Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Preferred Pharmaceuticals Inc.
NAPROXEN SODIUM
NAPROXEN SODIUM 550 mg
ORAL
PRESCRIPTION DRUG
Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: the management of: Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including naproxen tablets or naproxen sodium tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including naproxen tablets or naproxen sodium tablets, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of naproxen tablets or naproxen sodium tablets in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of dr
Naproxen Sodium Tablets, USP, 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. Packaged in bottles of.; 14’s (bottle): NDC 68788-6934-4 20’s (bottle): NDC 68788-6934-2 30’s (bottle): NDC 68788-6934-3 60’s (bottle): NDC 68788-6934-6 90’s (bottle): NDC 68788-6934-9 100’s (bottle): NDC 68788-6934-0 120’s (bottle): NDC 68788-6934-8 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers.
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Non-Steroidal 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 • older age • longer use of NSAIDs • poor health • smoking • advanced liver disease • drinking alcohol • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed 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 an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDS, tell your healthcare provider about all of your Read the complete document
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS AND 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._ • • • INDICATIONS AND USAGE Naproxen tablets and naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: (1) the relief of the signs and symptoms of: (1) • • • • Naproxen tablets and naproxen sodium tablets are also indicated for: (1) the relief of signs and symptoms of: (1) • • • the management of: (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 tablets 250 mg (one-half tablet) 500 mg twice daily Naproxen sodium tablets 275 mg (one-half tablet) 550 mg 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 1500 mg/ day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis 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 and 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, w Read the complete document