Naproxen Indications and Dosage
ankylosing spondylitis
arthralgia
bone pain †
bursitis
dental pain
dysmenorrhea
fever
gouty arthritis
headache
heterotopic ossification †
juvenile rheumatoid arthritis (JRA)
migraine †
migraine prophylaxis †
mild pain
moderate pain
myalgia
osteoarthritis
rheumatoid arthritis
tendinitis
† non-FDA-approved indication
Naproxen Indications and Dosage
For the treatment of mild to moderately severe musculoskeletal inflammation including osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis:
NOTE: Individualize dosage to achieve the lowest effective dose and minimize adverse events. Dividing the daily dose into 3 doses versus 2 doses generally does not affect response.
Oral dosage (naproxen tablets or oral suspension, Naprosyn®):
Adults: 250 - 500 mg PO twice daily. Morning and evening doses do not have to be equal in size. The dose may be increased to 1500 mg/day for limited periods when a higher level of analgesic/anti-inflammatory activity is required.
Oral dosage (naproxen sodium tablets, Anaprox®, Anaprox DS®):
Adults: 275 - 550 mg PO twice daily. Morning and evening doses do not have to be equal in size. The dose may be increased to 1650 mg/day for limited periods when a higher level of analgesic/anti-inflammatory activity is required.
Oral dosage (naproxen delayed-release tablets, EC Naprosyn®):
Adults: 375 - 500 mg PO twice daily.
Oral dosage (naproxen sodium, once-daily controlled-release tablets, Naprelan®):
Adults: Usual dosage is 750 or 1000 mg PO once daily. Smaller doses may be required in individual patients. Minimum dosage: 375 mg PO once daily. Maximum dosage (limited time periods): 1500 mg PO once daily.
for self-medication of osteoarthritis:
NOTE: Self-medication should not exceed 10 days unless otherwise directed.
Oral dosage (naproxen sodium, Aleve® caplets, tablets, or gelcaps):
Adults and adolescents: 220 mg (1 caplet, tablet or gelcap) PO every 8 - 12 hours. For the first dose, 440 mg (2 caplets, tablets, or gelcaps) may be taken within the first hour. Maximum OTC dosage is 660 mg/day PO and not more than 440 mg PO in any 8 - 12 hour period unless otherwise directed by a clinician.
Elderly: 220 mg (1 caplet, tablet or gelcap) PO every 12 hours. Maximum OTC dosage is 440 mg/day PO unless otherwise directed by a clinician.
Children: Safe and effective self-medication has not been established.
for the treatment of juvenile rheumatoid arthritis (JRA) or other inflammatory conditions in children:
Oral dosage (naproxen tablets or oral suspension, Naprosyn®):
Children >= 2 years: 5 mg/kg PO twice daily. Dosage ranges from 7 - 20 mg/kg/day. Maximum dosage is 1000 mg/day.
Children < 2 years: Safe and effective use has not been established.
For the treatment of acute gouty arthritis:
NOTE: Extended-release naproxen is not recommended due to the absorption delay as compared to immediate-release formulations and controlled-release naproxen sodium.
Oral dosage (naproxen tablets or oral suspension, Naprosyn®):
Adults: Initially 750 mg PO, then 250 mg PO every 8 hours until symptoms subside.
Oral dosage (naproxen sodium tablets, Anaprox®, Anaprox DS®):
Adults: Initially, 825 mg PO, then 275 mg PO every 8 hours until symptoms subside.
Oral dosage (naproxen sodium, controlled-release tablets, Naprelan®):
Adults: 1000 - 1500 mg PO once on the first day, followed by 1000 mg PO once daily until the attack has subsided.
For the treatment of mild pain to moderate pain, including dysmenorrhea, acute tendinitis and bursitis, headache, bone pain † , dental pain, arthralgia, and myalgia:
NOTE: Extended-release naproxen is not recommended due to the absorption delay as compared to immediate-release formulations and controlled-release naproxen sodium.
Oral dosage (naproxen tablets or suspension, Naprosyn®):
Adults: Initially, 500 mg PO, followed by 250 mg PO every 6 - 8 hours as needed. Do not exceed 1250 mg on day 1 or 1000 mg/day on subsequent days.
Children: 5 - 7 mg/kg PO every 8 - 12 hours.
Oral dosage (naproxen sodium tablets, Anaprox®, Anaprox DS®):
Adults: Initially, 550 mg PO, followed by 275 mg PO every 6 - 8 hours or 550 mg PO every 12 hours as needed. Do not exceed 1375 mg on day 1 or 1100 mg/day on subsequent days.
Oral dosage (naproxen sodium controlled-release tablets, Naprelan®):
Adults: 1000 mg PO once daily. May be increased to 1500 mg PO once daily for a limited period, if needed.
for self-medication:
NOTE: Self-medication should not exceed 10 days unless otherwise directed.
Oral dosage (naproxen sodium, Aleve® caplets, tablets, or gelcaps):
Adults and adolescents: 220 mg (1 caplet, tablet or gelcap) PO every 8 - 12 hours. For the first dose, 440 mg (2 caplets, tablets, or gelcaps) may be taken within the first hour. Maximum OTC dosage 660 mg/day PO and not more than 440 mg PO in any 8 - 12 hour period unless otherwise directed by a clinician.
