NAPROXEN SODIUM- naproxen sodium tablet
PD-Rx Pharmaceuticals, Inc.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
ardiovascular Thrombotic Events
- N onsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)] .
- N a p r o x e n sodium tablets a r e contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), Warnings and Precautions (5.1)].
G astrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ] .
1 INDICATIONS AND USAGE
Naproxen sodium tablets are indicated for:
The relief of the signs and symptoms of:
- rheumatoid arthritis
- ankylosing spondylitis
- Polyarticular Juvenile Idiopathic Arthritis
Naproxen sodium tablets are also indicated for:
The relief of signs and symptoms of:
- acute gout
The management of:
- primary dysmenorrhea
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
Carefully consider the potential benefits and risks of naproxen sodium tablets and other treatment options before deciding to use naproxen sodium tablets. 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 sodium tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Naproxen-containing products such as naproxen tablets, naproxen delayed-release tablets and naproxen sodium tablets, 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 sodium tablets, are shown in Table 1.
T a ble 1: Recommended dosages for Naproxen Sodium Tablets
Naproxen sodium tablets
275 mg (naproxen 250 mg with 25 mg sodium)
Naproxen sodium tablets
550 mg (naproxen 500 mg with 50 mg sodium)
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 1,500 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 1,500 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 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 1,375 mg (two and one-half tablets) of naproxen sodium. Thereafter, the total daily dose should not exceed 1,100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired.
2.5 Acute Gout
The recommended starting dose is 825 mg (one and one-half tablets) of naproxen sodium tablets followed by 275 mg (one-half tablet) every 8 hours.
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.
3 DOSAGE FORMS AND STRENGTHS
Naproxen Sodium Tablets, USP 275 mg, blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse.
Naproxen Sodium Tablets, USP 550 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse.
Naproxen Sodium Tablets are contraindicated in the following patients:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions (5.7, 5.9)]
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)]
- In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]
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