Label: NAPROSYN - naproxen tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/09

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  • 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 C14H14O3. Naproxen sodium has a molecular weight
    of 252.23 and a molecular formula of C14H13NaO3.

    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,
    freely soluble in water at neutral pH.

    NAPROSYN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow
    tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are  croscarmellose sodium, iron oxides,povidone and magnesium stearate.

    EC-NAPROSYN
    (naproxen delayed-release tablets) is available as enteric-coatedwhite tablets containing 375 mg of naproxen and 500 mg of naproxen
    for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion
    contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated
    naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.

    ANAPROX (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and ANAPROX DS (naproxen sodium tablets) for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. 

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  • CLINICAL PHARMACOLOGY

    Naproxen is a nonsteroidal anti-inflammatory drug

    (NSAID) with analgesic and antipyretic properties. The sodium salt

    of naproxen has been developed as a more rapidly absorbed formulation

    of naproxen for use as an analgesic. The mechanism of action of the

    naproxen anion, like that of other NSAIDs, is not completely understood

    but maybe related to prostaglandin synthetase inhibition.

    Naproxen and naproxen sodium are rapidly and completely

    absorbed from the gastrointestinal tract with an in vivo bioavailability

    of 95%. The different dosage forms of NAPROSYN are bioequivalent in

    terms of extent of absorption (AUC) and peak concentration (Cmax); however, the products do differ in their pattern of absorption.

    These differences between naproxen products are related to both the

    chemical form of naproxen used and its formulation. Even with the

    observed differences in pattern of absorption, the elimination half-life

    of naproxen is unchanged across products ranging from 12 to 17 hours.

    Steady-state levels of naproxen are reached in 4 to 5 days, and the

    degree of naproxen accumulation is consistent with this half-life.

    This suggests that the differences in pattern of release play only

    a negligibie role in the attainment of steady-state plasma levels.

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  • INDICATION AND USAGE

    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.
    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.

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  • CONTRADICTIONS

    NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN
    Suspension are contraindicated in patients with known hypersensitivity
    to naproxen and naproxen sodium.

    NAPROSYN, EC-NAPROSYN,
    ANAPROX, ANAPROX DS and NAPROSYN Suspension should not be given to
    patients who have experienced asthma, urticaria, or allergic-type
    reactions after taking aspirin or other NSAIDs. Severe, rarely fatal,
    anaphylactic-like reactions to NSAIDs have been reported in such patients

    NAPROSYN, EC-NAPROSYN,
    ANAPROX, ANAPROX DS and NAPROSYN Suspension are contraindicated for
    the treatment of peri-operative pain in the setting of coronary artery
    bypass graft (CABG) surgery.

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  • Adverse Reactions

    Adverse reactions reported in controlled clinical
    trials in 960 patients treated for rheumatoid arthritis or osteoarthritis
    are listed below. In general, reactions in patients treated chronically
    were reported 2 to 10 times more frequently than they were in short-term
    studies in the 962 patients treated for mild to moderate pain or for
    dysmenorrhea. The most frequent complaints reported related to the
    gastrointestinal tract.

    A clinical study found
    gastrointestinal reactions to be more frequent and more severe in
    rheumatoid arthritis patients taking daily doses of 1500 mg naproxen
    compared to those taking 750 mg naproxen (see  CLINICAL PHARMACOLOGY).

    In controlled clinical trials with about
    80 pediatric patients and in well-monitored, open-label studies with
    about 400 pediatric patients with juvenile arthritis treated with
    naproxen, the incidence of rash and prolonged bleeding times were
    increased, the incidence of gastrointestinal and central nervous system
    reactions were about the same, and the incidence of other reactions
    were lower in pediatric patients than in adults.

    In patients taking naproxen in clinical trials, the most frequently
    reported adverse experiences in approximately 1% to 10% of patients
    are:

    Gastrointestinal
    (GI) Experiences, including: heartburn1, abdominal pain1, nausea1, constipation1, diarrhea, dyspepsia,
    stomatitis

    Central
    Nervous System: headache1, dizziness1, drowsiness1, lightheadedness,
    vertigo

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  • OVERDOSAGE

    Significant naproxen overdosage may be characterized

    by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort,

    heartburn, indigestion, nausea, transient alterations in liver function,

    hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea,

    disorientation or vomiting. Gastrointestinal bleeding can occur. Hypertension,

    acute renal failure, respiratory depression, and coma may occur, but

    are rare. Anaphylactoid reactions have been reported with therapeutic

    ingestion of NSAIDs, and may occur following an overdose. Because

    naproxen sodium may be rapidly absorbed, high and early blood levels

    should be anticipated. A few patients have experienced convulsions,

    but it is not clear whether or not these were drug-related. It is

    not known what dose of the drug would be life threatening. The oral

    LD50 of the drug is 543 mg/kg in rats, 1234 mg/kg in mice,

    4110 mg/kg in hamsters, and greater than 1000 mg/kg in dogs.


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  • Dosage and Administration

    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).).

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  • 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 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: September
    2007

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  • Medication Guide Approval

    This Medication Guide has
    been approved by the U.S. Food and Drug Administration.

    Medication Guide Revised: July 2008

    All registered trademarks in this document are the property of their
    respective owners.

    Distributed by:

    Roche Laboratories Inc.

    340 Kingsland
    Street

    Nutley, NJ 07110–1199

    10095543

    Copyright © 1999-2008 by Roche Laboratories Inc. All rights
    reserved.

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  • PRINCIPAL DISPLAY PANEL

    MM1

    image of product



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  • INGREDIENTS AND APPEARANCE
    NAPROSYN 
    naproxen tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-3202(NDC:53746-188)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN (NAPROXEN) NAPROXEN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    CROSCARMELLOSE SODIUM  
    Product Characteristics
    Color white (whitecolor) Score no score
    Shape ROUND (roundnoscore) Size 4mm
    Flavor Imprint Code IP188;250
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-3202-1 30 in 1 BOTTLE
    2 NDC:63629-3202-2 60 in 1 BOTTLE
    3 NDC:63629-3202-3 20 in 1 BOTTLE
    4 NDC:63629-3202-4 120 in 1 BOTTLE
    5 NDC:63629-3202-5 10 in 1 BOTTLE
    6 NDC:63629-3202-6 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075927 09/01/2009
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 repack(63629-3202)
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