Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Alvogen Inc.
NAPROXEN SODIUM
NAPROXEN 375 mg
ORAL
PRESCRIPTION DRUG
Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: - rheumatoid arthritis (RA) - osteoarthritis (OA) - ankylosing spondylitis (AS) - tendinitis, bursitis - acute gout - primary dysmenorrhea (PD) - the relief of mild to moderate pain [see Warnings and Precautions (5) ]. Naproxen Sodium Controlled-Release 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) ] Risk Summary Use of NSAIDs, including Naproxen Sodium Controlled-Release Tablets, can cause premature closure o
Naproxen sodium 375 mg, 500 mg, and 750 mg are controlled-release tablets supplied as: 375 mg: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 47781-153-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen. 500 mg: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 47781-154-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen. 750 mg: white, capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; NDC 47781-155-30. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen. Storage Store at room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a well-closed container.
New Drug Application Authorized Generic
Alvogen Inc. ---------- MEDICATION GUIDE Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) 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: o with increasing doses of NSAIDs o 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: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o 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 medical conditions, including if you: • have liver or ki Læs hele dokumentet
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ALVOGEN INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS. NAPROXEN SODIUM CONTROLLED-RELEASE 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 CONTROLLED-RELEASE 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) INDICATIONS AND USAGE Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)(1) osteoarthritis (OA)(1) ankylosing spondylitis (AS)(1) tendinitis, bursitis (1) acute gout (1) primary dysmenorrhea (PD)(1) the relief of mild to moderate pain (1) DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2) RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily. Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiri Læs hele dokumentet