What is Naproxen and how is it used?
Naproxen is a prescription medicine used to treat the symptoms of pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, gout or menstrual cramps. Naproxen may be used alone or with other medications.
Naproxen is a nonsteroidal anti-inflammatory medication (NSAID).
It is not known if Naproxen is safe and effective in children younger than 2 years of age.
What are the possible side effects of Naproxen?
Naproxen may cause serious side effects including:
- shortness of breath,
- swelling or rapid weight gain,
- skin rash or blisters,
- bloody or tarry stools,
- coughing up blood or vomit that looks like coffee grounds,
- upper stomach pain ,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- little or no urination ,
- painful urination,
- swelling in your feet or ankles,
- anemia (low red blood cells),
- pale skin,
- tiredness ,
- feeling lightheaded, and
- cold hands or feet
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Naproxen include:
- heartburn, and
- flu symptoms
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Naproxen. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
NAPROXEN Tablets, EC-NAPROXEN, and ANAPROX DS are indicated for:
the relief of the signs and symptoms of:
- rheumatoid arthritis
- ankylosing spondylitis
- Polyarticular Juvenile Idiopathic Arthritis
NAPROXEN Tablets and ANAPROX DS are also indicated for:
the relief of signs and symptoms of:
the management of:
- primary dysmenorrhea
DOSAGE AND ADMINISTRATION
General Dosing Instructions
Carefully consider the potential benefits and risks of NAPROXEN Tablets, EC-NAPROXEN and ANAPROX DS and other treatment options before deciding to use NAPROXEN Tablets, EC-NAPROXEN and ANAPROX DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
After observing the response to initial therapy with NAPROXEN Tablets, EC-NAPROXEN 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-NAPROXEN tablet should not be broken, crushed or chewed during ingestion.
Naproxen-containing products such as NAPROXEN, EC-NAPROXEN and ANAPROX DS, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion.
Rheumatoid Arthritis, Osteoarthritis And Ankylosing Spondylitis
The recommended dosages of NAPROXEN Tablets, ANAPROX DS, and EC-NAPROXEN are shown in Table 1.
Table 1: Recommended dosages for NAPROXEN Tablets, ANAPROX DS, and EC-NAPROXEN
|NAPROXEN||250 mg (one half tablet) 500 mg||twice daily|
|ANAPROX DS||275 mg (one half tablet) 550 mg (naproxen 500 mg with 50 mg sodium)||twice daily|
|EC-NAPROXEN||375 mg||twice daily|
|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 the administration of the drug more frequently than twice daily is not necessary.
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.
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]. 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.
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. 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].
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. 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-NAPROXEN is not recommended because of the delay in absorption.
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.
Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers.