1. Dosage
Nonselective oral and rectal NSAIDs are FDA-approved for use in rheumatoid arthritis/juvenile rheumatoid arthritis (JRA), osteoarthritis, ankylosing spondylitis, pain management, dysmenorrhea, fever, migraines and cluster headaches. JRA is now also known as juvenile idiopathic arthritis (JIA) or juvenile arthritis (JA). Diclofenac, ibuprofen, and naproxen are also available as combination therapy with gastric acid suppressants to minimize the risk of NSAID-associated gastric ulcer development1-39.
1.1. Adults
Adult maximum daily NSAID dosages as monotherapy and combination therapy are summarized in Tables 1 and 2 and should not exceed these recommended maximum values.
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Daily Dosage |
---|---|---|---|
aspirin extended-release (ER) (Durlaza®) | 162.5 mg ER capsule | Reduce risk of death and myocardial infarction (MI) in patients with coronary artery disease (CAD) such as patients with a history of MI, unstable angina pectoris, or chronic stable angina | 162.5 mg once daily |
Reduce risk of death and recurrent stroke in patients with previous ischemic stroke or transient ischemic attack (TIA) | 162.5 mg once daily | ||
aspirin (generics) | 81 mg chewable/EC tablets; 325 mg regular/EC tablets | arterial thromboembolism prophylaxis | 325 mg once daily |
81 mg chewable/enteric-coated (EC) tablets; 325 mg, 500 mg regular/EC tablets; 300 mg, 600 mg rectal suppositories | fever, pain (mild to moderate including dysmenorrhea) | 4000 mg/day in divided doses | |
81 mg chewable/EC tablets; 325 mg regular/EC tablets | myocardial infarction | 325 mg x1 dose, chewed | |
81 mg chewable/EC tablets | myocardial infarction prevention | 162 mg once daily | |
325 mg, 500 mg, regular/EC tablets | osteoarthritis | 3000 mg/day in divided doses | |
325 mg, 500 mg, regular/EC tablets | osteoarthritis | 3000 mg/day in divided doses | |
325 mg, 500 mg, regular/EC tablets | rheumatoid arthritis | titrate to a plasma salicylate level between 150- 300 mcg/ mL | |
81 mg chewable/EC tablets; 325 mg regular/EC tablets | stroke prevention in patients with TIA or other stroke risk factors | 325 mg once daily | |
choline magnesium trisalicylate | 500 mg, 750 mg, 1000 mg tablets; 500 mg/5 mL solution | fever, mild/ moderate pain | 3000 mg/day in divided doses |
osteoarthritis, rheumatoid arthritis, or acute painful shoulder | 3000 mg/ day in divided doses | ||
diclofenac potassium (Cambia®) | 50 mg oral powder for solution | acute migraine attack with or without aura | 50 mg (1 packet) as single dose |
diclofenac potassium immediate-release (IR) (Lofena®, Cataflam®, generics) | 25 mg (Lofena®, generics), 50 mg (Cataflam®, generics) IR tablets | osteoarthritis | 150 mg/day in divided doses |
pain (mild to moderate) | 150 mg/day in divided doses | ||
primary dysmenorrhea | 150 mg/day in divided doses | ||
rheumatoid arthritis | 200 mg/day in divided doses | ||
diclofenac sodium delayed- release (DR) (generics) | 25 mg, 50 mg, 75 mg DR tablets | ankylosing spondylitis | 125 mg/day in divided doses |
osteoarthritis | 150 mg/day in divided doses | ||
rheumatoid arthritis | 200 mg/day in divided doses | ||
diclofenac sodium extended-release (ER) (generics) | 100 mg ER tablets | osteoarthritis | 100 mg once daily |
rheumatoid arthritis | 200 mg/day in divided doses | ||
diclofenac potassium (Zipsor®, generics) | 25 mg capsule | pain (mild to moderate) | 100 mg/day in divided doses |
diclofenac (Zorvolex®, generics) | 18 mg, 35 mg (Zorvolex®, generics) capsules | osteoarthritis | 105 mg/day in divided doses |
pain (mild to moderate) | 105 mg/day in divided doses | ||
diflunisal | 500 mg tablets | osteoarthritis | 1500 mg/day in divided doses |
