Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
ScieGen Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Naproxen sodium tablets 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 Naproxen sodium tablets are also indicated for: the relief of the signs and symptoms of: - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea Naproxen sodium 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
Naproxen Sodium Tablets USP, 275 mg are white, capsule-shaped, film coated tablets debossed with “432” on one side and “SG” on other side. Bottles of 30 NDC 50228-432-30 Bottles of 100 NDC 50228-432-01 Bottles of 500 NDC 50228-432-05 Bottles of 1,000 NDC 50228-432-10 Naproxen Sodium Tablets USP, 550 mg are white, capsule-shaped, film coated tablets, debossed with “433” on one side and “S & G” on either side of functional scoreline on the other side. Bottles of 30 NDC 50228-433-30 Bottles of 100 NDC 50228-433-01 Bottles of 500 NDC 50228-433-05 Bottles of 1,000 NDC 50228-433-10 Store at 15° to 30°C (59° to 86°F) in well-closed containers.
Abbreviated New Drug Application
NAPROXEN SODIUM - naproxen sodium tablet ScieGen Pharmaceuticals, Inc. ---------- Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 5/2021 What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • if you have had a Read the complete document
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET NAPROXEN SODIUM - NAPROXEN SODIUM TABLET SCIEGEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN SODIUM TABLETS. 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) Naproxen sodium 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 ( 5.10, 5.11) 04/2021 INDICATIONS AND USAGE Naproxen sodium tablets 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 Naproxen sodium tablets are also indicated for: the relief of the signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • pain • primary dysmenorrhea (1) 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 Read the complete document