Naproxen

NAPROXEN- naproxen suspension
Amneal Pharmaceuticals NY LLC

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Gastrointestinal 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 oral 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 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 and Precautions (5)].

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)or 375 mg (15 mL)or 500 mg (20 mL) twice dailytwice dailytwice 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 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 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

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 (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 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 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 1,250 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.

3 DOSAGE FORMS AND STRENGTHS

Naproxen oral suspension, USP: 125 mg/5 mL (contains 38.95 mg sodium): Available in 1 pint (473 mL) light-resistant bottles

4 CONTRAINDICATIONS

Naproxen oral 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)]

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