NAPROXEN- naproxen tablet
Aphena Pharma Solutions — Tennessee, LLC
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ].
- Naproxen Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4), Warnings and Precautions (5.1)].
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 Tablets are indicated for: the relief of the signs and symptoms of:
- rheumatoid arthritis
- ankylosing spondylitis
- Polyarticular Juvenile Idiopathic Arthritis
- acute gout
the management of:
- primary dysmenorrhea
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
Carefully consider the potential benefits and risks of Naproxen Tablets and other treatment options before deciding to use Naproxen Tablets. 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 Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Naproxen-containing products such as Naproxen Tablets 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 dosages of Naproxen Tablets are shown in Table 1.
Table 1: Recommended dosages for Naproxen Tablets
|Naproxen Tablets||250 mg 375 mg 500 mg||twice daily twice daily 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 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 per 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 per day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk.
2.3 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 (12)]. 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.
2.4 Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
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 1,250 mg of naproxen.
2.5 Acute Gout
The recommended starting dose is 750 mg of Naproxen tablets followed by 250 mg 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 Tablets USP, 250 mg are light yellow, round shaped tablets debossed with “SG” along with break-line on one side and”434″ on the other side.
Naproxen Tablets USP, 375 mg are light yellow, capsule shaped tablets debossed with “SG” on one side and “435” on the other side.
Naproxen Tablets USP, 500 mg are light yellow, oblong shaped tablets debossed with “SG” along with break-line on one side and “436” on the other side.
Naproxen tablets are 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) ]
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 to 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) ].
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 naproxen in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If naproxen tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
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