Elderly: 220 mg mg (1 caplet, tablet or gelcap) PO every 12 hours. Maximum OTC dosage 440 mg/day PO unless otherwise directed by a clinician.
Children: Safe and effective self-medication has not been established.
for the treatment of acute, severe headache or migraine † :
NOTE: Naproxen sodium is preferred over naproxen due to a faster onset of action.
Oral dosage (naproxen, tablets or oral suspension, Naprosyn®):
Adults: Doses of 500 mg PO 2 - 3 times daily have been recommended. Alternatively, some studies have recommended a single dose of 750 mg at the onset of migraine.
Oral dosage (naproxen sodium tablets, Anaprox®, Anaprox DS®):
Adults: Doses of 825 mg PO at onset, and then a dose of 275 - 550 mg PO in 60 minutes have been recommended.
For chronic migraine prophylaxis † :
Oral dosage (naproxen, tablets or oral suspension, Naprosyn®):
Adults: 250 mg PO 2 - 3 times a day. Do not exceed 1000 mg/day.
Oral dosage (naproxen sodium tablets, Anaprox®, Anaprox DS®):
Adults: Clinical trials suggest a dose of 550 mg PO twice daily.
For self-medication of fever:
NOTE: Self-medication should not exceed 3 days unless otherwise directed.
Oral dosage (naproxen sodium, Aleve® caplets, tablets, or gelcaps):
Adults and adolescents: 220 mg (1 caplet, tablet or gelcap) PO every 8 - 12 hours. For the first dose, 440 mg (2 caplets, tablets, or gelcaps) may be taken within the first hour. Maximum OTC dosage 660 mg/day PO and not more than 440 mg PO in any 8 - 12 hour period unless otherwise directed by a clinician.
Elderly: 220 mg (1 caplet, tablet or gelcap) PO every 12 hours. Maximum OTC dosage 440 mg/day PO unless otherwise directed by a clinician.
Children: Safe and effective self-medication has not been established.
For the prevention of heterotopic ossification † :
Oral dosage (naproxen tablets or oral suspension, Naprosyn®):
Adults: 250 mg PO 3 times daily for the first 6 weeks after a total hip replacement led to heterotopic ossification degree 1 or 2 according to Brooker in 30.8% of 26 patients; none had degree 3 or 4. In contrast, of 28 patients who got placebo, 46.4% had degree 1 or 2 and 32.1% had grade 3. In another study, severe ossification developed within a year of the procedure in none of the 27 patients who took naproxen 500 mg PO twice daily for the first 7 days after cemented total hip arthroplasty; 4 patients had lesser degrees of heterotopic ossification. As a comparison, 12 of 23 patients who had not received any kind of nonsteroidal anti-inflammatory drug had heterotopic ossification, and 3 cases were severe.
Maximum Dosage Limits:
Adults: Naproxen 1500 mg/day PO; naproxen sodium 1650 mg/day PO; controlled release naproxen sodium 1500 mg/day PO. For non-prescription use, 660 mg/day PO and not more than 440 mg PO in any 8 - 12 hour period unless directed by a physician.
Elderly: Naproxen 1500 mg/day PO; naproxen sodium 1650 mg/day PO; controlled release naproxen sodium 1500 mg/day PO. For non-prescription use, 440 mg/day PO unless directed by a physician.
Adolescents: Naproxen 1500 mg/day PO; naproxen sodium 1650 mg/day PO; controlled release naproxen sodium 1500 mg/day PO.
Children >= 2 years: Naproxen 20 mg/kg/day PO not to exceed 1000 mg/day PO; non-prescription (self medication) use is not recommended.
Children < 2 years: Safe and effective use has not been established.
Patients with hepatic impairment:
Although specific guidelines are not available, dosage reduction may be necessary in patients with hepatic dysfunction.
Patients with renal impairment:
CrCl >= 20 ml/min: No dosage adjustment needed.
CrCl < 20 ml/min: Accumulation of metabolites may occur; close monitoring for adverse reactions requiring dosage reduction is recommended.
† non-FDA-approved indication
[ Last revised: 2/17/2006 3:08:00 PM ]
References
. Diamond S. Migraine headaches. Med Clin N Am 1991;75:545 - 66.
. Schulman EA, Silberstein SD. Symptomatic and prophylactic treatment of migraine and tension-type headache. Neurology 1992;42(suppl 2):16 - 21.
. Welch KMA, Ellis DJ, Keenan, PA. Successful migraine prophylaxis with naproxen sodium. Neurology 1985;35:1304 - 10.
. Vielpeau C, Joubert JM, Hulet C. Naproxen in the prevention of heterotopic ossification after total hip replacement. Clin Orthop 1999;369:279 - 88.
. Gebuhr PH, Wilbek H, Soelberg M. Eight days of naproxen therapy can prevent heterotopic ossification after total hip alloplasty. Ugeskrift for Laeger 1996;158:1076 - 8.
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