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Drug Catalog - Product Detail

NAPROXEN DR 500MG TB 100

NDC Mfr Size Str Form
69784-0500-01 WOODWARD PHARMA SERVICES 100 500MG TABLET
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Generic Name
NAPROXEN
Substance Name
NAPROXEN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA020067
Description
11 DESCRIPTION NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. Naproxen is a propionic 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 has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14 H 14 NaO 3 . Naproxen and naproxen sodium have the following structures, respectively: 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. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING NAPROXEN (naproxen) tablets 500 mg: yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100. Supplied as: NDC 69784-505-01 100's (bottle) Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. EC-NAPROXEN (naproxen) 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. Supplied as: NDC 69784-501-01 100's (bottle) 500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. Packaged in light-resistant bottles of 100. Supplied as: NDC 69784-500-01 100's (bottle) Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. NAPROXEN SODIUM (naproxen sodium) Tablets 550 mg: dark blue, oblong-shaped tablets, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100. Supplied as: NDC 69784-550-01 100's (bottle) Store at 15° to 30°C (59° to 86°F) in well-closed containers.
Indications & Usage
1 INDICATIONS AND USAGE NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis NAPROXEN Tablets and NAPROXEN SODIUM are also indicated for: the relief of signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis NAPROXEN Tablets and NAPROXEN SODIUM are also indicated for: the relief of signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis NAPROXEN Tablets 250 mg (one-half tablet) 500 mg twice daily NAPROXEN SODIUM 275 mg (one-half tablet) 550 mg twice daily EC-NAPROXEN 375 mg or 500 mg twice daily To maintain the integrity of the enteric coating, the EC-NAPROXEN tablet should not be broken, crushed or chewed during ingestion. The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses well, the dose may be increased to naproxen 1,500 mg/day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis NAPROXEN Tablets may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate. Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. Dosing with NAPROXEN Tablets is not appropriate for children weighing less than 50 kilograms. Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis Recommended starting dose 550 mg of naproxen sodium as NAPROXEN SODIUM 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. NAPROXEN SODIUM is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Acute Gout Recommended starting dose 750 mg of NAPROXEN Tablets followed by 250 mg every 8 hours until the attack has subsided. NAPROXEN SODIUM may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours. EC-NAPROXEN is not recommended because of the delay in absorption. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM and other treatment options before deciding to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . After observing the response to initial therapy with NAPROXEN Tablets, EC-NAPROXEN or NAPROXEN SODIUM, the dose and frequency should be adjusted to suit an individual patient's needs. To maintain the integrity of the enteric coating, the EC-NAPROXEN tablet should not be broken, crushed or chewed during ingestion. Naproxen-containing products such as NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion. 2.2 Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis The recommended dosages of NAPROXEN Tablets, NAPROXEN SODIUM, and EC-NAPROXEN are shown in Table 1. Table 1: Recommended dosages for NAPROXEN Tablets, NAPROXEN SODIUM, and EC-NAPROXEN NAPROXEN Tablets 250 mg (one-half tablet) 500 mg twice daily NAPROXEN SODIUM 275 mg (one-half tablet) 550 mg (naproxen 500 mg with 50 mg sodium) twice daily EC- NAPROXEN 375 mg or 500 mg twice daily 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 administration of the drug more frequently than twice daily does not generally make a difference in response. 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. 2.3 Polyarticular Juvenile Idiopathic Arthritis Naproxen solid-oral dosage forms may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate for weight-based dosing and due to the need for dose flexibility in children. 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 (12) ] . The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. Dosing with NAPROXEN tablets is not appropriate for children weighing less than 50 kilograms. 2.4 Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of NAPROXEN SODIUM (naproxen sodium) tablets is 550 mg followed by 550 mg every 12 hours or 275 mg (one half of a 550 mg tablet) every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg (two and one-half tablets) 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, NAPROXEN SODIUM is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. NAPROXEN Tablets may also be used. The recommended starting dose of NAPROXEN Tablets is 500 mg followed by 250 mg (one half of a 500 mg NAPROXEN tablet) every 6-8 hours as required.. The total daily dose should not exceed 1250 mg of naproxen. EC-NAPROXEN is not recommended for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products [see Clinical Pharmacology (12) ] . 2.5 Acute Gout The recommended starting dose is 750 mg (one and one-half tablets) of NAPROXEN Tablets followed by 250 mg (one-half tablet) every 8 hours until the attack has subsided. NAPROXEN SODIUM may also be used at a starting dose of 825 mg (one and one-half tablets) followed by 275 mg (one-half tablet) every 8 hours. EC-NAPROXEN is not recommended because of the delay in absorption. 2.6 Non-Interchangeability with Other Formulations of Naproxen Different dose strengths and formulations (e.g., tablets, suspension) of naproxen are not interchangeable. This difference should be taken into consideration when changing strengths or formulations.