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Palmetto Pharmaceuticals Drugs
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 (see WARNINGS).
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.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although Naproxen Oral Suspension and other formulations of naproxen and naproxen sodium circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
Naproxen Oral Suspension
250 mg (10 mL/2 tsp)
or 375 mg (15 mL/3 tsp)
or 500 mg (20 mL/4 tsp)
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 the administration of the drug more frequently than twice daily is not necessary.
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. 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 (see CLINICAL PHARMACOLOGY).
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 (see CLINICAL PHARMACOLOGY).
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). 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 bid
2.5 mL (1/2 tsp) twice daily
25 kg (55 lb)
125 mg bid
5.0 mL (1 tsp) twice daily
38 kg (84 lb)
187.5 mg bid
7.5 mL (1 1/2 tsp) twice daily
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
The recommended starting dose is 500 mg (20 mL or 4 teaspoonfuls) of Naproxen Oral Suspension, followed by 500 mg every 12 hours, or 250 mg (10 mL or 2 teaspoonfuls) every 6 to 8 hours as required. The initial total daily dose should not exceed 1250 mg (50 mL or 10 teaspoonfuls). Thereafter, the total daily dose should not exceed 1000 mg (40 mL or 8 teaspoonfuls).
The recommended starting dose of naproxen is 750 mg (30 mL or 6 teaspoonfuls), followed by 250 mg (10 mL or 2 teaspoonfuls) every 8 hours until the attack has subsided.
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