than or equal to 12 years of age:
    • 1500 mg/day in divided doses
    pain (mild/moderate)
  • Greater than 12 years of age:
    • 1500 mg/day in divided doses
    rheumatoid arthritis
  • Greater than or equal to 12 years of age:
    • 1500 mg/day in divided doses
etodolac extended-release (ER) (generics) 400 mg, 500 mg, 600 mg ER tablets JIA/JRA
  • Greater than or equal to 6 years of age:
    • 20-30 kg: 400 mg/day
    • 31-45 kg: 600 mg/day
    • 46-60 kg: 800 mg/day
  • Greater than 60 kg:
    • 1000 mg/day
ibuprofen (Motrin®, generics) 50 mg/1.25 ml oral drops fever, pain (mild to moderate)
  • 6 months to 11 months:
    • 200 mg/day in divided doses
  • 12 to 23 months:
    • 300 mg/day in divided doses
ibuprofen (Advil®, Motrin®, generics) 100 mg/5 ml suspension fever, pain (mild to moderate)
  • 6 months to 2 years:
    • 40 mg/kg/day in divided doses
  • 24-35 lbs (2-3 yrs):
    • 400 mg/day in divided doses
  • 36-47 lbs (4-5 yrs):   
    • 600 mg/day in divided doses
  • 48-59 lbs (6-8 yrs):
    • 800 mg/day in divided doses
  • 60-71 lbs (9-10 yrs):
    • 1000 mg/day in divided doses
  • 72-95 lbs (11 yrs):
    • 1200 mg/day in divided doses
ibuprofen (Advil®, generics) 100 mg chewable tablets fever, pain (mild to moderate)
  • 24-35 lbs (2-3 yrs):
    • 400 mg/day in divided doses
  • 36-47 lbs (4-5 yrs):
    • 600 mg/day in divided doses
  • 48-59 lbs (6-8 yrs):
    • 800 mg/day in divided doses
  • 60-71 lbs (9-10 yrs):
    • 1000 mg/day in divided doses
  • 72-95 lbs (11 yrs):
    • 1200 mg/day in divided doses
ibuprofen (Advil®, generics) 200 mg caplets, capsules, or tablets fever, pain (mild to moderate)
  • 12 years to 17 years:
    • 1200 mg/day in divided doses
ibuprofen (Advil®, Motrin®, generics) chewable tablets, suspension, tablets JIA/JRA
  • 1 to less than 16 years of age:
    • 50 mg/kg/day in divided doses up to 2400 mg/day
indomethacin IR+ (generics) 25 mg, 50 mg IR capsules; 25 mg/5 mL suspension arthritic disorders
  • 15 to 17 years of age:
    • 200 mg/day in divided doses
  50 mg rectal suppository  
  • 15 to 17 years of age:
    • 200 mg/day in divided doses; no more than 100 mg per dose
indomethacin ER+ (generics) 75 mg ER capsules  
  • 15 to 17 years of age:
    • 150 mg/day in divided doses
magnesium salicylate (Doans®, generics) 580 mg extended-release caplets pain (mild to moderate)
  • Greater than or equal to 12 years of age:
    • 4640 mg/day (8 tablets) in divided doses
meclofenamate (generics) 50 mg, 100 mg capsules dysmenorrhea
  • Greater than or equal to 14 years of age:
    • 300 mg/day in divided doses
    JIA/JRA
  • Greater than or equal to 14 years of age:
    • 400 mg/day in divided doses
    pain (mild/moderate)
  • Greater than or equal to 14 years of age:
    • 400 mg/day in divided doses
mefenamic acid (generics) 250 mg capsules pain (mild/moderate, including dysmenorrhea)
  • Greater than or equal to 14 years of age:
    • 1250 mg/day on day 1 (500 mg x1 followed by 250 mg every 6 hours); 1000 mg/day on days 2-7
meloxicam (Mobic®, generics) 7.5 mg tablets; 7.5 mg orally disintegrating tablets (ODT) JIA/JRA
  • 2-17 years of age, Greater than or equal to 60 kg:
    • 7.5 mg once daily
  7.5 mg/5 mL suspension  
  • Greater than or equal to 2 years of age: 
    • 0.125 mg/ kg once daily
    • 12 kg: 1.5 mg once daily
    • 24 kg: 3.0 mg once daily
    • 36 kg: 4.5 mg once daily
    • 48 kg: 6.0 mg once daily
  • Greater than or equal to 60 kg:
    • 7.5 mg once daily
naproxen (Aleve®, Naprosyn®, generics) 220 mg IR capsule; 220 mg, 250 mg, 275 mg, 375 mg, 500 mg IR tablets; 125 mg/5 mL IR suspension JIA/JRA
  • Greater than or equal to 2 years of age:
    • 15 mg/kg/day in divided doses up to 1000 mg/ day
    pain (mild to moderate including dysmenorrhea)
  • Greater than 12 years of age:
    • 1000 mg/day in divided doses
oxaprozin (Daypro®, generics) 600 mg tablets JIA/JRA
  • Greater than 6 years to 16 years of age:
    • 22-31 kg: 600 mg/day
    • 32-54 kg: 900 mg/day
  • Greater than 55 kg:
    • 1200 mg/day

Legend:

  • *Do not use in children less than 12 years of age with flu-like symptoms or chickenpox due to risk of Reye syndrome
  • +indomethacin not recommended in pediatric patients 2-14 years of age unless adverse effects/lack of efficacy with other NSAIDs justifies risk; maximum dose is 4 mg/kg/day or 200 mg/day, whichever is less
Table 4. NSAID Maximum Recommended Daily Dosages for Pediatrics: Non-Opioid Combination Therapy1,2,36
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Daily Dosage 
acetaminophen/aspirin/caffeine (Excedrin®, generics) 250 mg/250 mg/65 mg tablets pain, including headache 12-17 years of age: 8 tablets/24 hours in divided doses
acetaminophen/aspirin/caffeine (Goody’s®) 260 mg/ 520 mg/ 32.5 mg powders   12-17 years of age: 4 powders/24 hours in divided doses
naproxen/esomeprazole (Vimovo®, generic) 375 mg/20 mg, 500 mg/20 mg delayed-release tablet juvenile rheumatoid arthritis/ juvenile idiopathic arthritis in patients at risk of developing NSAID-associated ulcers
  • 12-17 years of age and Greater than or equal to 50 kg:
    • 1000 mg/40 mg/day in two divided doses
  • 12-17 years of age and 38 to 49 kg:
    • 750 mg/40 mg/day in two divided doses