Clinical Information
Gen. Code and Des.
8358 naproxen sodium ORAL TABLET 550 MG
GCN and Des.
47131 naproxen sodium ORAL TABLET 550 MG
Strength
550MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS
92160000 ANTIGOUT AGENTS
Active Ingredients
2381 naproxen sodium 26159342
These highlights do not include all the information needed to use NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS safely and effectively. See full prescribing information for NAPROSYN, EC-NAPROSYN and ANAPROX DS.
NAPROSYN® (naproxen) tablets,
EC-NAPROSYN® (naproxen delayed-release tablets),
ANAPROX® DS (naproxen sodium tablets), for oral use
Initial U.S. Approval: 1976
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.
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. (5.1)
NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
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. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 04/2021
INDICATIONS AND USAGE
NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
NAPROSYN Tablets and ANAPROX DS are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
NAPROSYN Tablets 250 mg (one-half tablet)
500 mg twice daily
ANAPROX DS 275 mg (one-half tablet)
550 mg twice daily
EC-NAPROSYN 375 mg
or 500 mg twice daily
To maintain the integrity of the enteric coating, the EC-NAPROSYN tablet should not be broken, crushed or chewed during ingestion.
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
NAPROSYN Tablets may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. A liquid formulation may be more appropriate. Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. Dosing with NAPROSYN Tablets is not appropriate for children weighing less than 50 kilograms.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
Recommended starting dose 550 mg of naproxen sodium as ANAPROX DS followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. ANAPROX DS is recommended for the management of acute painful conditions when prompt onset of pain relief is desired.
Acute Gout
Recommended starting dose 750 mg of NAPROSYN Tablets followed by 250 mg every 8 hours until the attack has subsided. ANAPROX DS may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours. EC-NAPROSYN is not recommended because of the delay in absorption.
DOSAGE FORMS AND STRENGTHS
NAPROSYN® (naproxen) tablets: 500 mg
EC-NAPROSYN® (naproxen) delayed-release tablets: 375 mg and 500 mg
ANAPROX® DS (naproxen sodium) tablets: 550 mg (contains 50 mg of sodium)
CONTRAINDICATIONS
Known hypersensitivity to naproxen or any components of the drug product (4)
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. (5.3)
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. (5.4, 7)
Heart Failure and Edema: Avoid use of NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.5)
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. (5.6)
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.7)
Exacerbation of Asthma Related to Aspirin Sensitivity: NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.8)
Serious Skin Reactions: Discontinue NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS at first appearance of skin rash or other signs of hypersensitivity. (5.9)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10)
Fetal Toxicity: Limit use of NSAIDs, including NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (5.11, 8.1)
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)
ADVERSE REACTIONS
Most common adverse reactions to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Canton Laboratories LLC.at1-844-302-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs):
Monitor patients for bleeding who are concomitantly taking NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS with drugs that interfere with hemostasis. Concomitant use of NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS and analgesic doses of aspirin is not generally recommended. (7)
ACE inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS may diminish the antihypertensive effect of these drugs. Monitor blood pressure. (7)
ACE Inhibitors and ARBs: Concomitant use with NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. (7)
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. (7)
Digoxin: Concomitant use with NAPROSYN Tablets, EC-NAPROSYN or ANAPROX DS can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. (7)
USE IN SPECIFIC POPULATIONS
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS in women who have difficulties conceiving. (8.3)
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). (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2021
