Naproxendosage

2 DOSAGE & ADMINISTRATION Use the lowest effective dose for shortest duration consistent with individual patient treatment goals. Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen oralsuspension 250 mg (10 mL) twice daily or 375 mg (15 mL) twice daily or 500 mg (20 mL) twice daily 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 1500 mg/day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. The following table may be used as a guide for dosing of naproxen oral suspension: Patient's Weight Dose Administered as 13 kg (29 lb) 62.5 mg twice daily 2.5 mL (1/2 tsp) twice daily 25 kg (55 lb) 125 mg twice daily 5 mL (1 tsp) twice daily 38 kg (84 lb) 187.5 mg twice daily 7.5 mL (1 1/2 tsp) twice daily Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of naproxen oral suspension is 500 mg (20 mL), followed by 250 mg (10 mL) every 6 to 8 hours as required. Acute Gout The recommended starting dose is 750 mg (30 mL) of naproxen oral suspension followed by 250 mg (10 mL) every 8 hours until the attack has subsided

2.1 General

Dosing Instructions Carefully consider the potential benefits and risks of naproxen oral suspension and other treatment options before deciding to use naproxen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy with naproxen oral suspension, the dose and frequency should be adjusted to suit an individual patient’s needs. Always use a calibrated measuring device when administering naproxen oral suspension to ensure the dose is measured and administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half of a teaspoonful is to be measured. Given the variability of the household spoon measure, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend an appropriate measuring device that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage. Naproxen-containing products such as naproxen oral suspension 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 dosage of naproxen oral suspension is shown in Table 1.

Table 1: Recommended dosages of naproxen oral suspension Naproxen oral suspension 250 mg (10 mL) twice daily or 375 mg (15 mL) twice daily or 500 mg (20 mL) twice daily Naproxen oral suspension should be shaken gently before use. 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 The use of naproxen oral suspension is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child’s weight. 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. The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). A measuring cup marked in 1/2 teaspoon and 2.5 milliliter increments is provided with the naproxen oral suspension. The following table may be used as a guide for dosing of naproxen oral suspension: Patient’s Weight Dose Administered as 13 kg (29 lb) 62.5 mg twice daily 2.5 mL (1/2 tsp) twice daily 25 kg (55 lb) 125 mg twice daily 5.0 mL (1 tsp) twice daily 38 kg (84 lb) 187.5 mg twice daily 7.5 mL (1 1/2 tsp) twice daily

2.4 Management of

Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of naproxen oral suspension is 500 mg (20 mL), followed by 250 mg (10 mL) every 6 to 8 hours as required. The total daily dose should not exceed 1250 mg (50 mL).

2.5 Acute Gout

The recommended starting dose is 750 mg (30 mL) of naproxen oral suspension followed by 250 mg (10 mL) every 8 hours until the attack has subsided.

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.