A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Naprosyn Indications, Dosage, Storage, Stability - Naproxen
Naprosyn Indications, Dosage, Storage, Stability - Naproxen
INDICATIONS
AND USAGE
Naproxen as NAPROSYN, EC- NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension
are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis and juvenile arthritis.
Naproxen as NAPROSYN Suspension is recommended for juvenile rheumatoid arthritis
in order to obtain the maximum dosage flexibility based on the patient’s weight.
Naproxen as NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension are also
indicated for the treatment of tendonitis, bursitis, acute gout, and for the
management of pain and primary dysmenorrhea. ECNAPROSYN is not recommended for
initial treatment of acute pain because the absorption of naproxen is delayed
compared to absorption from other naproxen- containing products ( see CLINICAL
PHARMACOLOGY and DOSAGE AND ADMINISTRATION
).
DOSAGE AND ADMINISTRATION
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis:
NAPROSYN 250 mg twice daily or 375 mg twice daily or 500 mg twice daily
ANAPROX 275 mg twice daily ( naproxen 250 mg with 25 mg sodium)
ANAPROX DS 550 mg twice daily ( naproxen 500 mg with 50 mg sodium)
NAPROSYN Suspension 250 mg ( 10 mL/ 2 tsp) twice daily or 375 mg ( 15 mL/
3 tsp) twice daily or 500 mg ( 20 mL/ 4 tsp) twice daily
EC- NAPROSYN 375 mg twice daily or 500 mg twice daily
To maintain the integrity of the enteric coating, the EC- NAPROSYN tablet should
not be broken, crushed or chewed during ingestion.
During long- term administration, the dose of naproxen may be adjusted up or
down depending on the clinical response of the patient. A lower daily dose may
suffice for long- term administration. The morning and evening doses do not
have to be equal in size and the administration of the drug more frequently
than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen
1500 mg per day for limited periods when a higher level of anti- inflammatory/
analgesic activity is required. When treating such patients with naproxen 1500
mg/ day, the physician should observe sufficient increased clinical benefits
to offset the potential increased risk ( see CLINICAL
PHARMACOLOGY and INDIVIDUALIZATION
OF DOSAGE).
Juvenile Arthritis: The recommended total daily dose of naproxen
is approximately 10 mg/ kg given in 2 divided doses ( ie, 5 mg/ kg given twice
a day). A measuring cup marked in 1/ 2 teaspoon and 2.5 milliliter increments
is provided with the NAPROSYN Suspension. The following table may be used as
a guide for dosing of NAPROSYN Suspension:
Patient’s Weight Dose Administered as
13 kg ( 29 lb) 62.5 mg bid 2.5 mL ( 1/ 2 tsp) twice daily
25 kg ( 55 lb) 125 mg bid 5.0 mL ( 1 tsp) twice daily
38 kg ( 84 lb) 187.5 mg bid 7.5 mL ( 1 1/ 2 tsp) twice daily
Management of Pain, Primary Dysmenorrhea and Acute Tendonitis and Bursitis:
The recommended starting dose is 550 mg of naproxen sodium as ANAPROX/ ANAPROX
DS followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required.
The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter,
the total daily dose should not exceed 1100 mg of naproxen sodium. NAPROSYN
may also be used but EC- NAPROSYN is not recommended for initial treatment of
acute pain because absorption of naproxen is delayed compared to other naproxen-
containing products ( see CLINICAL PHARMACOLOGY,
INDICATIONS
AND USAGE and INDIVIDUALIZATION
OF DOSAGE).
Acute Gout: The recommended starting dose is 750 mg of NAPROSYN
followed by 250 mg every 8 hours until the attack has subsided. ANAPROX may
also be used at a starting dose of 825 mg followed by 275 mg every 8 hours.
EC- NAPROSYN is not recommended because of the delay in absorption ( see CLINICAL
PHARMACOLOGY).
INDIVIDUALIZATION OF DOSAGE
Although NAPROSYN, NAPROSYN Suspension, EC- NAPROSYN, ANAPROX and ANAPROX DS
all circulate in the plasma as naproxen, they have pharmacokinetic differences
that may affect onset of action. Onset of pain relief can begin within 30 minutes
in patients taking naproxen sodium and within 1 hour in patients taking naproxen.
Because EC- NAPROSYN dissolves in the small intestine rather than in the stomach,
the absorption of the drug is delayed compared to the other naproxen formulations
( see CLINICAL PHARMACOLOGY).
The recommended strategy for initiating therapy is to choose a formulation
and a starting dose likely to be effective for the patient and then adjust the
dosage based on observation of benefit and/ or adverse events. A lower dose
should be considered in patients with renal or hepatic impairment or in elderly
patients ( see PRECAUTIONS).
Analgesia/ Dysmenorrhea/ Bursitis and Tendonitis: Because the
sodium salt of naproxen is more rapidly absorbed, ANAPROX/ ANAPROX DS is recommended
for the management of acute painful conditions when prompt onset of pain relief
is desired. The recommended starting dose is 550 mg followed by 550 mg every
12 hours or 275 mg every 6 to 8 hours, as required. The initial total daily
dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily
dose should not exceed 1100 mg of naproxen sodium. NAPROSYN may also be used
for treatment of acute pain and dysmenorrhea. EC- NAPROSYN is not recommended
for initial treatment of acute pain because absorption of naproxen is delayed
compared to other naproxen- containing products ( see CLINICAL
PHARMACOLOGY and INDICATIONS
AND USAGE).
