Naprosyn

NAPROSYN- naproxen suspension
Athena Bioscience, LLC

1 INDICATIONS AND USAGE

NAPROSYN (naproxen) Suspension is indicated for:

the relief of the signs and symptoms of:

• rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis
• tendonitis
• bursitis
• acute gout

the management of:

• pain
• primary dysmenorrhea

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

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

Always use a calibrated measuring device when administering NAPROSYN 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 NAPROSYN 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 NAPROSYN suspension is shown in Table 1.

Table 1: Recommended dosages of NAPROSYN Suspension

NAPROSYN Suspension

250 mg (10 mL)or 375 mg (15 mL)or 500 mg (20 mL)

twice dailytwice dailytwice daily

NAPROSYN 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 NAPROSYN 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 (12 .3) ]

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 NAPROSYN Suspension. The following table may be used as a guide for dosing of NAPROSYN 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 NAPROSYN 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 NAPROSYN 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.

3 DOSAGE FORMS AND STRENGTHS

NAPROSYN suspension: 125 mg/5 mL (contains 39 mg sodium): Available in 1 pint (473 mL) light-resistant bottles.

4 CONTRAINDICATIONS

NAPROSYN Suspension is 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 Cardiovascular Thrombotic Events) ]

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as naproxen, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2) ]

Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4) ]

Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of NAPROSYN Suspension in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If NAPROSYN Suspension is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.