pain (mild to moderate) | 1500 mg/day in divided doses | ||
rheumatoid arthritis | 1500 mg/day in divided doses | ||
etodolac IR (generics) | 200 mg, 300 mg IR capsule; 400 mg, 500 mg IR tablet | acute pain | 1200 mg/day in divided doses |
osteoarthritis | 1200 mg/day in divided doses | ||
rheumatoid arthritis | 1200 mg/day in divided doses | ||
etodolac ER (generics) | 400 mg, 500 mg, 600 mg ER tablets | osteoarthritis | 1200 mg once daily |
rheumatoid arthritis | 1200 mg once daily | ||
fenoprofen capsules (Nalfon®, generics); tablets (Nalfon®, generics) | 200 mg, 400 mg capsules; 600 mg tablets | osteoarthritis | 3200 mg/day in divided doses |
pain (mild to moderate) | 3200 mg/ day in divided doses | ||
rheumatoid arthritis | 3200 mg/day in divided doses | ||
flurbiprofen (generics) | 50 mg, 100 mg tablets | osteoarthritis | 300 mg/day in divided doses |
rheumatoid arthritis | 300 mg/day in divided doses | ||
ibuprofen (Advil®, Motrin®, generics) | 100 mg chewable tablets; 200 mg, 400 mg, 600 mg, 800 mg tablets; 200 mg capsule; 100 mg/5 mL suspension | dysmenorrhea | 3200 mg/day in divided doses |
fever | 3200 mg/day in divided doses | ||
headache | 3200 mg/day in divided doses | ||
migraine | 3200 mg/day in divided doses | ||
osteoarthritis | 3200 mg/day in divided doses | ||
pain (mild to moderate) | 3200 mg/day in divided doses | ||
rheumatoid arthritis | 3200 mg/day in divided doses | ||
indomethacin IR (generics) | 25 mg, 50 mg capsules; 25 mg/5 mL suspension | acute bursitis or tendinitis | 200 mg/day in divided doses |
acute gouty arthritis | 200 mg/day in divided doses | ||
ankylosing spondylitis | 200 mg/day in divided doses | ||
osteoarthritis | 200 mg/day in divided doses | ||
rheumatoid arthritis | 200 mg/day in divided doses | ||
indomethacin ER (generics) | 75 mg ER capsules | acute bursitis or tendinitis | 150 mg/day in divided doses |
ankylosing spondylitis | 150 mg/day in divided doses | ||
osteoarthritis | 150 mg/day in divided doses | ||
rheumatoid arthritis | 150 mg/day in divided doses | ||
indomethacin (Tivorbex®, generics) | 20 mg capsules | acute pain (mild to moderate) | 120 mg/day in divided doses |
indomethacin rectal (Indocin®) | 50 mg rectal suppository | acute bursitis or tendinitis | 150 mg/day in divided doses; no more than 100 mg per dose |
acute gouty arthritis | 150 mg/day in divided doses; no more than 100 mg per dose | ||
ankylosing spondylitis | 200 mg/day in divided doses; no more than 100 mg per dose | ||
osteoarthritis | 200 mg/day in divided doses; no more than 100 mg per dose | ||
rheumatoid arthritis | 200 mg/day in divided doses; no more than 100 mg per dose | ||
ketoprofen IR (generics) | 25 mg, 50 mg, 75 mg IR capsules | osteoarthritis | 300 mg/day in divided doses |
pain (mild/moderate, including acute dysmenorrhea) | 300 mg/day in divided doses | ||
rheumatoid arthritis | 300 mg/day in divided doses | ||
ketoprofen ER (generics) | 200 mg ER capsule | osteoarthritis | 200 mg once daily |
rheumatoid arthritis | 200 mg once daily | ||
ketorolac (generics) | 10mg tablets | acute pain (moderately severe) following IV or IM treatment | 40 mg/day in divided doses |
magnesium salicylate (Doans®, generics) | 580 mg extended-release caplets | pain (mild/moderate) | 4640 mg/day (8 caplets) in divided doses |
meclofenamate (generics) | 50 mg, 100 mg capsules | acute bursitis or tendinitis | 400 mg/day in divided doses |
acute gouty arthritis | 400 mg/day in divided doses | ||
ankylosing spondylitis | 400 mg/day in divided doses | ||
dysmenorrhea and idiopathic heavy menstrual blood loss | 300 mg/day in divided doses | ||
osteoarthritis | 400 mg/day in divided doses | ||
pain (mild/ moderate) | 400 mg/day in divided doses | ||
rheumatoid arthritis | 400 mg/day in divided doses | ||