Acute Gout: The recommended starting dose is 750 mg of NAPROSYN
followed by 250 mg every 8 hours until the attack has subsided. ANAPROX may
also be used at a starting dose of 825 mg followed by 275 mg every 8 hours as
needed. EC- NAPROSYN is not recommended because of the delay in absorption (
see CLINICAL PHARMACOLOGY).
Osteoarthritis/ Rheumatoid Arthritis/ Ankylosing Spondylitis:
The recommended dose of naproxen is NAPROSYN or NAPROSYN Suspension 250 mg,
375 mg or 500 mg taken twice daily ( morning and evening) or ECNAPROSYN 375
mg or 500 mg taken twice daily. Naproxen sodium may also be used ( see DOSAGE
AND ADMINISTRATION).
During long- term administration the dose of naproxen may be adjusted up or
down depending on the clinical response of the patient. A lower daily dose may
suffice for long- term administration. In patients who tolerate lower doses
well, the dose may be increased to 1500 mg per day when a higher level of anti-
inflammatory/ analgesic activity is required. When treating patients with naproxen
1500 mg/ day ( as NAPROSYN or 1650 mg of ANAPROX), the physician should observe
sufficient increased clinical benefit to offset the potential increased risk.
The morning and evening doses do not have to be equal in size and administration
of the drug more frequently than twice daily does not generally make a difference
in response ( see CLINICAL PHARMACOLOGY).
Juvenile Arthritis: The use of NAPROSYN Suspension allows for
more flexible dose titration. In pediatric patients, doses of 5 mg/ kg/ day
produced plasma levels of naproxen similar to those seen in adults taking 500
mg of naproxen ( see CLINICAL PHARMACOLOGY).
The recommended total daily dose is approximately 10 mg/ kg given in two divided
doses ( ie, 5 mg/ kg given twice a day) ( see DOSAGE
AND ADMINISTRATION).
HOW SUPPLIED
NAPROSYN Tablets: 250 mg: round, yellow, biconvex, engraved with NPR
LE 250 on one side and scored on the other. Packaged in light- resistant bottles
of 100.
100’ s ( bottle): NDC 0004- 6313- 01.
375 mg: pink, biconvex oval, engraved with NPR LE 375 on one side. Packaged
in light- resistant bottles of 100 and 500.
100’ s ( bottle): NDC 0004- 6314- 01; 500’ s ( bottle): NDC 0004- 6314- 14.
500 mg: yellow, capsule- shaped, engraved with NPR LE 500 on one side and scored
on the other. Packaged in lightresistant bottles of 100 and 500.
100’ s ( bottle): NDC 0004- 6316- 01; 500’ s ( bottle): NDC 0004- 6316- 14.
Store at 15 ° to 30 ° C ( 59 ° to 86 ° F) in well- closed containers; dispense
in light- resistant containers.
NAPROSYN Suspension: 125 mg/ 5 mL ( contains 39 mg sodium, about 1.5
mEq/ teaspoon): Available in 1 pint ( 473 mL) light- resistant bottles ( NDC
0004- 0028- 28).
Store at 15 ° to 30 ° C ( 59 ° to 86 ° F); avoid excessive heat, above 40 °
C ( 104 ° F). Dispense in light- resistant containers.
EC- NAPROSYN Delayed- Release Tablets: 375 mg: white, capsule- shaped,
imprinted with EC- NAPROSYN on one side and 375 on the other. Packaged in light-
resistant bottles of 100.
100’ s ( bottle): NDC 0004- 6415- 01.
500 mg: white, capsule- shaped, imprinted with EC- NAPROSYN on one side and
500 on the other. Packaged in light- resistant bottles of 100.
100’ s ( bottle): NDC 0004- 6416- 01.
Store at 15 ° to 30 ° C ( 59 ° to 86 ° F) in well- closed containers; dispense
in light- resistant containers.
ANAPROX Tablets: Naproxen sodium 275 mg: light blue, oval- shaped, engraved
with NPS- 275 on one side.
Packaged in bottles of 100.
100’ s ( bottle): NDC 0004- 6202- 01.
Store at 15 ° to 30 ° C ( 59 ° to 86 ° F) in well- closed containers.
ANAPROX DS Tablets: Naproxen sodium 550 mg: dark blue, oblong- shaped,
engraved with NPS 550 on one side and scored on both sides. Packaged in bottles
of 100 and 500.
100’ s ( bottle): NDC 0004- 6203- 01; 500’ s ( bottle): NDC 0004- 6203- 14.
Store at 15 ° to 30 ° C ( 59 ° to 86 ° F) in well- closed containers.
* ALEVE is a registered trademark of Bayer- Roche L. L. C.
Rx only
Distributed by:
27897585- 0501
Revised: May 2001
Copyright © 1999- 2001 by Roche Laboratories Inc. All
rights reserved.
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