Naprosyn

Carefully consider the potential benefits and risks of NAPROSYN,
EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension
and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN,
ANAPROX, ANAPROX DS and NAPROSYN Suspension. Use the lowest effective
dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with NAPROSYN, EC-NAPROSYN,
ANAPROX, ANAPROX DS or NAPROSYN Suspension, the dose and frequency
should be adjusted to suit an individual patient's needs.
Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily
bioequivalent. This difference should be taken into consideration when changing formulation.
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.
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.
Studies indicate that although total plasma concentration
of naproxen is unchanged, the unbound plasma fraction of naproxen
is increased in the elderly. Caution is advised when high doses are
required and some adjustment of dosage may be required in elderly
patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Naproxen-containing products are not recommended
for use in patients with moderate to severe renal impairment
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis:
NAPROSYN    250 mg or 375 mg or 500 mg twice daily
 275 mg (naproxen 250 mg with 25 mg sodium) twice daily
ANAPROX DS    550 mg (naproxen 500 mg with 50 mg sodium)    twice daily
NAPROSYN Suspension    250 mg (10 mL/2 tsp) or 375 mg (15 mL/3 tsp or 500 mg) or  (20 mL/4 tsp) twice daily
EC-NAPROSYN    375 mg 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. NAPROSYN Suspension should be shaken gently before use.
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/day for
limited periods of up to 6 months 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.  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 .
The use of NAPROSYN Suspension is recommended for
juvenile arthritis in children 2 years or older because it allows
for more flexible dose titration based on the child's weight. 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.
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

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. 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. 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.
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, INDICATIONS
AND USAGE).).

Carefully consider the potential benefits and risks of NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). 

After observing the response to initial therapy with NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension, the dose and frequency should be adjusted to suit an individual patient's needs.

Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.

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 WARNINGS and PRECAUTIONS).

Geriatric Patients

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.

Patients With Moderate to Severe Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis

NAPROSYN 250 mg
or 375 mg
or 500 mg twice daily
twice daily
twice daily ANAPROX 275 mg (naproxen 250 mg with 25 mg sodium) twice daily ANAPROX DS 550 mg (naproxen 500 mg with 50 mg sodium) twice daily NAPROSYN Suspension 250 mg (10 mL/2 tsp)
or 375 mg (15 mL/3 tsp)
or 500 mg (20 mL/4 tsp) twice daily
twice daily
twice daily EC-NAPROSYN 375 mg
or 500 mg twice daily
twice daily

To maintain the integrity of the enteric coating, the EC-NAPROSYN tablet should not be broken, crushed or chewed during ingestion. NAPROSYN Suspension should be shaken gently before use.

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/day for limited periods of up to 6 months 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.  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 is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child's weight. 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 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. 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. 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).

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).

Carefully consider the potential benefits and risks of NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). 

After observing the response to initial therapy with NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension, the dose and frequency should be adjusted to suit an individual patient's needs.

Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.

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 WARNINGS and PRECAUTIONS).

Geriatric Patients

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.

Patients With Moderate to Severe Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis

NAPROSYN 250 mg
or 375 mg
or 500 mg twice daily
twice daily
twice daily ANAPROX 275 mg (naproxen 250 mg with 25 mg sodium) twice daily ANAPROX DS 550 mg (naproxen 500 mg with 50 mg sodium) twice daily NAPROSYN Suspension 250 mg (10 mL/2 tsp)
or 375 mg (15 mL/3 tsp)
or 500 mg (20 mL/4 tsp) twice daily
twice daily
twice daily EC-NAPROSYN 375 mg
or 500 mg twice daily
twice daily

To maintain the integrity of the enteric coating, the EC-NAPROSYN tablet should not be broken, crushed or chewed during ingestion. NAPROSYN Suspension should be shaken gently before use.

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/day for limited periods of up to 6 months 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.  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 is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child's weight. 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 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. 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. 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).

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).