NAPROSYN- naproxen tablet EC-NAPROSYN- naproxen tablet, delayed release ANAPROX DS- naproxen sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

naproxen (UNII: 57Y76R9ATQ) (naproxen - UNII:57Y76R9ATQ)

Available from:

Genentech, Inc.

INN (International Name):

naproxen

Composition:

naproxen 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN, 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 r

Product summary:

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 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. 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 light-resistant 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 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.     100's (bottle): NDC 0004-6203-01. Store at 15° to 30°C (59° to 86°F) in well-closed containers. Revised: March 2013

Authorization status:

New Drug Application

Patient Information leaflet

EC-NAPROSYN® (naproxen delayed-release tablets)
NAPROSYN® (naproxen tablets) ANAPROX®/ANAPROX® DS
(naproxen sodium tablets) NAPROSYN® (naproxen
suspension)

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NAPROSYN-
naproxen tablet  EC-NAPROSYN-
naproxen tablet, delayed release 
ANAPROX DS- naproxen sodium tablet 
Genentech, Inc.
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Medication Guide for Non-steroidal Anti-Inflammatory Drugs
(NSAIDs)
(See the end of this
Medication Guide for a list of prescription NSAID
medicines.)

What is the most important information
I should know about medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance
of a heart attack or stroke that can lead to

Read the complete document

Summary of Product characteristics

NAPROSYN- NAPROXEN TABLET
EC-NAPROSYN- NAPROXEN TABLET, DELAYED RELEASE
ANAPROX DS- NAPROXEN SODIUM TABLET
GENENTECH, INC.
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EC-NAPROSYN (NAPROXEN DELAYED-RELEASE TABLETS)
NAPROSYN (NAPROXEN TABLETS)
ANAPROX /ANAPROX DS (NAPROXEN SODIUM TABLETS)
NAPROSYN (NAPROXEN SUSPENSION)
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN
Suspension is contraindicated for the treatment of peri-operative pain
in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding,
ulceration, and perforation of the stomach or intestines, which can be
fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients are at greater risk
for serious gastrointestinal events (see WARNINGS).
DESCRIPTION
Naproxen is a proprionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical names for naproxen and naproxen sodium are
(S)-6-methoxy-α-methyl-2-
naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic
acid, sodium salt, respectively.
Naproxen and naproxen sodium have the following structures,
respectively:
Naproxen has a molecular weight of 230.26 and a molecular formula of C
H O . Naproxen sodium
has a molecular weight of 252.23 and a molecular formula of C
H NaO .
Naproxen is an odorless, white to off-white crystalline substance. It
is lipid-soluble, practically
insoluble in water at low pH and freely soluble in water at high pH.
The octanol/water partition
coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium is a
white to creamy white, crystalline
solid, fre