NAPRELAN (Page 5 of 5)

OVERDOSAGE

Significant naproxen overdosage may be characterized by drowsiness, heartburn, indigestion, nausea or vomiting. Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced seizures, 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 500 mg/kg in rats, 1200 mg/kg in mice, 4000 mg/kg in hamsters and greater than 1000 mg/kg in dogs. In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of naproxen.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic carthartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of NAPRELAN® and other treatment options before deciding to use NAPRELAN®. 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 NAPRELAN® , the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of:

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis

The recommended starting dose of NAPRELAN® Tablets in adults is two NAPRELAN® 375 mg tablets (750 mg) once daily, one NAPRELAN® 750 mg (750 mg) once daily, or two NAPRELAN® 500 mg tablets (1000 mg) once a daily. Patients already taking naproxen 250 mg, 375 mg, or 500mg twice daily (morning and evening) may have their total daily dose replaced with NAPRELAN® Tablets as a single daily dose.

During long-term administration, the dose of NAPRELAN® Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of NAPRELAN® Tablets well, the dose may be increased to two NAPRELAN® 750 mg tablets (1500 mg), or three NAPRELAN® 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see CLINICAL PHARMACOLOGY). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.

A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see PRECAUTIONS). Studies indicate that although total plasma contcentration 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.

Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis

The recommended starting dose is two NAPRELAN® 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, two NAPRELAN® 750 mg tablets (1500 mg) or three NAPRELAN® 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two NAPRELAN® 500 mg tablets (1000 mg). The NAPRELAN® DOSE CARD provides a 10 day tapered dose regimen contained in a single blister dose pack that provides 1500 mg given once daily (two NAPRELAN® 750 mg tablets) for 3 days, with a taper to 1000 mg given once daily (two NAPRELAN® 500 mg tablets) for the remaining 7 days.

Acute Gout

The recommended dose on the first day is two to three NAPRELAN® 500 mg tablets (1000 — 1500 mg) once daily, followed by two NAPRELAN® 500 mg tablets (1000 mg) once daily, until the attack has subsided.

HOW SUPPLIED

NAPRELAN® (naproxen sodium) Controlled-Release Tablets are available as follows:

NAPRELAN® 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 68453-375-10. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.
NAPRELAN® 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 68453-850-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.
NAPRELAN® 750: white-capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; 68453-777-03; in bottles of 60; NDC 68453-777-06. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.
NAPRELAN® DOSE CARD: contains six 750 mg white-capsule-shaped tablets with “N” on one side and “750” on the reverse (3 days of therapy) and fourteen 500 mg white, capsule-shaped tablets with “N” on one side and “500” on the reverse (7 days of therapy) in a single blister card; NDC 68453-900-02.

Rx Only

US Patent 5,637,320

Store at controlled room temperature, 20° — 25° C (68° — 77° F).

Dispense in a well-closed container.

______________________________________________________________

* Registered Trademark of Elan Corporation plc

** Registered Trademark of Elan Pharma Int. Ltd.

*** Naprosyn ® is a registered trademark of Syntex Puerto Rico, Inc.

Manufactured for: Victory Pharma, Inc., San Diego, CA 92130

Manufactured by: Elan Pharma International Ltd., Athlone, Ireland

PI3750107

Rev 8/09

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

( See the end of this Medication Guide for a list of prescription NSAID medicines.)

NAPRELAN ®
(naproxen sodium)
CONTROLLED-RELEASE TABLETS

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 death._

This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anti-coagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

________________________________________________

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine.
  • for pain right before or after heart bypass surgery.

Tell your healthcare provider:

  • about all your medical conditions
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include:

  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma

Other side effects include:

  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speach
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medial advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription

* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, NAPRELAN, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

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

NAPRELAN 750MG LABEL IMAGE
(click image for full-size original)

NAPRELAN
naproxen sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-242(NDC:68453-777)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 750 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TALC
HYPROMELLOSE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code N;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-242-30 30 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 12/19/2008
Labeler — STAT RX USA (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA 786036330 repack, relabel

Revised: 03/2010 STAT RX USA

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