mefenamic acid (generics) | 250 mg capsules | pain (mild/ moderate including dysmenorrhea) | 1250 mg in divided doses on day 1; 1000 mg/day in divided doses on days 2-7 |
meloxicam (Mobic®, generics) | 7.5 mg, 15 mg tablets, 7.5 mg/ 5 mL suspension | osteoarthritis | 15 mg/day once daily |
rheumatoid arthritis | 15 mg/day once daily | ||
meloxicam (Vivlodex®, generics) | 5 mg, 10 mg capsules | osteoarthritis | 10 mg/day once daily |
nabumetone (generics) | 500 mg, 750 mg tablets | osteoarthritis | 2000 mg/day in single or divided doses |
rheumatoid arthritis | 2000 mg/day in single or divided doses | ||
naproxen IR (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 | acute gout | 1500 mg/day in divided doses |
ankylosing spondylitis | 1500 mg/day in divided doses | ||
bursitis/tendinitis | 1500 mg/day in divided doses | ||
osteoarthritis | 1500 mg/day in divided doses | ||
pain (mild/moderate including dysmenorrhea) | 1500 mg/day in divided doses | ||
rheumatoid arthritis | 1500 mg/day in divided doses | ||
naproxen sodium (Anaprox DS®, generics) | 220 mg, 275 mg, 550 mg IR tablets | acute gout | 1650 mg/day in divided doses |
ankylosing spondylitis | 1650 mg/day in divided doses | ||
bursitis/tendinitis | 1650 mg/day in divided doses | ||
osteoarthritis | 1650 mg/day in divided doses | ||
pain (mild/moderate including dysmenorrhea) | 1650 mg/day in divided doses | ||
rheumatoid arthritis | 1650 mg/day in divided doses | ||
naproxen DR (EC-Naprosyn®, generics) | 375 mg, 500 mg DR tablets | ankylosing spondylitis | 1500 mg/day in divided doses |
osteoarthritis | 1500 mg/day in divided doses | ||
rheumatoid arthritis | 1500 mg/day in divided doses | ||
naproxen ER (Naprelan®, generics | 375 mg, 500 mg, 750 mg ER tablets | acute gout | 1500 mg/day in divided doses |
ankylosing spondylitis | 1500 mg/day in divided doses | ||
bursitis/tendinitis | 1500 mg/day in divided doses | ||
osteoarthritis | 1500 mg/day in divided doses | ||
pain (mild/moderate including dysmenorrhea) | 1500 mg/day in divided doses | ||
rheumatoid arthritis | 1500 mg/day in divided doses | ||
oxaprozin (Daypro®, generics) | 600 mg tablets | osteoarthritis | 1800 mg/day (not to exceed 26 mg/kg/day) in divided doses |
rheumatoid arthritis | 1800 mg/day (not to exceed 26 mg/kg/day) in divided doses | ||
piroxicam (Feldene®, generics) | 10 mg, 20 mg capsules | osteoarthritis | 20 mg once daily |
rheumatoid arthritis | 20 mg once daily | ||
salsalate (Disalcid®, generics) | 500 mg, 750 mg tablets | osteoarthritis | 3000 mg/day in divided doses |
rheumatoid arthritis | 3000 mg/day in divided doses | ||
sulindac (generics) | 150 mg, 200 mg tablets | acute gouty arthritis | 400 mg/day in divided doses |
ankylosing spondylitis | 400 mg/day in divided doses | ||
bursitis/tendinitis of shoulder | 400 mg/day in divided doses | ||
osteoarthritis | 400 mg/day in divided doses | ||
rheumatoid arthritis | 400 mg/day in divided doses |
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Daily Dosage |
---|---|---|---|
acetaminophen/ aspirin/caffeine (Excedrin® Migraine, generics) | 250 mg/250 mg/65 mg tablets | migraine headache | 2 tablets/24 hours |
pain, including headache | 8 tablets/24 hours in divided doses | ||
acetaminophen/aspirin/caffeine (Goody’s®) | 260 mg/520 mg/32.5 mg powders | pain, including headache | 4 powders/24 hours in divided doses |
aspirin/butalbital/caffeine (Fiorinal®, generics) | 325 mg/50 mg/40 mg capsules, tablets | tension or muscle contraction headache | 6 capsules/24 hours in divided doses (1 or 2 every 4 hours) |
diclofenac/misoprostol (Arthrotec®, generics) | 50 mg/200 mcg, 75 mg/200 mcg delayed-release tablet | osteoarthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers | 150 mg/600 mcg/day in divided doses |
rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers | 200 mg/800 mcg/day in divided doses | ||
ibuprofen/famotidine (Duexis®, generic) | 800 mg/26.6 mg tablet | pain relief in osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers | 2400 mg/79.8 mg/day in divided doses |
pain relief in rheumatoid arthritis and to decrease the risk of developing upper gastrointestinal ulcers | 2400 mg/79.8 mg/day in divided doses | ||
naproxen/esomeprazole (Vimovo®, generic) | 375 mg/20 mg, 500 mg/20 mg delayed-release tablet | ankylosing spondylitis in patients at risk of developing NSAID-associated ulcers | 1000 mg/40 mg/day in divided doses |
osteoarthritis in patients at risk of developing NSAID-associated ulcers | 1000 mg/40 mg/day in divided doses | ||
rheumatoid arthritis in patients at risk of developing NSAID-associated ulcers | 1000 mg/40 mg/day in divided doses |
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.
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 |
|
choline magnesium trisalicylate | 500 mg, 750 mg, 1000 mg tablets; 500 mg/5 mL solution | juvenile rheumatoid arthritis (JRA)/ juvenile idiopathic arthritis (JIA) |
|
diflunisal (generics) | 500 mg tablets | osteoarthritis |
|
pain (mild/moderate) |
|
||
rheumatoid arthritis |
|
||
etodolac extended-release (ER) (generics) | 400 mg, 500 mg, 600 mg ER tablets | JIA/JRA |
|
diflunisal (generics) | 500 mg tablets | osteoarthritis |
|
pain (mild/moderate) |
|
||
rheumatoid arthritis |
|
||
etodolac extended-release (ER) (generics) | 400 mg, 500 mg, 600 mg ER tablets | JIA/JRA |
|
ibuprofen (Motrin®, generics) | 50 mg/1.25 ml oral drops | fever, pain (mild to moderate) |
|
ibuprofen (Advil®, Motrin®, generics) | 100 mg/5 ml suspension | fever, pain (mild to moderate) |
|
ibuprofen (Advil®, generics) | 100 mg chewable tablets | fever, pain (mild to moderate) |
|
ibuprofen (Advil®, generics) | 200 mg caplets, capsules, or tablets | fever, pain (mild to moderate) |
|
ibuprofen (Advil®, Motrin®, generics) | chewable tablets, suspension, tablets | JIA/JRA |
|
indomethacin IR+ (generics) | 25 mg, 50 mg IR capsules; 25 mg/5 mL suspension | arthritic disorders |
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50 mg rectal suppository |
|
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indomethacin ER+ (generics) | 75 mg ER capsules |
|
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magnesium salicylate (Doans®, generics) | 580 mg extended-release caplets | pain (mild to moderate) |
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meclofenamate (generics) | 50 mg, 100 mg capsules | dysmenorrhea |
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JIA/JRA |
|
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pain (mild/moderate) |
|
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mefenamic acid (generics) | 250 mg capsules | pain (mild/moderate, including dysmenorrhea) |
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meloxicam (Mobic®, generics) | 7.5 mg tablets; 7.5 mg orally disintegrating tablets (ODT) | JIA/JRA |
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7.5 mg/5 mL suspension |
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||
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 |
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pain (mild to moderate including dysmenorrhea) |
|
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oxaprozin (Daypro®, generics) | 600 mg tablets | JIA/JRA |
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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
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 |
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