NAPROSYN, EC-NAPROSYN, ANAPROX DS Tablet, Delayed-release tablet Ref.[28002] Active ingredients: Naproxen

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS and other treatment options before deciding to use NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS. 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 NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS, the dose and frequency should be adjusted to suit an individual patient’s needs.

To maintain the integrity of the enteric coating, the EC-NAPROSYN tablet should not be broken, crushed or chewed during ingestion.

Naproxen-containing products such as NAPROSYN, EC-NAPROSYN and ANAPROX DS, 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 NAPROSYN Tablets, ANAPROX DS, and EC-NAPROSYN are shown in Table 1.

Table 1. Recommended dosages for NAPROSYN Tablets, ANAPROX DS, and EC-NAPROSYN:

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 NAPROSYN 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 ANAPROX DS (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, ANAPROX DS is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. NAPROSYN Tablets may also be used. The recommended starting dose of NAPROSYN Tablets is 500 mg followed by 250 mg (one half of a 500 mg NAPROSYN tablet) every 6-8 hours as required. The total daily dose should not exceed 1250 mg of naproxen.

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 (12)].

2.5 Acute Gout

The recommended starting dose is 750 mg (one and one-half tablets) of NAPROSYN Tablets followed by 250 mg (one-half tablet) every 8 hours until the attack has subsided. ANAPROX DS 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-NAPROSYN 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.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2)].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 [see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)].

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

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