Naproxen 375 mg Immediate Release Tablets — Generic For Naprosyn — ScieGen

These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS.

NAPROXEN 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)

Naproxen tablets 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 (5.9)11/2024

Indications And Usage

Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for:

the relief of the signs and symptoms of:

(1)

rheumatoid arthritis

osteoarthritis

ankylosing spondylitis

polyarticular juvenile idiopathic arthritis

tendonitis

bursitis

acute gout

the management of: (1)

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

Naproxen Tablets250 mg

375 mg

500 mg

twice daily

twice daily

twice daily

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 1,500 mg/day for up to 6 months.

Polyarticular Juvenile Idiopathic Arthritis

Naproxen 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 naproxen tablets is not appropriate for children weighing less than 50 kilograms.

Acute Gout

Recommended starting dose 750 mg of naproxen Tablets followed by 250 mg every 8 hours until the attack has subsided.

Dosage Forms And Strengths

Naproxen tablets: 250 mg, 375 mg and 500 mg

(3)

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

• (5.9) 11/2024 INDICATIONS AND USAGE Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: (1)
• rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis
• tendonitis
• bursitis
• acute gout the management of: (1)

• (5.9) 11/2024 INDICATIONS AND USAGE Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: (1)
• rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis
• tendonitis
• bursitis
• acute gout the management of: (1)

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 naproxen tablets 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 naproxen tablets 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:Naproxen tablets are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

(5.8)

Serious Skin Reactions:Discontinue naproxen tablets 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 naproxen Tablets, 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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 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 Naproxen Tablets with drugs that interfere with hemostasis. Concomitant use of naproxen Tablets and analgesic doses of aspirin is not generally recommended.

(7)

ACE inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with naproxen Tablets may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

(7)

ACE Inhibitors and ARBs: Concomitant use with naproxen Tablets 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 naproxen Tablets 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 naproxen Tablets 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: 1/2026