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Naprosyn

"Nov. 1, 2013 (San Diego)- Women who drink one or more sugar-sweetened sodas a day might raise their risk of getting rheumatoid arthritis, according to a new study that links RA risk to the sugary habit. The study does not prove cause and ef"...

Naprosyn, Anaprox, Anaprox DS

Naprosyn, Anaprox, Anaprox DS

INDICATIONS

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

Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension is indicated:

  • For the relief of the signs and symptoms of rheumatoid arthritis
  • For the relief of the signs and symptoms of osteoarthritis
  • For the relief of the signs and symptoms of ankylosing spondylitis
  • For the relief of the signs and symptoms of 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 is also indicated:

  • For relief of the signs and symptoms of tendonitis
  • For relief of the signs and symptoms of bursitis
  • For relief of the signs and symptoms of acute gout
  • For the management of pain
  • For the management of primary dysmenorrhea

EC-NAPROSYN 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

Carefully consider the potential benefits and risks of NAPROSYN, ECNAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension and other treatment options before deciding to use NAPROSYN, ECNAPROSYN, 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, ECNAPROSYN, 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 twice daily
or 375 mg twice daily
or 500 mg 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) 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. 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 ½ 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 (½ 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 ½ 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. ECNAPROSYN is not recommended because of the delay in absorption (see CLINICAL PHARMACOLOGY).

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.

100's (bottle): NDC 0004-6314-01.

500 mg: yellow, capsule-shaped, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100.

100's (bottle): NDC 0004-6316-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in lightresistant 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. Shake gently before use.

EC-NAPROSYN Delayed-Release Tablets: 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. Packaged in lightresistant bottles of 100.

100's (bottle): NDC 0004-6415-01.

500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. 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 lightresistant 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, oblongshaped, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100.

100's (bottle): NDC 0004-6203-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers.

Distributed by: Genentech USA, Inc., A member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: March 2013

Last reviewed on RxList: 4/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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